StrokeNCT07037849
The Effects of the Control Strategies of Wearable Lower Limb Rehabilitation Robots
A study testing Robot-assisted overground gait training in people with Stroke and Gait Training, run by Eighth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
Post-stroke patients were required to complete a session of robot-assisted training, which involved nine repetitions of 5-meter overground walking (three trials for each of the three controllers) in a rectangular hospital corridor. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke, Gait Training, Gait Disorders
- What is being tested?
- Robot-assisted overground gait training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 23 Oct 2024to 22 Apr 2027
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke patients aged between 18 and 75 years. Patients who are medically stable and able to stand and walk independently for at least 10 meters during rehabilitation.
- Stroke event occurred at least 3 months ago Patients with impaired lower limb motor function but with some degree of muscle activity in the lower extremities.
- Patients without severe cognitive impairment and capable of understanding and following the treatment protocol.
- Patients without severe balance or coordination disorders, able to maintain balance and perform gait training with assistive devices.
- Patients without lower limb fractures or other serious skeletal issues affecting the lower limbs.
- Patients without severe cardiovascular or other serious illnesses and able to tolerate the intensity and duration of rehabilitation therapy.
- Patients willing to participate in the study and able to provide written informed consent.
Who cannot join
- Severe cognitive impairment that prevents the patient from understanding or complying with the treatment protocol.
- Severe balance or coordination disorders that prevent the patient from maintaining balance and participating in gait training, even with assistive devices.
- Other serious motor disorders, such as abnormal muscle tone or ataxia, which may interfere with the effectiveness of rehabilitation therapy.
- Active cardiovascular disease or other serious systemic illnesses that may affect the patient's safety or treatment outcomes.
- Lower limb fractures or other serious skeletal issues that may impact the suitability and safety of robot-assisted rehabilitation therapy.
- Patients currently receiving other rehabilitation or experimental treatments. Patients with skin ulcers, infections, or other severe skin conditions that may interfere with the use and application of robotic devices.
- Unexplained discomfort or pain symptoms that may limit the patient's ability to participate in rehabilitation therapy.
- Failure to meet other specific inclusion criteria outlined in the study protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Eight affiliated hospital, Sun Yat-Sen University
Shenzhen, Guangzhou, 518033
Shaofeng Zhao, 86 18898773680, zhaosf1@163.com
Chuyao Jian
About this study
Official title: Effects of Control Strategies in Wearable Lower Limb Rehabilitation Robots
Post-stroke patients were required to complete a session of robot-assisted training, which involved nine repetitions of 5-meter overground walking (three trials for each of the three controllers) in a rectangular hospital corridor.
- Conditions
- Stroke, Gait Training, Gait Disorders
- Being tested
- Robot-assisted overground gait training
- Keywords
- Robots, Assistive robots, Trajectory, Torque, Force, Robot kinematics, Knee, Limb, Muscles, Hip
- Medical subject headings
- Stroke, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted overground gait trainingDevice
Post-stroke patients were required to complete a session of robot-assisted training, which involved nine repetitions of 5-meter overground walking (three trials for each of the three controllers).
| Study group | Role | What they receive |
|---|---|---|
| Robot gait training group | Experimental | During this study, we will explore which control strategy: Aware Hip Knee Coupling Control (AHKC), Passive control (PC), or fixed compliance control (FCC) may be optimal for post-stroke subjects Receives: Device: Robot-assisted overground gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 10 Meter Walk Test from baseline gait speed
Gait speed will be assessed by instructing participants to walk at their maximum safe speed. Each participant will start 1 meter before the designated start line and continue walking until 1 meter past the finish line. The time taken to traverse the measured distance will be recorded using a stopwatch to the nearest one hundredth of a second.
