Application of Bedside Lower Extremity Rehabilitation Robots in Stroke Rehabilitation: A Randomized Controlled Trial
November 28th, 2025
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.
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.
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Overview
This randomized controlled trial evaluates the clinical efficacy and patient comfort of bedside lower limb rehabilitation robots compared to conventional manual therapy in patients with post-stroke hemiplegia. The study involves a two-stage intervention protocol, assessing both early motor recovery and patient-reported comfort outcomes.
Key Study Components
Area of Science
- Stroke rehabilitation
- Physical therapy
- Robotics in medicine
Background
- Stroke is a leading cause of disability worldwide.
- Early motor rehabilitation is critical for functional recovery after stroke.
- Bedside rehabilitation robots are increasingly used to address workload and consistency challenges in traditional therapy.
- Comparative data on patient comfort and efficacy between robot-assisted and manual therapy are limited.
Purpose of Study
- To compare the clinical efficacy of robot-assisted therapy versus conventional manual therapy in early post-stroke lower limb rehabilitation.
- To assess patient comfort during both therapy modalities.
- To determine the feasibility and safety of integrating bedside rehabilitation robots into early stroke care.
Methods Used
- Randomized controlled trial with 40 inpatients with first-onset stroke and lower limb muscle strength ≤ grade 2.
- Patients randomly assigned to robot-assisted or conventional manual therapy groups.
- Two-stage intervention: passive training (weeks 1–2), followed by active/resistive training (weeks 3–4).
- Outcome measures: General Comfort Questionnaire (GCQ), Fugl-Meyer Assessment for lower extremities (FMA-LE), Modified Ashworth Scale (MAS), and Modified Barthel Index (MBI).
Main Results
- Robot-assisted therapy achieved similar early motor gains as manual therapy.
- Robot-assisted group reported significantly higher comfort scores after both intervention phases.
- Only the robot-assisted group showed a significant increase in comfort after the second phase.
- Robot-assisted group demonstrated greater improvements in lower limb motor recovery and functional independence (MBI) compared to the control group.
Conclusions
- Bedside rehabilitation robots are feasible and safe for early post-stroke care.
- Robot-assisted therapy enhances patient comfort and may improve functional outcomes beyond conventional manual therapy.
- Robotic interventions can address workload and consistency issues in traditional rehabilitation.
