Name: Use of a Foot-Induced Digitally Controlled Resistance Device for Functional Magnetic Resonance Imaging Evaluation in Patients with Foot Paresis (Video) | JoVE Journal
Uploaded: 2023-07-07T12:20:00.000+00:00
Duration: 8 min 55 s
Description: Learn a novel MRI-compatible foot motion device for evaluating brain activity during walking tasks in chronic stroke patients. This method establishes biomarkers to justify extended rehabilitation therapy and assess outcomes.

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5 minutes

This work was supported by a grant from the National Institute of Neurological Disorders and Stroke (Grant number 1R01NS105875-01A1) of the National Institutes of Health to A. Aria Tzika. This work was performed at the Athinoula A. Martinos Center for Biomedical Imaging. We wish to thank Director Dr. Bruce R. Rosen, M.D., Ph.D. and members of the Martinos Center staff, and Dr. Michael Moskowitz, M.D., for their advice and support. Lastly, we thank Virtumed, LLC for the manufacture of the device.

All the experiments were approved by the Institutional Review Board at Massachusetts General Hospital and performed as approved at the Athinoula A. Martinos Center for Biomedical Imaging. Subject consent for the use and sharing of de-identified data was obtained.
NOTE: In the current study, the inclusion criteria were as follows: (1) right or left hemiparesis with residual leg movement from an ischemic/MCA stroke incurred &#8805;6 months earlier; (2) a Functional Ambulation Category (FAC) score30 of 4-5 (subject ambulates with an assistant to navigate stairs/uneven surfaces or without the help of an assistant); (3) a National Institutes of Health Stroke Scale (NIHSS)31 score of 5-14 (mild/moderate); (4) the ability to stand for 5 min and walk&#160;10 m; (5) aged 18-80 years old. Following initial testing, an additional criterion was included, which involved verifying that the subjects could move the pedal through at least 5&#176; of motion with the paretic foot. Data were collected on demographics, stroke risk factors, the duration of physical/occupational therapy, the length of the hospital stay during the acute stage, medication use, intercurrent infections, and complications.
1. Subject screening and preparation
<ol>
	<li>During recruitment, meet with the potential subjects, and test their ability to move the device&#39;s pedals with their paretic foot.
	<ol>
		<li>Check the fit of each subject&#39;s foot in the device&#39;s foot pedals. For subjects with smaller feet, test the fit of their feet when wearing sneakers or similar footwear that are MR-safe.</li>
		<li>Subjects who cannot exert sufficient force to move the pedal through at least a 5&#176; range of motion with the device un-energized should be excluded from the study.</li>
	</ol>
	</li>
	<li>Prior to arrival, instruct the subjects to bring the tested footwear if this was determined to be necessary during the pre-screening. Record the subject information, and obtain informed consent according to the institutional protocol.</li>
	<li>On each testing day, screen the subjects for contraindications as specified by the MR facility policy. Obtain signed waivers in cases of subjects with tattoos with the potential for irritation and/or burning sensations and any other facility-specific waivers.</li>
	<li>Instruct the subject to change into a facility-approved gown/pants and to wait to be called into the scanner room. Store the subject&#39;s belongings as per facility policy. If determined to be needed, instruct the subject to put on the footwear.</li>
</ol>
2. Setup of the controlled-resistance foot device
NOTE: It is recommended that the completion of steps 2.1-2.3 occurs prior to the subject&#39;s arrival.
<ol>
	<li>Setup in the MRI support room
	<ol>
		<li>Place the HV amplifier unit with the attached DAQ module on the floor close to the penetration panel. Plug the AC power cord into the wall outlet, plug the HV coaxial cable into the HV amplifier terminals and into the MHV coaxial plug on the penetration panel, and plug the sensor cable into the corresponding plug on the penetration panel. Turn on the main power switch of the HV amplifier.</li>
		<li>Plug the USB B plug of the USB cable into the DAQ module and the USB A plug of the cable into the USB repeater cable. Lay the USB repeater cable out from the MRI support room to the MRI control room, and fasten the cable to the floor using adhesive tape as necessary to prevent dislodgement by staff or subject ambulation about the facility.</li>
		<li>Activate scanner room projector.</li>
	</ol>
	</li>
