StrokeNCT05837975
Effect of the Exoskeleton for Assisting Ambulatory Activities in People With Subacute Stroke
A study testing FREE Walk Exoskeleton and Traditional Rehabilitation in people with Stroke and Exoskeleton, run by Taipei Hospital, Ministry of Health and Welfare at 1 site in Taiwan.
Trial summary
Background: Although rehabilitation activities, including physical therapy, are known to be beneficial for stroke patients, many patients still have poor walking function, especially after the acute phase of three months, where the recovery of lower limb walking ability through traditional rehabilitation therapy… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Exoskeleton
- What is being tested?
- FREE Walk Exoskeleton and Traditional Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Jul 2023to 15 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed with first-time stroke, with onset time within 1 month to 2 years from the time of recruitment, and all participants must sign an informed consent form.
- Patients must have independent walking ability, with or without cane.
- Lower limb muscle tone Modified Ashworth Scale <3.
- Able to perform a 25-meter walking test and a 10-step stair test without assistance from others.
- Cognitive function Mini-Mental State Examination > 23 points.
Who cannot join
- Combined with other central nervous system problems, such as brain tumors or spinal cord injuries.
- Clearly, lower limb joint diseases that cannot achieve complete hip, knee, and ankle joint activity are not excluded, but mild joint activity limitations caused by stroke are not excluded.
- Skin diseases that are not suitable for contact with exoskeleton devices.
- Unable to cooperate with the two-month research plan.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taipei Hospital, Ministry of Health and Welfare
New Taipei City, ROC, 24213
About this study
Official title: Effect of the Exoskeleton for Assisting Ambulatory Activities in People With Subacute Stroke : a Randomized, Cross-over Trial
Background: Although rehabilitation activities, including physical therapy, are known to be beneficial for stroke patients, many patients still have poor walking function, especially after the acute phase of three months, where the recovery of lower limb walking ability through traditional rehabilitation therapy gradually decreases, requiring alternative approaches. Exoskeleton robots appear to provide benefits for stroke patients by providing exercise guidance, thus improving their independent gait endurance and stair climbing ability. For stroke patients who cannot continue to improve through general rehabilitation and have ongoing mobility difficulties, exoskeletons may be a potential solution. However, previous literature on the use of exoskeletons to assist gait training has had mixed results, with one major reason being that the frequency of use is too low or the duration of use is too short, due to the high cost and inconvenience of travel to medical institutions. Therefore, it is necessary to find ways to enable patients to use them frequently and for a long period.
Method: investigators designed a non-blinded, randomized crossover trial to observe the potential benefits of using the device at home for one month. Patients were randomly divided into two groups, one receiving traditional rehabilitation first and the other using the exoskeleton first. There were four time points for testing: before, after the first stage of treatment, after the second stage of treatment, and one month after completing the second stage, to observe the sustained effects.
Read more
The testing involved executing a 6-minute walk test, timed up and go test, and a 10-step stair test (up and down) both with and without the device. An electronic software app was used to record daily usage time to determine the quantity and degree of home use.
Analysis: Repeated measures ANOVA models were used to analyze the effects and correlations of the experiment. The effects of the duration/frequency of use on dosage were also analyzed.
- Conditions
- Stroke, Exoskeleton
- Being tested
- FREE Walk Exoskeleton, Traditional Rehabilitation
- Keywords
- Subacute, Motor function, Robot, Walking assistance, Home mobility aid
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FREE Walk ExoskeletonDevice
Using a robotic exoskeleton to help with lower limb activities that are difficult due to neurological diseases. Used at home for individual patient training.
