Name: Application of Bedside Lower Extremity Rehabilitation Robots in Stroke Rehabilitation: A Randomized Controlled Trial (Video) | JoVE Journal
Uploaded: 2025-11-28T14:10:00.000+00:00
Duration: 4 min 38 s
Description: Learn bedside lower limb rehabilitation robotics for stroke recovery using a randomized controlled trial protocol. This method compares robot-assisted therapy to manual therapy for motor function and patient comfort outcomes.

ai_agent_IP

ai_agent

maintenance

instantTrialDurationMinutes

isBiopharma

enableNewMyJoveSectionDesign

educationFeatures

seoMetaApi

ai_copilot_institution_blacklist

ai_chat_institution_blacklist

freeAccessWindow

ssoRoleCapture

scheduledMaintenanceBanner

joveLabsFeatures

disable_autoplay_for_bots

extended_trial_duration

5 minutes

This work was supported by Zhejiang Provincial &#8220;Top Soldier&#8221; and &#8220;Leading Wild Goose&#34; Program (2023C03101). We wish to acknowledge the relevant participants.

The study recruited 40 patients with lower limb dysfunction who were admitted to the rehabilitation ward of the First Affiliated Hospital of Zhejiang University from March to April 2024, and were randomly selected and divided into two groups. This study protocol was approved by the Ethics Committee of the First Affiliated Hospital of Zhejiang University (approval number IIT20210035C-R2), and informed consent was obtained from all participants.
NOTE: Patients diagnosed with their first onset of stroke based on cranial CT or MRI, and had lower limb muscle strength &#8804; grade 2 were included in the study. Patients in poor general condition, with unstable medical status, or with unstable vital signs, and patients unable to complete the study due to various reasons were excluded.
1. Study design
<ol>
	<li>Randomization and blinding
	<ol>
		<li>Randomization:
		<ol>
			<li>Generate a random sequence using SAS software (version 9.4) with a fixed seed (SEED = 12345) to assign 40 patients equally to control or observation groups (n = 20 each).</li>
			<li>Ensure allocation concealment by using sequentially numbered, opaque, sealed envelopes prepared by an independent statistician not involved in patient recruitment or assessment. Each envelope contained the group assignment. Open each envelope only after the participant meets eligibility criteria and provides informed consent.</li>
		</ol>
		</li>
		<li>Blinding:
		<ol>
			<li>Due to the nature of the intervention (robot-assisted vs. manual therapy), participants and therapists could not be blinded. However, blind the outcome assessors to group assignments to minimize detection bias.</li>
		</ol>
		</li>
	</ol>
	</li>
	<li>Observation indicators and evaluation criteria
	<ol>
		<li>General Comfort Questionnaire (GCQ)
		<ol>
			<li>Administer the 28-item General Comfort Questionnaire (GCQ) (Likert scale 1-4) in a quiet, private room (&#8804;40 dB ambient noise) before and after phase 1 treatment. 
			NOTE: The scale evaluates three domains: physical comfort (items 1-12, e.g., &#34;I feel no pain when moving&#34;), psychological comfort (items 13-20, e.g., &#34;I feel calm during therapy&#34;), and environmental comfort (items 21-28, e.g., &#34;The room temperature is comfortable&#34;).</li>
			<li>Instruct patients to complete all items independently; discard questionnaires with &#60;80% response rate and re-administer within 24 h, if necessary. 
			NOTE: Ensure a quiet environment during assessment; discard incomplete responses (&#60;80% items answered).</li>
		</ol>
		</li>
		<li>Fugl-Meyer assessment for lower extremities (FMA-LE)
		<ol>
			<li>Conduct the FMA-LE (0-34 points) at three timepoints: pre-treatment, post-phase 1 (week 2), and post-phase 2 (week 4) . Follow standardized scoring:</li>
			<li>Reflex activity (items 1-2): Grade ankle plantarflexion and knee extensor reflexes (0 = absent, 1 = hypoactive, 2 = normal).</li>
			<li>Voluntary movement (items 3-34): Score hip/knee/ankle movements hierarchically (0 = no movement, 1 = partial movement, 2 = full movement).</li>
			<li>Video-record all assessments using a 4K camera (60 fps) for blinded review by two independent raters, with discrepancies resolved via consensus.</li>
		</ol>
		</li>
		<li>Modified Ashworth scale (MAS)
		<ol>
			<li>Assess quadriceps spasticity (0-5 scale) pre- and post-phase 2 using a standardized protocol as follows:</li>
			<li>Position the patient supine with the knee flexed at 90&#176;.</li>
			<li>Passively move the ankle through full dorsiflexion-plantarflexion at a 1 s cycle.</li>
			<li>Grade resistance during stretch: 0 = no resistance, 1 = slight resistance (catch), 2 = mild resistance (easily overcome), 3 = moderate resistance (requires effort), 4 = severe resistance (difficult to move), 5 = rigid.</li>
			<li>Perform 3 trials and use the mean score if the variability exceeds 1 grade.</li>
		</ol>
		</li>
		<li>Modified Barthel Index (MBI)