	<li>Setup in the MRI control room
	<ol>
		<li>Place the foot-device host laptop adjacent to the MRI scanner interface, plug in the power supply, and power up the laptop. Start the MATLAB application, and load the user interface (UI) program.</li>
		<li>Plug the MRI scanner button box/trigger signal USB cable, the scanner room projector cable, and the USB repeater cable into the laptop.</li>
		<li>If not previously set up, adjust the laptop monitor settings so that the main window is extended onto the projector screen to the right of the main laptop window. Move the mouse pointer off the right side of the main laptop window, and confirm that it moves into the field of view of the projector screen. Move the mouse pointer back to the main window. 
		NOTE: The trigger signal and projector cable formats may differ between facilities. Video adapters or similar units may be necessary.</li>
	</ol>
	</li>
	<li>Setup in the scanner room
	<ol>
		<li>Verify that the scanner table is fully outside of the scanner bore and lowered completely.</li>
		<li>Mount a head coil into its corresponding slot on the scanner table. Remove the top section of the coil, and place it to the side. Cover the scanner table cushions and the lower section of the head coil with a hospital bed sheet.</li>
		<li>Mount the projector screen into the bore at the opposite end from the scanner table.</li>
		<li>Insert two pairs of brass mounting screws into the coil mounting slots toward the foot end of the scanner table, and place the foot device between the screw pairs. Loosely attach plastic retaining brackets to the screws and alignment holes in the base plate of the foot device (Figure 1A).</li>
		<li>Attach the sensor and HV cables to the plugs on the penetration panel. Ensure the cables are not looped around the table or otherwise at risk of pinching or tangling when the table is moved into the scanner bore. Ensure that the sensor and HV cables are extended without loops between the foot device and the penetration panel.</li>
		<li>Start the UI program in the control room (run the m-file script), and verify that communications have been established between the host laptop and the DAQ module by observing the confirmation message in the UI (Figure 3).</li>
		<li>Accept the default force level proportions on the initial UI dialog by clicking on the OK button. Wait for confirmation dialogs to appear and dismiss themselves and for the initial force and displacement live graph window to appear.</li>
		<li>Ensure that, while one staff member moves the pedal of the foot device through its range of motion and another staff member observes the force and displacement traces, the displacement trace moves from &#8722;35&#176; to +18&#176; and back and that the force trace shows positive forces for motions in the dorsiflexion direction, negative forces for motions in the plantar flexion direction, and returns to zero at rest. This confirms the function of the sensors, DAQ module, HV amplifier, and ERF actuator (Figure 3A).</li>
		<li>If the signals appear normal, click on Continue on the live graph window, and then the Shutdown button on the confirmation dialog. If not, check the cable connections and power connections, and redo the setup steps as necessary.</li>
	</ol>
	</li>
	<li>Subject and foot device alignment
	<ol>
		<li>Escort the subject from the waiting room into the scanner room. Perform metal screening as per facility policy to check for unreported objects or implants. Provide the subject with protective ear plugs.</li>
		<li>Instruct the subject to sit on the table and then to lie supine with their head nestled in the lower section of the head coil. Provide assistance as needed. Fit padding between the subject&#39;s head and the walls of the head coil to ensure that head motion is prevented during imaging.</li>
		<li>Instruct the subject to straighten their legs. Move the foot device toward/away from the subject until their heels (or the heels of their shoes) rest in the foot seats of the foot device. Adjust further to align the main pivot of the pedals with the subject&#39;s ankles.</li>
		<li>Fasten the foot device in place using the plastic retaining brackets and plastic wing nuts.</li>
		<li>Instruct the subject to remove the foot not being tested from its pedal and rest it slightly proximal from the foot device. Support the non-tested leg with pillows as necessary. Fasten the tested foot into its foot device pedal with hook-and-loop retaining straps, ensuring the ball of the subject&#39;s foot (or the front of the subject&#39;s shoe) is in contact with the pedal. 
