StrokeNCT07040215
Effects on Subacute Stroke With Robotic Assistive Gait Training
A study testing Freewalk lower limb Robotic Assistive Gait Training and Physiotherapy in people with Stroke and Stroke Gait Rehabilitation, run by Changhua Christian Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Stroke, Stroke Gait Rehabilitation
- What is being tested?
- Freewalk lower limb Robotic Assistive Gait Training and Physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Able to participate in rehabilitation training during the study period.
Who cannot join
- 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.
- Diagnosed with cardiopulmonary disease that contraindicates exercise training.
- Cognitive impairment that prevents understanding of training instructions or completion of questionnaires.
- Inability to complete the rehabilitation training protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Office of Human Subject Protection Changhua Christian Hospital contact
Taiwan1 site, 1 recruiting
- Recruiting
Changhua Christian Hospital
Changhua, Taiwan, 500
Chen-Jou Wu, 886-4-7238595 ext. 8377, d9010@cch.org.tw
Su-Fen Liao
About this study
Official title: The Effectiveness of Subacute Stroke Patients Receiving Robotic Assisted Gait Training
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.
Read the detailed description
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.
- Conditions
- Stroke, Stroke Gait Rehabilitation
- Being tested
- Freewalk lower limb Robotic Assistive Gait Training, Physiotherapy
- Keywords
- physiotherapy, Robotic Assistive Gait Training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freewalk lower limb Robotic Assistive Gait TrainingDevice
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.
PhysiotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional PT | Active comparator | Conventional Physiotherapy Receives: Other: Physiotherapy |
| Robotic Gait Training | Experimental | Conventional Physiotherapy combined with Robotic Assistive Gait Training Receives: Device: Freewalk lower limb Robotic Assistive Gait Training; Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline and after 4 weeks of intervention
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline and after 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Su-Fen Liao, Principal investigator, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040215
- Sponsor's protocol ID
- 250321
- Status last verified
- Jun 2025
- First submitted
- 15 May 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Subacute Stroke Patients Receiving Robotic Assisted Gait Training
- ClinicalTrials.gov ID
- NCT07040215
- Acronym / sponsor ID
- 250321
- Conditions
- Stroke, Stroke Gait Rehabilitation
- Keywords
- physiotherapy, Robotic Assistive Gait Training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional PT | Active comparator | Other: PhysiotherapyConventional Physiotherapy |
| Robotic Gait Training | Experimental | Device: Freewalk lower limb Robotic Assistive Gait Training, Other: PhysiotherapyConventional Physiotherapy combined with Robotic Assistive Gait Training |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Able to participate in rehabilitation training during the study period.
Key exclusion criteria (7 listed)
- 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.
- Diagnosed with cardiopulmonary disease that contraindicates exercise training.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Freewalk lower limb Robotic Assistive Gait TrainingParticipants 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. | Device | Robotic Gait Training |
| PhysiotherapyParticipants 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. | Other | Conventional PT, Robotic Gait Training |
Primary outcome
Gait Speed
Time frame: Baseline and after 4 weeks of intervention
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.
Step Length
Time frame: Baseline and after 4 weeks of intervention
Objective assessment of gait performance using two inertial sensors attached to the shoes. Measures include step length (meters)
Toe Clearance
Time frame: Baseline and after 4 weeks of intervention
Objective assessment of gait performance using two inertial sensors attached to the shoes. Measures include toe clearance (meters).
Timed Up and Go Test (TUG)
Time frame: Baseline and after 4 weeks of intervention
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.
Functional Independence Measure (FIM)
Time frame: Baseline and after 4 weeks of intervention
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.
4 secondary outcomes
Berg Balance Scale (BBS)
Time frame: Baseline and after 4 weeks of intervention
30-Second Chair Stand Test (30-CST)
Time frame: Baseline and after 4 weeks of intervention
Surface Electromyography (sEMG)
Time frame: Baseline and after 4 weeks of intervention
Short Form-12 Health Survey (SF-12)
Time frame: Baseline and after 4 weeks of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Office of Human Subject Protection Changhua Christian Hospital contact
Su-Fen Liao principal investigator
Changhua Christian Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Freewalk lower limb Robotic Assistive Gait Training and Physiotherapy in people with Stroke and Stroke Gait Rehabilitation, run by Changhua Christian Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Office of Human Subject Protection Changhua Christian Hospital (886-4-7238595 ext. 8377, d9010@cch.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Speed (time frame: Baseline and after 4 weeks of intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.