		<ol>
			<li>Score 10 activities of daily living (ADLs) (e.g., feeding, grooming, walking) using the MBI (0-100 scale) before and after phase 2 treatment.</li>
			<li>For patients with cognitive impairment (MMSE &#60; 18), interview primary caregivers to verify ADL performance (e.g., &#34;Can the patient dress independently?&#34;). Higher scores indicate greater independence in daily activities.</li>
		</ol>
		</li>
	</ol>
	</li>
</ol>
2. Intervention protocols
<ol>
	<li>Control group (Conventional manual therapy)
	<ol>
		<li>Phase 1 (Weeks 1-2): Therapist-led passive training
		<ol>
			<li>Perform passive range-of-motion exercises (hip/knee flexion-extension, ankle dorsiflexion) for 20 min/day. Maintain joint angles within safe limits (hip &#8804; 90&#176;, knee &#8804; 120&#176;).</li>
		</ol>
		</li>
		<li>Phase 2 (Weeks 3-4): Therapist-led active training
		<ol>
			<li>Guide active resistance training using elastic bands with 20-30 N resistance. The training includes hip abduction-adduction, knee extension-flexion, and ankle dorsiflexion-plantarflexion, with 20 min/day.</li>
		</ol>
		</li>
		<li>Ensure the patient maintains a stable sitting position during training and avoids compensatory movements of the trunk. Terminate session if pain VAS &#62;3/10 or blood pressure &#62;160/100 mmHg.</li>
	</ol>
	</li>
	<li>Observation group (Robot-assisted therapy)
	<ol>
		<li>Device settings: Set the following parameters: 
		Speed: Set to 15&#176;/s (phase 1) or 20&#176;/s (phase 2). 
		Torque Limit: 30 Nm (hip/knee), 15 Nm (ankle). 
		ROM Limits: Hip 0-90&#176;, knee 0-120&#176;, ankle -10&#176; to +20&#176;.</li>
		<li>Phase 1 (Weeks 1-2): Robot-assisted passive training
		<ol>
			<li>Secure the patient in the supine position with 30&#176; head elevation. Initiate passive mode; monitor electromyography (EMG) for spasm detection (&#62;50 &#181;V/100 ms triggers auto-pause).</li>
		</ol>
		</li>
		<li>Phase 2 (Weeks 3-4): Combine 20-min therapist-led active training with 20-min robot-assisted passive training 
		NOTE: Calibrate force sensors before each session; recalibrate if drift &#62; 5%.</li>
	</ol>
	</li>
</ol>
3. Robot operation protocol
<ol>
	<li>Bedside consultation
	<ol>
		<li>Conduct a comprehensive clinical assessment of the patient, including vital sign monitoring (blood pressure, heart rate, SpO2) to confirm stability; neurological examination to evaluate limb muscle strength (FMA-LE); skin condition inspection to exclude lesions at brace contact sites; functional assessment to determine the patient&#39;s ability to cooperate with training (using the Mini-Mental State Examination, MMSE).</li>
		<li>Provide functional evaluation and rehabilitation recommendations.</li>
		<li>Exclude patients with skin lesions at brace contact sites. 
		NOTE: This step is performed by a rehabilitation physician before treatment begins.</li>
	</ol>
	</li>
	<li>Brace installation
	<ol>
		<li>Position the patient in a supine, lateral, or prone position as needed. 
		NOTE: Maintain supine position with 30&#176; head elevation for &#8804;60 min; reposition if SpO2 drops &#62; 5% from baseline.</li>
		<li>Inspect the patient&#39;s lower limb to ensure it is suitable for bracing.</li>
		<li>Inform the patient about the training procedures.</li>
		<li>Install the brace on the patient&#39;s lower limb.
		<ol>
			<li>Align brace connectors (marked with an upward arrow) with joint axes.</li>
			<li>Tighten straps to 2-finger tightness (5-7 N tension).</li>
			<li>Confirm no skin pinching or excessive pressure (&#62;30 mmHg via pressure film). 
			NOTE: Proper alignment and comfort should be confirmed after installation.</li>
		</ol>
		</li>
	</ol>
	</li>
	<li>Training execution
	<ol>
		<li>Passive mode: Select Pre-programmed Trajectory 1 for flexion-extension cycles (10 reps/set). Patients in Phase 1 (Weeks 1-2) of the observation group undergo 20 min of passive mode training daily. 
		NOTE: If joint misalignment occurs, reposition the brace and restart.</li>
		<li>Assistive mode: Set assistance level to 50% of the patient&#39;s maximum voluntary contraction (MVC). Patients in Phase 2 (Weeks 3-4) of the observation group undergo 20 min of assistive mode training daily, combined with 20 min of therapist-led active training. 
		NOTE: Reassess MVC weekly using a handheld dynamometer.</li>
	</ol>
	</li>
</ol>
4. Critical practical notes
<ol>
	<li>Contraindications:
	<ol>
		<li>Exclude patients with unstable fractures (X-ray confirmation required) and exclude patients with deep vein thrombosis (D-dimer &#62;500 &#181;g/L).</li>
	</ol>
	</li>
	<li>Safety checks:
	<ol>
		<li>Test emergency stop button functionality daily and inspect cables for wear monthly.</li>
	</ol>
	</li>
	<li>Data recording:
	<ol>
		<li>Export session logs in CSV format, which should include joint angles, torque output, and spasm events.</li>
	</ol>
	</li>
</ol>