		NOTE: In the current study, with the non-control (stroke) subjects, the stroke-affected foot was tested first. After the testing of the affected foot was complete, that foot was removed from the pedal, and the non-affected foot was mounted in the corresponding pedal using the same process as in step 2.4.5.</li>
		<li>Provide a squeeze-bulb alarm device to the subject, instruct them to squeeze the bulb to test it, and remind the subject that, at any time, they may squeeze the bulb to communicate with the technicians.</li>
		<li>Raise the MR table to full height so the subject can see the projection screen through the mirror assembly.</li>
		<li>Install the upper section of the head coil, and mount the viewing mirror assembly over the head coil. Verify that the subject can see the projector screen clearly in the mirror.</li>
	</ol>
	</li>
</ol>
3. Subject strength testing
<ol>
	<li>Restart the UI. Accept the default force level proportions, or adjust them if required by the study protocol, and click on the OK button as above. When the force/displacement traces have appeared, instruct the subject to move the tested foot as far as possible in the dorsiflexion direction and return to full plantar flexion three times. Verify that the displacement and force traces appear normal as above. This establishes the range of motion for testing, which may be less than that of the full range of the foot device (Figure 3A).</li>
	<li>If the results are acceptable, click on Continue on the live graph window and Yes - Proceed on the confirmation dialog; click on No-Retry if the subject did not follow the flexion instructions correctly; or click on Go to Shut down if there are other problems, and troubleshoot as necessary.</li>
	<li>When presented with the date/time confirmation dialog, click on Yes - Proceed on the dialog, or click on other options if a different filename or shutdown is desired.</li>
	<li>Instruct the subject to move their tested foot to full plantar flexion, and click on OK on the confirmation dialog. An instruction/metronome window will appear (labeled in Figure 3). Using the mouse, drag this window into the field of view of the projection screen, and click on OK to confirm that this has been completed.</li>
	<li>Verify that the instructions for the subject are displayed on the projector. Verify that the subject&#39;s foot remains in full plantar flexion, and click on OK on the corresponding dialog. The UI graph changes to the dynamometer display with indications of the resistance force set points.</li>
	<li>The visual metronome described above appears on the projection screen with a solid, target circle moving up or down on the screen at a constant speed and an open circular cursor controlled by the foot device pedal position. Instruct the subject to move their foot to cause the cursor to follow the motion of the target closely. If the subject can successfully move through their full range of motion while following the target, click on (Fd, Fp) + 10 on the live graph to increase the force set points for both dorsiflexion and plantar flexion (Figure 3B).</li>
	<li>Observe whether the subject continues to track the metronome motion accurately.
	<ol>
		<li>If so, click on (Fd, Fp) + 10 again to increase both the force set points. If dorsiflexion cannot be completed but plantar flexion continues to follow the target motion, click on (Fd, Fp) - 10 once and click on Fp + 10 twice to reduce the dorsiflexion resistance force by one step and increase the plantar resistance by one step.</li>
		<li>If&#160;the dorsiflexion force has been set but the subject can no longer track the metronome in plantar-flexion, click on Fp - 10 once, and then click on Continue in the live graph window. The current force levels are used by the UI program as reference points for the proportionally reduced forces applied during the testing phase.</li>
		<li>If the plantar flexion force set point has reached the maximum setting of the foot device, press Continue in the live graph, and proceed. 
		NOTE: Step 3.7.3 generally occurs for control subjects with normal leg strength and for the unaffected limb in stroke subjects due to them exceeding the capabilities of the device, which is designed to focus on the strength in the affected limb.</li>
		<li>Record the force set points (shown on the right of the force trace plot) for future reference. Click on Yes - Proceed to continue, No - Test Again to repeat, or Shutdown if there are other problems. Instruct the subject to move the tested foot to full plantar displacement and then to relax.</li>
	</ol>
	</li>
