An interventional study of Freewalk lower limb Robotic Assistive Gait Training and Physiotherapy in Stroke and Stroke Gait Rehabilitation, sponsored by Changhua Christian Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 45 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-06-27.
Sponsored by Changhua Christian Hospital · Not applicable, Interventional, and Treatment
The goal of this randomized controlled trial is to learn about the effects of Robotic Assisted Gait Training (RAGT) combined with traditional physical therapy in subacute stroke patients. The main question it aims to answer is:
- Does RAGT combined with traditional physical therapy improve gait and functional performance in subacute stroke patients compared to traditional physical therapy alone? Participants who are subacute stroke patients will be randomly assigned to receive either both RAGT and traditional physical therapy or only traditional physical therapy. Their gait and functional performance will be assessed during the study period.
The sequelae of stroke have a significant impact on patients' physical functions and quality of life. Although traditional physical therapy can help some patients regain function, its effectiveness is often limited. Therefore, exploring new rehabilitation technologies has become one of the key tasks in the medical field. Robotic Assisted Gait Training (RAGT) is an emerging technology that provides high-intensity and repetitive gait training, making it particularly suitable for patients in the post-stroke rehabilitation phase. Recent studies have shown that RAGT can significantly improve gait abilities in stroke patients, including walking speed and functional performance. Therefore, this study will adopt a randomized controlled trial design, recruiting 20 subacute stroke patients who will be randomly assigned to either a group receiving both RAGT and traditional physical therapy or a group receiving only traditional physical therapy. The study will compare differences in gait and functional performance between the two groups during the rehabilitation process, aiming to provide a foundation for future personalized and precision treatment plans.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 40 is below the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Changhua Christian Hospital is the lead sponsor of 76 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Conventional Physiotherapy
Other: Physiotherapy
Conventional Physiotherapy combined with Robotic Assistive Gait Training
Device: Freewalk lower limb Robotic Assistive Gait Training · Other: Physiotherapy
Participants in this group will receive robotic-assisted gait training three times per week (every other day) for 30 minutes per session, using the FREE Walk exoskeleton device (FREE Bionics, Taiwan). The device assists with walking, standing, and sitting. A physical therapist will help the participant wear the exoskeleton and supervise the training, adjusting the level of robotic support and intensity based on the participant's ability. In addition to RAGT, participants will receive conventional stroke rehabilitation therapy (including sit to stand, balance and gait training) on the remaining weekdays (2 days/week), 30 minutes per session. Intervention Duration: 4 weeks.
Participants in this group will receive conventional stroke rehabilitation therapy (including sit to stand, balance and gait training) 5 days/week, 30 minutes per session. Intervention Duration: 4 weeks.
Gait Speed
Gait speed will be calculated as distance divided duration. A timer will collect the duration (seconds, s) while subjects walk 3 meters (m, distance). The gait speed showed as (m/s) directly.
Time frame: Baseline and after 4 weeks of intervention
Step Length
Objective assessment of gait performance using two inertial sensors attached to the shoes. Measures include step length (meters)
Time frame: Baseline and after 4 weeks of intervention
Toe Clearance
Objective assessment of gait performance using two inertial sensors attached to the shoes. Measures include toe clearance (meters).
Time frame: Baseline and after 4 weeks of intervention
Timed Up and Go Test (TUG)
Assesses functional mobility and fall risk. Participants stand up from a chair, walk 3 meters, turn around, return, and sit down. The time taken to complete the task is recorded.
Time frame: Baseline and after 4 weeks of intervention
Functional Independence Measure (FIM)
Evaluates the level of a participant's independence in daily activities. The FIM includes 18 items across motor and cognitive domains, each scored from 1 (total assistance) to 7 (complete independence), with a total score range of 18 to 126.
Time frame: Baseline and after 4 weeks of intervention
Berg Balance Scale (BBS)
Assesses participants' static and dynamic balance abilities using a 14-item scale. Each item is scored from 0 to 4, with a total score ranging from 0 to 56. Higher scores indicate better balance.
Time frame: Baseline and after 4 weeks of intervention
30-Second Chair Stand Test (30-CST)
Measures lower limb strength and endurance. Participants are asked to stand up and sit down from a standard chair as many times as possible within 30 seconds, with arms crossed over the chest.
Time frame: Baseline and after 4 weeks of intervention
Surface Electromyography (sEMG)
Non-invasive recording of muscle activity during walking using adhesive electrodes placed on major lower limb muscles (e.g., quadriceps, tibialis anterior, gastrocnemius).
Time frame: Baseline and after 4 weeks of intervention
Short Form-12 Health Survey (SF-12)
Self-reported measure of health-related quality of life. Includes 12 questions covering 8 domains such as physical functioning, role limitations, pain, general health, vitality, social functioning, emotional role, and mental health.
Time frame: Baseline and after 4 weeks of intervention
Plan to share: No
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Changhua Christian Hospital