<ol><li>Campbell, B. C. V., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Ischaemic+stroke%5BTitle%5D)+AND+%22Nat+Rev+Dis+Primers%22%5BJournal%5D)">Ischaemic stroke.</a> Nat Rev Dis Primers. 5 (1), 70(2019).</li>
<li>Liao, J., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Recent+advances+in+targeted+nanotherapies+for+ischemic+stroke%5BTitle%5D)+AND+%22Mol+Pharm%22%5BJournal%5D)">Recent advances in targeted nanotherapies for ischemic stroke.</a> Mol Pharm. 19 (9), 3026-3041 (2022).</li>
<li>Gassert, R., Dietz, V. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Rehabilitation+robots+for+the+treatment+of+sensorimotor+deficits%3A+a+neurophysiological+perspective%5BTitle%5D)+AND+%22J+Neuroeng+Rehabil%22%5BJournal%5D)">Rehabilitation robots for the treatment of sensorimotor deficits: a neurophysiological perspective.</a> J Neuroeng Rehabil. 15 (1), 46(2018).</li>
<li>Lin, D. J., Finklestein, S. P., Cramer, S. C. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((New+directions+in+treatments+targeting+stroke+recovery%5BTitle%5D)+AND+%22Stroke%22%5BJournal%5D)">New directions in treatments targeting stroke recovery.</a> Stroke. 49 (12), 3107-3114 (2018).</li>
<li>Zhang, T., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Enhancing+upper+limb+function+and+motor+skills+post-stroke+through+an+upper+limb+rehabilitation+robot%5BTitle%5D)+AND+%22J+Vis+Exp%22%5BJournal%5D)">Enhancing upper limb function and motor skills post-stroke through an upper limb rehabilitation robot.</a> J Vis Exp. (211), e66938(2024).</li>
<li>Stinear, C. M., Lang, C. E., Zeiler, S., Byblow, W. D. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Advances+and+challenges+in+stroke+rehabilitation%5BTitle%5D)+AND+%22Lancet+Neurol%22%5BJournal%5D)">Advances and challenges in stroke rehabilitation.</a> Lancet Neurol. 19 (4), 348-360 (2020).</li>
<li>Yao, Z., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Cognitive+function+and+upper+limb+rehabilitation+training+post-stroke+using+a+digital+occupational+training+system%5BTitle%5D)+AND+%22J+Vis+Exp%22%5BJournal%5D)">Cognitive function and upper limb rehabilitation training post-stroke using a digital occupational training system.</a> J Vis Exp. (202), e65994(2023).</li>
<li>Kiyono, K., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Effectiveness+of+robotic+devices+for+medical+rehabilitation%3A+an+umbrella+review%5BTitle%5D)+AND+%22J+Clin+Med%22%5BJournal%5D)">Effectiveness of robotic devices for medical rehabilitation: an umbrella review.</a> J Clin Med. 13 (21), 6616(2024).</li>
<li>Effect of different training modes on ground reaction forces during robot assisted floor walking and stair climbing. Hussein, S., Schmidt, H., Hesse, S., Kruger, J. 2009 IEEE International Conference on Rehabilitation Robotics, Kyoto, Japan, , 84-850 (2009).</li>
<li>Bo, A. P. L., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Control+strategies+for+gait+tele-rehabilitation+system+based+on+parallel+robotics%5BTitle%5D)+AND+%22Appl+Sci%22%5BJournal%5D)">Control strategies for gait tele-rehabilitation system based on parallel robotics.</a> Appl Sci. 11 (23), 11095(2021).</li>
<li>Wang, Z., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Structural+design+and+research+of+a+novel+lower+limb+rehabilitation+robot+for+human-robot+coupling%5BTitle%5D)+AND+%22Int+J+Adv+Robot+Syst%22%5BJournal%5D)">Structural design and research of a novel lower limb rehabilitation robot for human-robot coupling.</a> Int J Adv Robot Syst. 21 (2), (2024).</li>
<li>Mousavi Hondori, H., Khademi, M., Dodakian, L., Cramer, S. C., Lopes, C. V. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((A+spatial+augmented+reality+rehab+system+for+post-stroke+hand+rehabilitation%5BTitle%5D)+AND+%22Stud+Health+Technol+Inform%22%5BJournal%5D)">A spatial augmented reality rehab system for post-stroke hand rehabilitation.</a> Stud Health Technol Inform. 184 (1), 279-285 (2013).</li>