	<li>Review the use of the squeeze bulb, the scanning sequence, and the task with the subject, and answer any questions the subject may have prior to the initiation of the scans.</li>
	<li>Instruct the subject to close their eyes during this step. Use the scanner&#39;s landmarking laser line to locate the head coil/subject&#39;s head position. Move the table to center the subject&#39;s head within the scanner bore. Have the staff leave the scanner room and close the door.</li>
</ol>
4. Running the MRI scan session and foot device task
<ol>
	<li>Perform facility-specific registration of the subject, and load the scan protocol. Notify the subject that the anatomical scan sequence will begin and that they may relax during this portion of the protocol, and instruct them to squeeze the bulb to verify their understanding. Initiate the anatomical scan, and wait for completion.</li>
	<li>As directed by the dialog window provided by the UI, notify the subject that the fMRI and foot-device portion of the study will begin, and instruct them that they should ensure that their foot under testing is in full plantar flexion, that they should return their foot to full plantar flexion when a fixation cross appears on the screen, and that they should follow the visual metronome when it appears. Click on OK on the instruction dialog.</li>
	<li>Follow the instruction that directs the operator to prepare the scanner control computer to initiate the fMRI portion of the protocol. Click on OK in the instruction dialog window, and start the fMRI sequence. The UI program automatically sends the desired force settings to the DAQ module. 
	NOTE: In the current study, the visual metronome task was performed three times each for the stroke-affected and unaffected limbs at force levels of 60%, 40%, and 20% of the maximum levels set in step 3.7. The force levels are updated automatically for each repetition of the test.</li>
	<li>The subject views their instructions displayed on the projector screen. A &#34;+&#34; sign (fixation cross) appears, during which, as previously instructed, the subject rests.</li>
	<li>The visual metronome target is displayed with the solid circle moving up and down at constant speed. As previously instructed, the subject moves their tested foot in dorsiflexion and plantar flexion to cause the open circular cursor to track the target. 
	NOTE: In the current study, the rest (fixation cross) and active (metronome) phases were of equal length, and the cycle was repeated seven times. During the metronome phase, there were two cycles of dorsiflexion and plantar flexion through the range of motion. These parameters may be adjusted in the UI script for other studies. Each fMRI/metronome phase lasted approximately 5 min 40 s.</li>
	<li>Repeat step 4.4 and step 4.5 for a total of seven cycles, after which the fixation cross is displayed and the subject rests.</li>
	<li>Repeat steps 4.2-4.6 for a total of three cycles.</li>
	<li>Enter the MRI scanner room, and switch the foot mounted in the foot device as per step 2.4.5. Repeat protocol section 3 for the second foot.</li>
	<li>Repeat protocol section 4, bypassing step 4.1 and step 4.8 (registration, anatomical scan, switching foot).</li>
	<li>Notify the subject that the DTI portion of the scan will commence and that they may relax during this phase of the study, and instruct them to squeeze the bulb to confirm their understanding. Initiate the DTI scan, and wait for completion.</li>
</ol>
5. Post-test operations
<ol>
	<li>Move the table and subject out of the scanner bore, and lower the table. Remove the mirror assembly, the upper head coil section, and the padding about the subject&#39;s head. The ear protection may be discarded at this time.</li>
	<li>Assist the subject to a sitting position and to move to the changing area if necessary. The subject may now change back into their regular clothing.</li>
	<li>Talk to the subject, address any post-test questions they may have, arrange the scheduling of future appointments, and complete the stipend payment forms prior to the subject&#39;s departure.</li>
	<li>Disassemble and pack the hardware, and unmount the ankle device from the scanner table. Detach the HV and sensor cables from the penetration panel. Detach the button box and monitor cables from the host laptop. Pack the ankle device and supporting hardware into carry cases.</li>
	<li>Perform facility-specific sanitation of the scanner table and relevant work surfaces and equipment.</li>
	<li>Extract the data from temporary folders on the scanner system for offline analysis. Perform log-out procedures.</li>
</ol>

