Effects on Subacute Stroke With Robotic Assistive Gait Training
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-70
SponsorChanghua Christian Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with stroke (ischemic or hemorrhagic) confirmed by medical imaging.
Subacute phase of stroke (onset within 1 to 3 months).
Moderate to good standing balance ability.
Sufficient cognitive ability to understand the study and follow instructions.
Disqualifiers
Body weight over 90 kg.
Presence of other neurological disorders.
Severe cardiovascular disease or other health conditions affecting mobility.
Significant lower limb pain, joint contracture, or spasticity (Modified Ashworth Scale score > 3) that impairs walking.
Trial design
Design model
Parallel
Treatments tested in this trial
Freewalk lower limb Robotic Assistive Gait Training
DeviceParticipants 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.
Physiotherapy
Other interventionParticipants 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Conventional PTActive comparator 1 intervention
Group B: Robotic Gait TrainingExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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 intervention2
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 intervention3
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 intervention4
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 interventionSecondary outcomes
1
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 intervention2
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 intervention3
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 intervention4
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 interventionSponsors and contacts
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Source ClinicalTrials.gov