<li>Zhang, L., Jia, G., Ma, J., Wang, S., Cheng, L. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Short+and+long-term+effects+of+robot-assisted+therapy+on+upper+limb+motor+function+and+activity+of+daily+living+in+patients+post-stroke%3A+a+meta-analysis+of+randomized+controlled+trials%5BTitle%5D)+AND+%22J+Neuroeng+Rehabil%22%5BJournal%5D)">Short and long-term effects of robot-assisted therapy on upper limb motor function and activity of daily living in patients post-stroke: a meta-analysis of randomized controlled trials.</a> J Neuroeng Rehabil. 19 (1), 76(2022).</li>
<li>Rakhtala, S. M., Ghayebi, R. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Real+time+control+and+fabrication+of+a+soft+robotic+glove+by+two+parallel+sensors+with+MBD+approach%5BTitle%5D)+AND+%22Med+Eng+Phys%22%5BJournal%5D)">Real time control and fabrication of a soft robotic glove by two parallel sensors with MBD approach.</a> Med Eng Phys. 100 (1), 103743(2022).</li>
<li>Kim, K. T., Choi, Y., Cho, J. H., Lee, S. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Feasibility+and+usability+of+a+robot-assisted+complex+upper+and+lower+limb+rehabilitation+system+in+patients+with+stroke%3A+a+pilot+study%5BTitle%5D)+AND+%22Ann+Rehabil+Med%22%5BJournal%5D)">Feasibility and usability of a robot-assisted complex upper and lower limb rehabilitation system in patients with stroke: a pilot study.</a> Ann Rehabil Med. 47 (2), 108-117 (2023).</li>
<li>Hu, F. Z., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((iLeg-a+lower+limb+rehabilitation+robot%3A+a+proof+of+concept%5BTitle%5D)+AND+%22IEEE+Trans+Hum+Mach+Syst%22%5BJournal%5D)">iLeg-a lower limb rehabilitation robot: a proof of concept.</a> IEEE Trans Hum Mach Syst. 46 (5), 761-768 (2016).</li>
<li>Pisla, D., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Development+of+a+control+system+and+functional+validation+of+a+parallel+robot+for+lower+limb+rehabilitation%5BTitle%5D)+AND+%22Actuators%22%5BJournal%5D)">Development of a control system and functional validation of a parallel robot for lower limb rehabilitation.</a> Actuators. 10 (10), 277(2021).</li>
<li>Wang, H., Shen, H., Han, Y., Zhou, W., Wang, J. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Effect+of+robot-assisted+training+for+lower+limb+rehabilitation+on+lower+limb+function+in+stroke+patients%3A+a+systematic+review+and+meta-analysis%5BTitle%5D)+AND+%22Front+Hum+Neurosci%22%5BJournal%5D)">Effect of robot-assisted training for lower limb rehabilitation on lower limb function in stroke patients: a systematic review and meta-analysis.</a> Front Hum Neurosci. 19 (1), 1549379(2025).</li>
<li>Xie, L., Yoon, B. H., Park, C., You, J. S. H. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Optimal+intervention+timing+for+robotic-assisted+gait+training+in+hemiplegic+stroke%5BTitle%5D)+AND+%22Brain+Sci%22%5BJournal%5D)">Optimal intervention timing for robotic-assisted gait training in hemiplegic stroke.</a> Brain Sci. 12 (8), 1058(2022).</li>
<li>Zhang, X., Yue, Z., Wang, J. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Robotics+in+lower-limb+rehabilitation+after+stroke%5BTitle%5D)+AND+%22Behav+Neurol%22%5BJournal%5D)">Robotics in lower-limb rehabilitation after stroke.</a> Behav Neurol. 2017, 3731802(2017).</li>
<li>Kolcaba, K. Y., Kolcaba, R. J. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((An+analysis+of+the+concept+of+comfort%5BTitle%5D)+AND+%22J+Adv+Nurs%22%5BJournal%5D)">An analysis of the concept of comfort.</a> J Adv Nurs. 16 (11), 1301-1310 (1991).</li>
<li>Gladstone, D. J., Danells, C. J., Black, S. E. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((The+Fugl-Meyer+assessment+of+motor+recovery+after+stroke%3A+a+critical+review+of+its+measurement+properties%5BTitle%5D)+AND+%22Neurorehabil+Neural+Repair%22%5BJournal%5D)">The Fugl-Meyer assessment of motor recovery after stroke: a critical review of its measurement properties.</a> Neurorehabil Neural Repair. 16 (3), 232-240 (2002).</li>