None of the authors have conflicts of interest to disclose.

Critical steps 
The pre-testing of a subject&#39;s ability to generate at least minimal motion of the foot pedal with their paretic foot is crucial. An FAC score of 4 or 5 and the ability to stand for a minimal period reflect a subject&#39;s combined ability between their unaffected and paretic limbs and do not reflect the ability to move the paretic foot alone. In the current study, a primary goal was the stimulation of neuroplastic changes about the region of the injury through intensive therapy i...

The use of quantitative metrics derived from functional and structural brain imaging may be more useful and effective for tracking progress and predicting the outcomes of stroke therapy than assessing clinical scores, and these quantitative metrics could be useful in designing and improving individualized therapy plans1,2. Developing effective, personalized strategies that relate motor training to a measurable reorganization of neural activity and/or improvements in motor function remains challenging. In prior work, insights have been developed regarding how functional neuroimaging methods and brain mapping in patients affected by chronic stroke can show such changes3,4,5,6,7,8. The examination of brain function in relation to hand-grip performance (which is key to patient self-sufficiency and quality of life) has led to the expectation that this technique could also be applied to gait-related foot motion control through the evaluation of the corresponding topographic patterns of neural activity and the recovery of function. It has been posited that the incorporation of MRI-based functional maps of injury may help to characterize neurological deficits more precisely than clinical evaluations9 and that using robotic devices is more effective for brain recovery than conventional paradigms10. Functional maps can provide insight into which parts of a system are functioning, thereby providing information that is not evident from clinical observations11. Success in foot motion and strength rehabilitation with MRI for stroke patients will facilitate the development of personalized treatment strategies based on MRI metrics for a broader population with other neurological conditions.
In the work presented here, the use of the MR-compatible foot-induced robotic device (MR_COFID or foot device) during fMRI scanning is described to examine the effects of post-stroke motor skill training on brain function. The motivation for the development of this controlled-resistance foot device was the critical unmet need for foot-motion rehabilitation in stroke patients. Constructing a system suitable both for home- and office-based training and for the MR-based monitoring of the responses to training activities creates a unified approach that addresses prior limitations in terms of both training and evaluation.
The MR_COFID (Figure 1A) is an adaptation of the prior magnetic resonance-compatible hand-induced robotic device (MR_CHIRODv2)8,12, which employed an electro-rheological fluid (ERF) actuator to provide dynamically controlled, resistive force in response to a subject grasping and squeezing its handle mechanism. The ERF actuator (Figure 1B) is a fluid-filled, bi-directional piston in which the ERF on one side of the piston is forced by piston motion to flow between a pair of electrodes in a channel, which returns the fluid to the other side of the piston. When a high voltage (HV) is applied to the electrodes, particles in the non-conductive, silicone oil align and mechanically bind to each other, thus increasing the viscosity of the fluid and the device&#39;s resistance to motion. In the hand-grip device, the actuator is directly coupled to the grip handles, to a load cell to measure the applied force, and to an optical encoder to measure the displacement of the handle. The new foot device transforms the linear action of the grip device into the angular displacement of the foot in dorsiflexion and plantar flexion using a crank slider mechanism (Figure 1C). The resistance force from the ERF actuator is converted nearly in proportion to the resistance torque about the ankle joint. The pedal&#39;s crank motion is symmetrical about the vector perpendicular to the main actuator axis, thus taking advantage of the approximation that the crank angle and its sine are nearly equal for small angles. As only resistive forces can be exerted by ERF, the system is inherently safe; the actuator cannot actively push or pull the foot, and the force falls to zero when the subject stops moving. The maximum plantar flexion of the foot device is 35&#176;&#160;and the maximum dorsiflexion is 18&#176;. These values are within the range of motion of the foot during normal gait and non-weight-bearing conditions13,14, are nearly the same as the values used in other research15, and were found during preliminary testing to meet or exceed the stroke subjects&#39; ranges of motion on their injury-affected side and to allow for the maximization of the available resistive forces via the linear-angular transmission mechanism. The original grip device and the additional foot motion mechanism were constructed from non-ferrous materials (plastic, aluminum, brass) for MR safety.
The ERF actuator employs variable electrical, rather than magnetic, fields to alter the fluid viscosity and is, thus, unaffected by the magnetic fields of the MR scanner. The ERF actuator is enclosed within a cylindrical copper shell that is connected to the shield conductor of the coaxial HV cable; this cable is, in turn, grounded to the penetration panel of the MR scanner&#39;s Faraday cage. This prevents potential radio frequency noise from the variable voltage applied to the actuator from affecting the scanner and prevents the variable magnetic fields of the scanner from inducing currents in the cables, which could change the ERF viscosity. The HV cable continues outside of the penetration panel to the HV amplifier. Coaxial MHV (miniature high voltage) connectors are used, which provide additional safety when carrying voltages up to 4 kV (Figure 2).
The separate cables from the optical encoder and the load cell have shields that are also grounded to the penetration panel, thus preventing their signals (particularly the digital signals from the encoder channels) from affecting either the scanner or the small voltage load cell output. The shielded and grounded cables outside the penetration panel carry signals to the data acquisition (DAQ) module. The output of the load cell, which uses a temperature-compensated Wheatstone bridge, is amplified by an instrumentation amplifier attached to the analog input terminals of the DAQ, providing a 1,000x amplification factor.