Traditional RehabilitationOther
Traditional rehabilitation refers to the use of conventional therapeutic methods.
| Study group | Role | What they receive |
|---|---|---|
| FREE Walk Exoskeleton vs Traditional Rehabilitation for Stroke Patients | Experimental | Participants in this arm will receive one month of traditional rehabilitation followed by one month of using the exoskeleton at home. Receives: Device: FREE Walk Exoskeleton; Other: Traditional Rehabilitation |
| Traditional Rehabilitation vs FREE Walk Exoskeleton for Stroke Patients | Experimental | Arm Description: Participants in this arm will receive one month of using the exoskeleton at home followed by one month of traditional rehabilitation. Receives: Device: FREE Walk Exoskeleton; Other: Traditional Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
final distance walked by the 6-minute walk test
Unit in meters, used to evaluate gait function and endurance. Participants walk along a 30-meter walkway, turning back within 6 minutes and recording the total distance covered at the end. Patients are allowed to rest during the test but not run. A higher score (walking distance) indicates better gait and endurance.This range overlaps with data reported in other populations.
Measured: before, after the first stage of treatment, after the second stage of treatment, and one month after completing the second stage, to observe the sustained effects.
Time difference of Timed up and go' test (TUG)
The TUG test (time measured in seconds) is a common clinical test for mobility function, using the 3-meter TUG test and following the procedure of Podsiadlo and Richardson's standards. The method involves asking the patient to sit on a straight-backed chair, then stand up, walk three meters forward at their usual pace, turn around, and return to sit on the chair. The total time is recorded with a stopwatch. The test is repeated five times. For this test, a lower score (time to complete) means better overall mobility.
Measured: before, after the first stage of treatment, after the second stage of treatment, and one month after completing the second stage, to observe the sustained effects.
Time difference of 10-step stair test
Timed Stair Test(TST) is a timed test measured in seconds, where the participant ascends and descends 10 steps of a staircase. The time taken to ascend(TSTup) and descend(TSTdn) is measured separately using a stopwatch. A lower score on this test indicates better stair climbing performance.
Measured: before, after the first stage of treatment, after the second stage of treatment, and one month after completing the second stage, to observe the sustained effects.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start5 Jul 2023
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Hospital, Ministry of Health and Welfare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837975
- Sponsor's protocol ID
- 202319
- Status last verified
- Nov 2024
- First submitted
- 20 Apr 2023
- Last updated
- 20 Nov 2024
- Results posted
- 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 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Exoskeleton for Assisting Ambulatory Activities in People With Subacute Stroke : a Randomized, Cross-over Trial
- ClinicalTrials.gov ID
- NCT05837975
- Acronym / sponsor ID
- 202319
- Conditions
- Stroke, Exoskeleton
- Keywords
- Subacute, Motor function, Robot, Walking assistance, Home mobility aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Taipei Hospital, Ministry of Health and WelfareUniversity, hospital or other
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 1 May 2023 (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.
Background: Although rehabilitation activities, including physical therapy, are known to be beneficial for stroke patients, many patients still have poor walking function, especially after the acute phase of three months, where the recovery of lower limb walking ability through traditional rehabilitation therapy gradually decreases, requiring alternative approaches. Exoskeleton robots appear to provide benefits for stroke patients by providing exercise guidance, thus improving their independent gait endurance and stair climbing ability. For stroke patients who cannot continue to improve through general rehabilitation and have ongoing mobility difficulties, exoskeletons may be a potential solution. However, previous literature on the use of exoskeletons to assist gait training has had mixed results, with one major reason being that the frequency of use is too low or the duration of use is too short, due to the high cost and inconvenience of travel to medical institutions. Therefore, it is necessary to find ways to enable patients to use them frequently and for a long period.
Method: investigators designed a non-blinded, randomized crossover trial to observe the potential benefits of using the device at home for one month. Patients were randomly divided into two groups, one receiving traditional rehabilitation first and the other using the exoskeleton first. There were four time points for testing: before, after the first stage of treatment, after the second stage of treatment, and one month after completing the second stage, to observe the sustained effects.
The testing involved executing a 6-minute walk test, timed up and go test, and a 10-step stair test (up and down) both with and without the device. An electronic software app was used to record daily usage time to determine the quantity and degree of home use.