<li>Jm, G., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Reliability+of+the+tone+assessment+scale+and+the+modified+Ashworth+scale+as+clinical+tools+for+assessing+poststroke+spasticity%5BTitle%5D)+AND+%22Arch+Phys+Med+Rehabil%22%5BJournal%5D)">Reliability of the tone assessment scale and the modified Ashworth scale as clinical tools for assessing poststroke spasticity.</a> Arch Phys Med Rehabil. 80 (9), 1013-1016 (1999).</li>
<li>Sulter, G., Steen, C., Keyser, J. D. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Use+of+the+Barthel+Index+and+modified+Rankin+scale+in+acute+stroke+trials%5BTitle%5D)+AND+%22Stroke%22%5BJournal%5D)">Use of the Barthel Index and modified Rankin scale in acute stroke trials.</a> Stroke. 30 (8), 1538-1541 (1999).</li>
<li>Leung, S. O., Chan, C. C., Shah, S. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Development+of+a+Chinese+version+of+the+modified+Barthel+Index-validity+and+reliability%5BTitle%5D)+AND+%22Clin+Rehabil%22%5BJournal%5D)">Development of a Chinese version of the modified Barthel Index-validity and reliability.</a> Clin Rehabil. 21 (10), 912-922 (2007).</li>
<li>Bonanno, L., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Neural+plasticity+changes+induced+by+motor+robotic+rehabilitation+in+stroke+patients%3A+the+contribution+of+functional+neuroimaging%5BTitle%5D)+AND+%22Bioengineering+%28Basel%29%22%5BJournal%5D)">Neural plasticity changes induced by motor robotic rehabilitation in stroke patients: the contribution of functional neuroimaging.</a> Bioengineering (Basel). 10 (8), 990(2023).</li>
<li>Lewandowska-Sroka, P., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((The+influence+of+EMG-triggered+robotic+movement+on+walking%2C+muscle+force+and+spasticity+after+an+ischemic+stroke%5BTitle%5D)+AND+%22Medicina%22%5BJournal%5D)">The influence of EMG-triggered robotic movement on walking, muscle force and spasticity after an ischemic stroke.</a> Medicina. 57 (3), 227(2021).</li>
<li>Huo, Y., Wang, X., Zhao, W., Hu, H., Li, L. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Effects+of+EMG-based+robot+for+upper+extremity+rehabilitation+on+post-stroke+patients%3A+a+systematic+review+and+meta-analysis%5BTitle%5D)+AND+%22Front+Physiol%22%5BJournal%5D)">Effects of EMG-based robot for upper extremity rehabilitation on post-stroke patients: a systematic review and meta-analysis.</a> Front Physiol. 14, 1172958(2023).</li>
<li>von Lewinski, F., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Efficacy+of+EMG-triggered+electrical+arm+stimulation+in+chronic+hemiparetic+stroke+patients%5BTitle%5D)+AND+%22Restor+Neurol+Neurosci%22%5BJournal%5D)">Efficacy of EMG-triggered electrical arm stimulation in chronic hemiparetic stroke patients.</a> Restor Neurol Neurosci. 27 (3), 189-197 (2009).</li>
<li>Lee, K. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((EMG-triggered+pedaling+training+on+muscle+activation%2C+gait%2C+and+motor+function+for+stroke+patients%5BTitle%5D)+AND+%22Brain+Sci%22%5BJournal%5D)">EMG-triggered pedaling training on muscle activation, gait, and motor function for stroke patients.</a> Brain Sci. 12 (1), 76(2022).</li>
<li>Zhang, L., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Cognitive-motor+dual-task+training+on+gait+and+balance+in+stroke+patients%3A+meta-analytic+report+and+trial+sequential+analysis+of+randomized+clinical+trials%5BTitle%5D)+AND+%22J+Neuroeng+Rehabil%22%5BJournal%5D)">Cognitive-motor dual-task training on gait and balance in stroke patients: meta-analytic report and trial sequential analysis of randomized clinical trials.</a> J Neuroeng Rehabil. 21 (1), 227(2024).</li>
</ol>