The DAQ module runs firmware using the Lua scripting language (Supplemental Coding File 1). The script loaded onto the DAQ module runs at a loop rate of 500 Hz, and the module reads the encoder and amplified load cell signal, converts the sensor readings to length and force values, and stores them in memory registers for access and logging by an m-file user interface (UI; Figure 3) on the host laptop (Supplemental Coding File 2). The host laptop sends target force values for dorsiflexion and plantar flexion, closed-loop controller parameters, and encoder-reset commands to additional memory registers on the DAQ module when needed. The DAQ script runs a control loop that detects the pedal motion direction to determine which force to exert: dorsiflexion or plantar flexion. It then calculates an output voltage proportional to the difference between the measured and target force values, bounded by 0 V and 4 V, which is the allowable input range of the HV amplifier. The ERF responds to the magnitude of the applied electric field; reversing the voltage does not reduce the viscosity below that of the unenergized (no electric field) fluid, so the DAQ output is limited to a minimum of 0 V. The DAQ quantizes (12 bit resolution) and samples (500 Hz) the analog voltages, resulting in a stair-step output to the HV amplifier that can cause high-frequency components in the HV output due to the rapid changes at each step. The HV amplifier has small and large signal bandwidths of 35 kHz and 8 kHz, respectively, so to reduce the possibility that RF noise&#160;detectable by the scanner is generated, the DAQ output uses a first-order RC filter with a &#8722;3 dB frequency at approximately 900 Hz, so higher frequencies are almost eliminated. In addition, the foot device is positioned outside the bore of the scanner near the foot of the bed, further minimizing any interaction between the device sensors, the actuator, and the scanner. The amplifier, with a gain of 1,000 V/V and a peak output of 4 kV, generates fields across the ERF gap up to 4 kV/mm; although ERF fluid&#39;s breakdown voltage is not reported by the vendor, viscosity and other parameters are described up to this level. The ERF cylinder can exert slightly more than 200 N of force when fully energized and being moved at the target speed. The moment arm length where the connecting rod joins the pedal is 56 mm, resulting in a maximum torque of approximately 11.2 Nm. This is more than sufficient for subjects with foot paresis; however, it can be overpowered by strong, healthy subjects. The hardware components are listed in the Table of Materials.
The use of the foot device builds on the training and testing paradigms developed with earlier hand-grip devices3,4,5,6,7,8,16 and other work11,17,18. At the time of publication, this device was used with chronic stroke subjects with foot-related deficits to study therapy-driven neuroplastic changes via both MR imaging and quantitative performance evaluations.
As described in the protocol below, the subjects undergoing scanning lie supine on the scanner bed, and their heads are immobilized within the scanner&#39;s head coil and positioned at the isocenter of the scanner. The foot device is positioned and locked in place such that the subject&#39;s tested leg is straight, and their foot is strapped into the device&#39;s corresponding pedal. In this manner, bending at the ankle does not cause pushing or pulling against the device, which could shift the head&#39;s position within the coil. A mirror frame is positioned in front of the subject&#39;s eyes, allowing them to view a projection screen that displays instructions and visual cues for the motor task.
During the task, the subject views either a &#34;+&#34; sign during rest periods or a visual metronome during testing, in which one circle moves up and down on the screen (target), and another circle is displayed that moves under the control of the device&#39;s foot pedal position (cursor; Figure 4). Subjects are asked to closely follow the motion of the target. The target speed is determined so that the unenergized viscous reaction force of the device (the viscous forces increase with increasing speed) is low enough for any subject to overcome it, with increased forces applied under computer control.
Robotics are easily deployed, applicable across various motor impairments, have high measurement reliability, and have the capacity to deliver high-intensity training10. This ERF-based device delivers digitally controlled resistance force to the subject, and this device is MR-safe when coupled with non-ferrous/non-magnetic components, as well as MR-compatible due to the use of grounded and shielded electronics12. It has advantages relative to related devices in that it is portable and relatively simple to use, meaning it can be used both in clinical environments and at home, where regular therapy can be performed without the costs related to travel or the clinical facility. The device can produce computer-controlled, time-varying resistance in plantar flexion and dorsiflexion to facilitate the creation of patient-specific rehabilitation routines and, thus, addresses a gap in the field of commercially available rehabilitation devices.
Other research devices do exist but were unsuitable for the present research for various reasons. Some devices are static, measuring forces applied isometrically19 rather than over the subject&#39;s range of motion (RoM). Elastic-based devices apply increasing force with increasing displacement, rather than constant resistance over the RoM, and must be manually adjusted to change the force levels20,21,22. The use of fixed weights and gravitational loading15,23 does not allow for the computerized control of the loads or different loads for plantar flexion and dorsiflexion. Pneumatic devices24,25,26 allow for force variations between tests and a constant force across the RoM; however, the valves would need to be placed at a distance from the scanner, so generally, this device would not be able to switch between plantar flexion and dorsiflexion forces quickly when changing the foot direction and would not have the frequency response capabilities of ERF actuators. Electromagnetic motors can be used27 in the scanner environment but only by extending the mechanism far enough to maintain MR safety and compatibility, which limits the portability and increases the risk of accidents should any of the motor components be brought too close to the bore. Hydraulics28 can be bidirectional at different force levels but have challenges similar to the use of electromagnetic motors in that the compressor/driver (typically not MR-compatible) must be distant from the bore, thus limiting portability and frequency response. Hydraulics have been combined with ERF systems29 so that the system can back-drive the end effector (foot or grip device) and provide isometric resistance; however, this capability was not required for the present research and was added at the cost of using non-MR-compatible hydraulic motors.
The foot device provides a combination of features that enable the following: precise and consistent therapeutic foot-control exercises for extended periods; the measurement of the subject&#39;s current motor performance capability and adjustment of the task difficulty as rehabilitation proceeds; real-time control and independent adjustment of the applied force in both plantar flexion and dorsiflexion; remote control and adjustment of the resistance force without interruptions for manual adjustment; and MR safety and compatibility.