Analysis: Repeated measures ANOVA models were used to analyze the effects and correlations of the experiment. The effects of the duration/frequency of use on dosage were also analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FREE Walk Exoskeleton vs Traditional Rehabilitation for Stroke Patients | Experimental | Device: FREE Walk Exoskeleton, Other: Traditional RehabilitationParticipants in this arm will receive one month of traditional rehabilitation followed by one month of using the exoskeleton at home. |
| Traditional Rehabilitation vs FREE Walk Exoskeleton for Stroke Patients | Experimental | Device: FREE Walk Exoskeleton, Other: Traditional RehabilitationArm Description: Participants in this arm will receive one month of using the exoskeleton at home followed by one month of traditional rehabilitation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with first-time stroke, with onset time within 1 month to 2 years from the time of recruitment, and all participants must sign an informed consent form.
- Patients must have independent walking ability, with or without cane.
- Lower limb muscle tone Modified Ashworth Scale <3.
- Able to perform a 25-meter walking test and a 10-step stair test without assistance from others.
- Cognitive function Mini-Mental State Examination > 23 points.
Key exclusion criteria (4 listed)
- Combined with other central nervous system problems, such as brain tumors or spinal cord injuries.
- Clearly, lower limb joint diseases that cannot achieve complete hip, knee, and ankle joint activity are not excluded, but mild joint activity limitations caused by stroke are not excluded.
- Skin diseases that are not suitable for contact with exoskeleton devices.
- Unable to cooperate with the two-month research plan.
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 |
|---|---|---|
| FREE Walk ExoskeletonUsing a robotic exoskeleton to help with lower limb activities that are difficult due to neurological diseases. Used at home for individual patient training. | Device | FREE Walk Exoskeleton vs Traditional Rehabilitation for Stroke Patients, Traditional Rehabilitation vs FREE Walk Exoskeleton for Stroke Patients |
| Traditional RehabilitationTraditional rehabilitation refers to the use of conventional therapeutic methods. | Other | FREE Walk Exoskeleton vs Traditional Rehabilitation for Stroke Patients, Traditional Rehabilitation vs FREE Walk Exoskeleton for Stroke Patients |
Primary outcome
final distance walked by the 6-minute walk test
Time frame: before, after the first stage of treatment, after the second stage of treatment, and one month after completing the second stage, to observe the sustained effects.
Unit in meters, used to evaluate gait function and endurance. Participants walk along a 30-meter walkway, turning back within 6 minutes and recording the total distance covered at the end. Patients are allowed to rest during the test but not run. A higher score (walking distance) indicates better gait and endurance.This range overlaps with data reported in other populations.
Time difference of Timed up and go' test (TUG)
Time frame: before, after the first stage of treatment, after the second stage of treatment, and one month after completing the second stage, to observe the sustained effects.
The TUG test (time measured in seconds) is a common clinical test for mobility function, using the 3-meter TUG test and following the procedure of Podsiadlo and Richardson's standards. The method involves asking the patient to sit on a straight-backed chair, then stand up, walk three meters forward at their usual pace, turn around, and return to sit on the chair. The total time is recorded with a stopwatch. The test is repeated five times. For this test, a lower score (time to complete) means better overall mobility.
Time difference of 10-step stair test
Time frame: before, after the first stage of treatment, after the second stage of treatment, and one month after completing the second stage, to observe the sustained effects.
Timed Stair Test(TST) is a timed test measured in seconds, where the participant ascends and descends 10 steps of a staircase. The time taken to ascend(TSTup) and descend(TSTdn) is measured separately using a stopwatch. A lower score on this test indicates better stair climbing performance.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: No
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FREE Walk Exoskeleton and Traditional Rehabilitation in people with Stroke and Exoskeleton, run by Taipei Hospital, Ministry of Health and Welfare 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 4 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: finished, as of the sponsor's last update on 20 Nov 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
final distance walked by the 6-minute walk test (time frame: before, after the first stage of treatment, after the second stage of treatment, and one month after completing the second stage, to observe the sustained effects.). The study lists 3 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 20 Nov 2024.