The authors declare no conflicts of interest or financial disclosures related to this study.

The lower limb dysfunction caused by post-stroke hemiplegia has a severe impact on patients' quality of life and even their safety22,25. Conventional rehabilitation therapy is primarily performed manually by physical therapists, facing challenges such as difficulty in quantifying the treatment process and poor control over treatment intensity. As a result, it is difficult to ensure that each patient receives standardized and equivalent therapy. This protocol demo...

Stroke is a leading cause of death and long-term disability globally, with ischemic stroke accounting for 70-80% of cases1,2. The resulting cerebral hypoperfusion leads to irreversible neuronal damage, often causing permanent motor impairment that severely impacts quality of life3,4. Early rehabilitation initiation within 48 hours of symptom stabilization significantly improves functional outcomes in patients with post-stroke lower limb paralysis5. However, conventional early rehabilitation (e.g., manual passive joint mobilization) faces inherent limitations: therapist workload constraints often limit training frequency, and manual operation variability compromises treatment consistency6. These gaps are particularly pronounced during the acute bedridden phase, when patients require continuous, standardized mobility support that traditional care struggles to deliver.
Rehabilitation robotics has emerged as a solution to address these unmet needs, with growing integration into clinical practice over the past decade7. Compared with conventional therapies, rehabilitation robots reduce therapist workload and ensure treatment consistency through expert-derived algorithms, while their repetitive, task-specific training enhances neural pathway reconstruction8. Notably, bedside-specific robotic systems are uniquely tailored to the acute care context-unlike clinic-based robots that require patient transfer (a barrier for bedridden individuals), bedside devices deliver intervention directly at the patient&#39;s bed, aligning with the &#34;early mobility at bedside&#34; principle of modern stroke care. Prior studies confirm that such systems significantly improve motor function (as measured by Fugl-Meyer Assessment) and reduce spasm incidence in early stroke patients, outperforming manual therapy in standardization and safety.
Haptic-Walker9 and Bo10 et al. have proved that motor rehabilitation training of the patient&#39;s ankle was performed using a parallel robotic platform, and it was confirmed that the lower limb rehabilitation robot significantly improves both motor function and brain function in stroke patients11,12,13,14,15. As a device specifically designed to address lower limb dysfunction, the bedside lower limb rehabilitation robot can assist therapists in performing manual operations to a certain extent. In some aspects, it even surpasses manual therapy in terms of treatment standardization7, offering effective support for daily rehabilitation training and promoting the recovery of lower limb function. Bedside lower limb rehabilitation robots have proven their effectiveness and safety in the early rehabilitation of stroke patients16. A recently published work in the International Journal of Advanced Robotic Systems reported a two-link planar robot model to simulate both the robot and human lower limbs17,18. The robot allows for the flexion and extension movements of the hip, knee, and ankle joints, as well as the adduction and abduction movements of the ankle. Furthermore, the incorporation of two degrees of freedom in the ankle joint further allows the system to serve as a wearable device for ankle-specific rehabilitation, contributing to a more comprehensive and effective lower extremity rehabilitation program19,20.
This protocol focuses on a bedside lower limb rehabilitation robot capable of providing passive and assisted movements with built-in safety features, including spasm detection. The system allows customization of parameters such as speed, torque, and session duration to meet individual needs. The primary objective is to investigate the clinical value of lower limb rehabilitation robots in the treatment of post-stroke hemiplegia, with particular attention to their practical efficacy and patient comfort, in order to provide a reference for their broader clinical application.