<table><tbody><tr><td>3T MRI scanner</td><td>Siemens Medical Solutions USA, Inc., Malvern, PA</td><td>Magnetom Skyra</td><td>https://www.siemens-healthineers.com/en-us/magnetic-resonance-imaging/3t-mri-scanner/magnetom-skyra</td></tr><tr><td>Data acquisition unit (DAQ)&amp;nbsp;</td><td>LabJack Corp., Lakewood, CO</td><td>T4</td><td>https://labjack.com/news/labjack-t4</td></tr><tr><td>High voltage amplifier&amp;nbsp;</td><td>Trek, Inc., Lockport, NY</td><td>Model 609C-6</td><td>https://www.manualsdir.com/manuals/268654/trek-609e-6-high-voltage-power-amplifier.html?page=2&amp;amp;original=1</td></tr><tr><td>Matlab</td><td>The Mathworks, Ltd., Natick, MA</td><td>n/a</td><td>https://www.mathworks.com/</td></tr><tr><td>USB repeater cable</td><td>Tripp Lite, Chicago, IL</td><td>U026-10M</td><td>https://assets.tripplite.com/product-pdfs/en/u02610m.pdf</td></tr></tbody></table>

use of a foot-induced digitally controlled resistance device for functional magnetic resonance imaging evaluation in patients with foot paresis

Use of a Foot-Induced Digitally Controlled Resistance Device for Functional Magnetic Resonance Imaging Evaluation in Patients with Foot Paresis

Neurological deficits from a stroke can result in long-term motor disabilities, including those that affect walking gait. However, extensive rehabilitation following stroke is typically time limited. Establishing predictive biomarkers to identify patients who may meaningfully benefit from additional physical therapy and demonstrate improvement is important to improve the patients&#39; quality of life. Detection of neuroplastic remodeling of the affected region and changes in the activity patterns excited while performing suitable motor tasks could have valuable implications for chronic stroke recovery. This protocol describes the use of a digitally controlled, magnetic resonance-compatible foot-induced robotic device (MR_COFID) to present a personalized foot-motor task involving trajectory following to stroke-affected subjects with gait impairment during functional magnetic resonance imaging (fMRI). In the task, foot flexion is performed against bi-directional resistive forces, which are tuned to the subject&#39;s strength in both the dorsiflexion and plantar flexion directions, while following a visual metronome. fMRI non-invasively uses endogenous deoxyhemoglobin as a contrast agent to detect blood oxygenation level-dependent (BOLD) changes between the active and resting periods during testing. Repeated periodic testing can detect therapy-related changes in excitation patterns during task performance. The use of this technique provides data to identify and measure biomarkers that may indicate the likelihood of an individual benefitting from rehabilitation beyond that which is currently provided to stroke patients.

The results described here relate to the MR compatibility of the foot device, an analysis of typical functional scan results, and notes on the foot device.
The foot device was evaluated for MR safety by the staff of the Athinoula A. Martinos Center and tested for MR compatibility in a 3 T MRI scanner. For phantom tests using a cylinder containing a solution of 1.24 g of NiSO4·6H2O and 2.62 g of NaCl per 1,000 g of H2O, the foot device was attached to the scanne...

Chronic stroke patients' insured rehabilitation is generally time limited. Imaging-based study of brain activity from walking-related motor tasks can lead to establishing biomarkers to measure improved outcomes and justify extending tailored therapy. A novel, magnetic resonance-compatible, variable-resistance foot motion device and a protocol for use during functional magnetic resonance imaging are presented.

Neurological deficits from a stroke can result in long-term motor disabilities, including those that affect walking gait. However, extensive ...