Measured: Baseline, immediately after intervention
Secondary outcomes (1)
Change scores of Lower Extremity Fugl-Meyer Assessment (FMA-LE)
The Lower Extremity Fugl-Meyer Assessment (FMA-LE) is a validated, performance-based scale used to evaluate motor function, reflexes, coordination, and movement synergy of the lower limb in stroke patients. The FMA-LE consists of 17 items, each scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully), with a total possible score ranging from 0 to 34. Higher scores indicate better lower limb motor function. Assessments will be performed by trained evaluators according to standardized procedures.
Measured: Baseline, immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start23 Oct 2024
- Primary completion22 Oct 2026 (estimated)
- Study completion22 Apr 2027 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eighth Affiliated Hospital, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037849
- Sponsor's protocol ID
- 202421602
- Other IDs
- U21A20136
- Status last verified
- May 2025
- First submitted
- 5 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Control Strategies in Wearable Lower Limb Rehabilitation Robots
- ClinicalTrials.gov ID
- NCT07037849
- Acronym / sponsor ID
- 202421602
- Conditions
- Stroke, Gait Training, Gait Disorders
- Keywords
- Robots, Assistive robots, Trajectory, Torque, Force, Robot kinematics, Knee, Limb
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Eighth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 22 Oct 2026 (estimated)
- Study completion
- 22 Apr 2027 (estimated)
- First posted
- 26 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.
Post-stroke patients were required to complete a session of robot-assisted training, which involved nine repetitions of 5-meter overground walking (three trials for each of the three controllers) in a rectangular hospital corridor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robot gait training group | Experimental | Device: Robot-assisted overground gait trainingDuring this study, we will explore which control strategy: Aware Hip Knee Coupling Control (AHKC), Passive control (PC), or fixed compliance control (FCC) may be optimal for post-stroke subjects |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Stroke patients aged between 18 and 75 years. Patients who are medically stable and able to stand and walk independently for at least 10 meters during rehabilitation.
- Stroke event occurred at least 3 months ago Patients with impaired lower limb motor function but with some degree of muscle activity in the lower extremities.
- Patients without severe cognitive impairment and capable of understanding and following the treatment protocol.
- Patients without severe balance or coordination disorders, able to maintain balance and perform gait training with assistive devices.
- Patients without lower limb fractures or other serious skeletal issues affecting the lower limbs.
Key exclusion criteria (8 listed)
- Severe cognitive impairment that prevents the patient from understanding or complying with the treatment protocol.
- Severe balance or coordination disorders that prevent the patient from maintaining balance and participating in gait training, even with assistive devices.
- Other serious motor disorders, such as abnormal muscle tone or ataxia, which may interfere with the effectiveness of rehabilitation therapy.
- Active cardiovascular disease or other serious systemic illnesses that may affect the patient's safety or treatment outcomes.
- Lower limb fractures or other serious skeletal issues that may impact the suitability and safety of robot-assisted rehabilitation therapy.
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 |
|---|---|---|
| Robot-assisted overground gait trainingPost-stroke patients were required to complete a session of robot-assisted training, which involved nine repetitions of 5-meter overground walking (three trials for each of the three controllers). | Device | Robot gait training group |
Primary outcome
Change in 10 Meter Walk Test from baseline gait speed
Time frame: Baseline, immediately after intervention
Gait speed will be assessed by instructing participants to walk at their maximum safe speed. Each participant will start 1 meter before the designated start line and continue walking until 1 meter past the finish line. The time taken to traverse the measured distance will be recorded using a stopwatch to the nearest one hundredth of a second.
1 secondary outcome
Change scores of Lower Extremity Fugl-Meyer Assessment (FMA-LE)
Time frame: Baseline, immediately after 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 26 Jun 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-assisted overground gait training in people with Stroke and Gait Training, run by Eighth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
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 7 inclusion and 8 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 26 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 China. 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 Shaofeng Zhao (86 18898773680, zhaosf1@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 10 Meter Walk Test from baseline gait speed (time frame: Baseline, immediately after intervention). 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 26 Jun 2025.