<table><tbody><tr><td>Bedside Lower Limb Rehabilitation Training System, Model: LR-H01-L10</td><td>Suzhou Kanglian Medical Technology Co., Ltd.</td><td>LR-H01-L10</td><td>Robotic device for passive and assisted lower limb movement in post-stroke rehabilitation</td></tr><tr><td>SAS software</td><td>SAS Institute</td><td>version 9.4</td><td>https://www.sas.com/en_in/home .html</td></tr><tr><td>SPSS software</td><td>IBM</td><td>version 31</td><td>https://www.ibm.com/products/spss-statistics</td></tr></tbody></table>

application of bedside lower extremity rehabilitation robots in stroke rehabilitation: a randomized controlled trial

Application of Bedside Lower Extremity Rehabilitation Robots in Stroke Rehabilitation: A Randomized Controlled Trial

Stroke remains one of the leading causes of disability worldwide. Bedside lower limb rehabilitation robots are increasingly applied to enhance early motor recovery. This randomized controlled trial compared the clinical efficacy and patient comfort of robot-assisted therapy versus conventional manual therapy in post-stroke hemiplegia. Forty inpatients with first-onset stroke and lower limb muscle strength &#8804; grade 2 were randomly allocated (1:1) to a robot-assisted therapy group or a conventional manual therapy group using SAS 9.4 (SEED = 12345). This randomized controlled trial compared the clinical efficacy and patient comfort of robot-assisted therapy versus conventional manual therapy in post-stroke hemiplegia, with primary outcomes including the General Comfort Questionnaire (GCQ), Fugl-Meyer Assessment for lower extremities (FMA-LE), Modified Ashworth Scale (MAS), and Modified Barthel Index (MBI). Robot-assisted therapy achieved similar early motor gains, superior comfort scores, and greater later functional improvements compared to conventional manual therapy. Integrating bedside rehabilitation robots into early stroke care is feasible, safe, and may enhance patient experience and functional recovery. This protocol describes a two-stage intervention design, where the robot-assisted group received a combination of robot training and artificial therapy in the later stage.

This study adopted a randomized controlled trial design, where 40 participants were randomly assigned to either an observation group (robot-assisted therapy) or a control group (conventional manual therapy) using SAS software. The treatment plans of the two groups were as follows:
For the control group, patients received manual therapy targeting lower limb dysfunction, administered by a physical therapist once daily for 20 min per session. The treatment was divided into two phases: phase 1 (we...

This protocol aims to evaluate the clinical efficacy and patient comfort of using bedside lower limb rehabilitation robots for post-stroke hemiplegia rehabilitation, comparing outcomes with those of traditional manual therapy through randomized controlled trials.

Stroke remains one of the leading causes of disability worldwide. Bedside lower limb rehabilitation robots are increasingly applied to enhance early motor ...

This research focuses on bedside lower limb rehab robots for stroke and assess effects and comfort. To begin, position a control group patient with a first-onset stroke and lower limb dysfunction comfortably on the treatment table. Perform passive range-of-motion exercises of the patient's lower limb, including hip and knee flexion extension, and ankle dorsiflexion for 20 minutes per day for two weeks, while maintaining safe joint limits.For weeks three and four, guide the patient through active resistance training using elastic bands that provide 20 to 30 Newtons of resistance. Instruct the patient to perform ankle dorsiflexion, plantar flexion, hip abduction adduction, and knee extension flexion for 20 minutes per day. Set up the bedside lower limb rehabilitation robot and confirm the phase-specific parameters for robot-assisted therapy.Position the patient with first-onset stroke and lower limb dysfunction assigned to the therapy group in a supine, lateral, or prone position, as needed. Using visual inspection, examine the patient's lower limb to confirm it is suitable for bracing. Inform the patient about the training procedures before installing the brace on the patient's lower limb.Align the brace connectors marked with an upward arrow with the joint axes, and tighten the straps to a two-finger tightness that corresponds to five to seven Newton tension, ensuring no skin pinching or excessive pressure. Ensure proper alignment and comfort after installation. In the passive mode, select preprogrammed trajectory 1 to perform flexion-extension cycles at 10 repetitions per set.During weeks one and two, conduct 20 minutes of passive robot-assisted training daily. If joint misalignment occurs, pause the session, reposition the brace, and restart the training. For the next phase, set the assistance level to 50%of the patient's maximum voluntary contraction.During weeks three and four, conduct 20 minutes of robot-guided assistive training daily, combined with 20 minutes of therapist-led active training. Finally, stop the session and export the session logs. Before training, general comfort questionnaire scores were comparable between the two groups.After phase one, the observation group showed significantly higher scores than the control group, and this difference persisted after phase two. Only the observation group showed a statistically significant increase in comfort level after the second phase of training. Following phase two, the observation group had a significantly higher score for lower limb motor recovery than the control group.Modified Barthel Index scores increased significantly in both groups after training, with the observation group scoring significantly higher than the control group. This protocol addresses workload and consistency issues in traditional stroke rehabilitation through the use of bedside robots. Our future research will focus on larger multicenter trials, matching the training, the rotation, and the biomechanical assessments.