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JoVE Journal

Neuroscience

Neural-machine interfaces (NMI) have been developed to identify the user's locomotion mode. These NMIs are potentially useful for neural control of powered artificial legs, but have not been fully demonstrated. This paper presented (1) our designed engineering platform for easy implementation and development of neural control for powered lower limb prostheses and (2) an experimental setup and protocol in a laboratory environment to evaluate neurally-controlled artificial legs on patients with...

Engineering Platform and Experimental Protocol for Design and Evaluation of a Neurally-controlled Powered Transfemoral Prosthesis

A novel low-cost human-machine interface for interactive post-stroke balance rehabilitation system is presented in this article. The system integrates off-the-shelf low-cost sensors towards volitionally driven electrotherapy paradigm. The proof-of-concept software interface is demonstrated on healthy volunteers.

A Human-machine-interface Integrating Low-cost Sensors with a Neuromuscular Electrical Stimulation System for Post-stroke Balance Rehabilitation

We present a protocol to assess changes in neuromuscular function. Percutaneous electrical nerve stimulation is a non-invasive method that evokes muscular responses. Electrophysiological and mechanical properties of these responses permit the evaluation of neuromuscular function from brain to muscle (supra-spinal, spinal and peripheral levels).

Assessment of Neuromuscular Function Using Percutaneous Electrical Nerve Stimulation

Measurement of rodent skeletal muscle contractile function is a useful tool that can be used to track disease progression as well as efficacy of therapeutic intervention. We describe here the non-invasive, in vivo assessment of the dorsiflexor muscles that can be repeated over time in the same mouse.

Non-invasive Assessment of Dorsiflexor Muscle Function in Mice

We present a novel combined behavioral and neuroimaging protocol employing real-time video projection for the purpose of characterizing the neural correlates associated with mirror therapy within the magnetic resonance imaging scanner environment in leg amputee subjects with phantom limb pain.

Real-time Video Projection in an MRI for Characterization of Neural Correlates Associated with Mirror Therapy for Phantom Limb Pain

The present protocol describes the simultaneous, bilateral assessment of the corticomotor response of the tibialis anterior and soleus during rest and tonic voluntary activation using a single pulse transcranial magnetic stimulation and neuronavigation system.

Bilateral Assessment of the Corticospinal Pathways of the Ankle Muscles Using Navigated Transcranial Magnetic Stimulation

We performed functional MRI using a novel MRI-compatible hand-induced robotic device to evaluate its utility for monitoring hand motor function in individuals recovering from neurological deficits.

Functional MRI in Conjunction with a Novel MRI-compatible Hand-induced Robotic Device to Evaluate Rehabilitation of Individuals Recovering from Hand Grip Deficits

This protocol describes the process for performing a neurophysiological assessment of the lower extremity muscles, tibialis anterior and soleus, in a standing position using TMS in people post-stroke. This position provides a greater probability of eliciting a post-stroke TMS response and allows for the use of reduced stimulator power during neurophysiological assessments.

Standing Neurophysiological Assessment of Lower Extremity Muscles Post-Stroke

The functional core stability of the foot contributes to the human static posture and dynamic activities. This paper proposes a comprehensive evaluation for the function of the foot core system, which combines three subsystems. It may provide increased awareness and multifaceted protocol to explore the foot function among different populations.

Evaluating the Function of the Foot Core System in the Elderly

Here, we investigate the effect of functional occupational therapy combined with assisted active or passive motion on the upper limb function of patients with right hemisphere damage and explore the effect of functional near-infrared spectroscopy on brain function remodeling.

Investigating the Effect of Different Types of Exercise on Upper Limb Functional Recovery in Patients with Right Hemisphere Damage Based on fNIRS

It is estimated that 1 in 6 individuals worldwide will have a stroke in their lifetime, causing long-term disability, whose rehabilitation mechanisms are still poorly understood. This study proposes a protocol to evaluate brain activation by functional near-infrared spectroscopy (fNIRS) during a lower limb robotic therapy session.

An Experiment Using Functional Near-Infrared Spectroscopy and Robot-Assisted Multi-Joint Pointing Movements of the Lower Limb

Learn a novel MRI-compatible foot motion device for evaluating brain activity during walking tasks in chronic stroke patients. This method establishes biomarkers to justify extended rehabilitation therapy and assess outcomes.

Use of a Foot-Induced Digitally Controlled Resistance Device for Functional Magnetic Resonance Imaging Evaluation in Patients with Foot Paresis (Video) | JoVE Journal

Use of a Foot-Induced Digitally Controlled Resistance Device for Functional Magnetic Resonance Imaging Evaluation in Patients with Foot Paresis

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