application-bedside-lower-extremity-rehabilitation-robots-stroke

Research

JoVE Journal

Medicine

We developed a real-time mirror robot system for functional recovery of hemiplegic arms using automatic control technology, conducted a clinical study on healthy subjects, and determined tasks through feedback from rehabilitation doctors. This simple mirror robot can be applied effectively to occupational therapy in stroke patients with a hemiplegic arm.

Robotic Mirror Therapy System for Functional Recovery of Hemiplegic Arms

The combined use of transcranial direct current stimulation and robotic therapy as an add-on for conventional rehabilitation therapy may result in improved therapeutic outcomes due to modulation of brain plasticity. In this article, we describe the combined methods used in our institute for improving motor performance after stroke.

The Combined Use of Transcranial Direct Current Stimulation and Robotic Therapy for the Upper Limb

The current protocol outlines how the VR-based digital occupational training system enhances the rehabilitation of patients with cognitive impairment and upper limb dysfunction following a stroke.

Cognitive Function and Upper Limb Rehabilitation Training Post-Stroke Using a Digital Occupational Training System

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

This protocol describes an upper limb rehabilitation robot that provides intelligent feedback through four modes. These modes enhance upper limb function and flexibility, thereby improving patients' quality of life.

Enhancing Upper Limb Function and Motor Skills Post-Stroke Through an Upper Limb Rehabilitation Robot

This experimental protocol outlines the use of a dual upper limb task-oriented robotic system for stroke patients with upper limb dysfunction. The findings indicate that this system can significantly improve stroke patients' upper limb function and daily living activities.

Application of a Dual Upper Limb Task-Oriented Robotic System for the Functional Recovery of the Upper Limb in Stroke Patients

The efficacy of combining exoskeleton-assisted, body weight-supported treadmill training with game-based virtual reality on dual-task capability in stroke survivors has yet to be studied. Therefore, this rehabilitation program aims to investigate the potential functions and advantages of this combination in enhancing walking capability during stroke recovery.

A Rehabilitation Program of Exoskeleton-assisted Body Weight-Supported Treadmill Training with Non-immersive Virtual Reality for Stroke Patients

This study introduces a brain-computer interface (BCI) system for stroke patients, which combines electroencephalography and electrooculography signals to control an upper limb robotic hand, enhancing daily activities. The evaluation used the Berlin Bimanual Test for Stroke (BeBiTS).

Brain-Computer Interface-controlled Upper Limb Robotic System for Enhancing Daily Activities in Stroke Patients

Survivors of acute respiratory distress syndrome (ARDS) and critical illness frequently develop long-lasting muscle weakness. Manual muscle testing (MMT) is a standardized clinical examination commonly used to measure strength of peripheral skeletal muscle groups.  This video demonstrates MMT using the 6-point  Medical Research Council scale.

Manual Muscle Testing:  A Method of Measuring Extremity Muscle Strength Applied to Critically Ill Patients 

The purpose is to present a new method, breathing-control electrical stimulation (BreEStim) for management of neuropathic pain and spasticity.

Breathing-controlled Electrical Stimulation (BreEStim) for Management of Neuropathic Pain and Spasticity

Learn bedside lower limb rehabilitation robotics for stroke recovery using a randomized controlled trial protocol. This method compares robot-assisted therapy to manual therapy for motor function and patient comfort outcomes.

Application of Bedside Lower Extremity Rehabilitation Robots in Stroke Rehabilitation: A Randomized Controlled Trial

Explore More Videos