StrokeNCT04251091
Ankle Exosuit Training in the Clinic to Community Community
A study testing Treadmill walking and Overground Walking in people with Stroke, run by Arun Jayaraman, PT, PhD at 1 site in United States.
Trial summary
This study focuses on investigating exosuit technology by evaluating its ability to provide a gait-restorative effect delivered in both clinic and community settings. The exosuit provides dynamic dorsiflexion and plantarflexion assist during walking. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Treadmill walking and Overground Walking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2020to 31 Dec 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 80 years old
- Stroke event occurred at least 6 months ago
- Observable gait deficits
- Able to walk without the support of another person for at least 2 minutes (with or without an assistive device or orthotic support)
- Passive ankle dorsiflexion range of motion to neutral with the knee extended (i.e., able to achieve an angle of 90 degrees between the shank and the foot)
- Resting heart rate between 40 - 100 bpm, inclusive
- Resting blood pressure between 90/60 and 170/90 mmHg, inclusive
- Medical clearance by a physician
Who cannot join
- Score of >1 on question 1b and >0 on question 1c on the NIH Stroke Scale
- Inability to communicate with investigators
- Neglect or hemianopia
- Unexplained dizziness in the last 6 months
- Pressure ulcers or skin wounds located at human-device interface sites
- History of significant Peripheral Artery Disease (PAD)
Show all 10Show fewer
- Unresolved Deep Vein Thrombosis (DVT)
- Uncontrolled or untreated hypertension
- Significant paretic ankle contractures (plantarflexion > 5°)
- Psychiatric or cognitive impairments that may interfere with proper operation of the device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ankle Exosuit Training in the Clinic to Community
This study focuses on investigating exosuit technology by evaluating its ability to provide a gait-restorative effect delivered in both clinic and community settings. The exosuit provides dynamic dorsiflexion and plantarflexion assist during walking. We will determine the effect of training parameters of intensity, repetition, and gait quality which are all key parameters associated with experience-dependent neuroplasticity. The other objective is to determine the effect of this intervention on community walking activity, walking speed, walking distance, and locomotor mechanics and energetics.
- Conditions
- Stroke
- Being tested
- Treadmill walking, Overground Walking
- Keywords
- exoskeleton, ambulation, robotics, Stroke, walking
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill walkingOther
Up to 5 bouts of 6 minutes walking on the treadmill with rest breaks allowed between sets
Overground WalkingOther
Up to 5 bouts of 6 minutes walking overground with rest breaks allowed between sets
| Study group | Role | What they receive |
|---|---|---|
| ReWalk Soft Exosuit | Experimental | During this study, we will explore which timing: early timing (10-20%), mid timing (50%) and late timing (90%) may be optimal for an individual and then carry out an 18 session training protocol. Receives: Other: Treadmill walking; Other: Overground Walking |
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
This test will examine the patient's gait speed. Patients will be directed to walk at their preferred and maximum but safe speed. Patients will be positioned 1 meter before the start line and instructed to walk the entire distance and past the end line approximately 1 meter. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundredth of a second (ex: 2.15 sec).
Measured: Baseline Day 1-3, Midpoint at week 6, Post-intervention at week 12
Secondary outcomes (2)
Change in 6 Minute Walk Test in distance from baseline
The 6 Minute Walk Test (6MWT) measures the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assistive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The test will be used to determine participant's gait efficiency at baseline and at study completion. The walk test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patient is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded.
Measured: Baseline Day 1-3, Midpoint at week 6, Post-intervention at week 12
Functional Gait Assessment (FGA)
The Functional Gait Assessment is a 10 item test used to assess postural stability during walking tasks. It has a maximum score of 30 with each item being scored 0-3. It may be performed with or without an assistive device; however, individuals lose a point on all items requiring a device.
Measured: Baseline Day 1-3, Midpoint at week 6, Post-intervention at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start10 Jan 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- Previous work has demonstrated that the tuning of the exosuit technology is important for each patient post stroke to be able to maximally utilize the technology. These modulations include when the plantarflexion force is delivered, and how to deliver the assistance within a training session however it is still unclear how to implement this into a training protocol. During a part of this study, we will explore which timing: early timing (10-20%), mid timing (50%) and late timing (90%) may be optimal for an individual and then carry out a training protocol
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arun Jayaraman, PT, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Education
- Responsible party
- Sponsor-investigator, Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab
- Investigators
- Arun Jayaraman, PT, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251091
- Sponsor's protocol ID
- STU00209869
- Status last verified
- Mar 2025
- First submitted
- 29 Jan 2020
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shin SY, Hohl K, Giffhorn M, Awad LN, Walsh CJ, Jayaraman A. Soft robotic exosuit augmented high intensity gait training on stroke survivors: a pilot study. J Neuroeng Rehabil. 2022 Jun 3;19(1):51. doi: 10.1186/s12984-022-01034-2.
PubMed 35655180
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ankle Exosuit Training in the Clinic to Community
- ClinicalTrials.gov ID
- NCT04251091
- Acronym / sponsor ID
- STU00209869
- Conditions
- Stroke
- Keywords
- exoskeleton, ambulation, robotics, Stroke, walking
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Arun Jayaraman, PT, PhDUniversity, hospital or other
- Collaborators
- U.S. Department of Education
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 31 Jan 2020 (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.
This study focuses on investigating exosuit technology by evaluating its ability to provide a gait-restorative effect delivered in both clinic and community settings. The exosuit provides dynamic dorsiflexion and plantarflexion assist during walking. We will determine the effect of training parameters of intensity, repetition, and gait quality which are all key parameters associated with experience-dependent neuroplasticity. The other objective is to determine the effect of this intervention on community walking activity, walking speed, walking distance, and locomotor mechanics and energetics.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Previous work has demonstrated that the tuning of the exosuit technology is important for each patient post stroke to be able to maximally utilize the technology. These modulations include when the plantarflexion force is delivered, and how to deliver the assistance within a training session however it is still unclear how to implement this into a training protocol. During a part of this study, we will explore which timing: early timing (10-20%), mid timing (50%) and late timing (90%) may be optimal for an individual and then carry out a training protocol
| Arm | Type | Receives |
|---|---|---|
| ReWalk Soft Exosuit | Experimental | Other: Treadmill walking, Other: Overground WalkingDuring this study, we will explore which timing: early timing (10-20%), mid timing (50%) and late timing (90%) may be optimal for an individual and then carry out an 18 session training protocol. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 - 80 years old
- Stroke event occurred at least 6 months ago
- Observable gait deficits
- Able to walk without the support of another person for at least 2 minutes (with or without an assistive device or orthotic support)
- Passive ankle dorsiflexion range of motion to neutral with the knee extended (i.e., able to achieve an angle of 90 degrees between the shank and the foot)
Key exclusion criteria (10 listed)
- Score of >1 on question 1b and >0 on question 1c on the NIH Stroke Scale
- Inability to communicate with investigators
- Neglect or hemianopia
- Unexplained dizziness in the last 6 months
- Pressure ulcers or skin wounds located at human-device interface sites
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 |
|---|---|---|
| Treadmill walkingUp to 5 bouts of 6 minutes walking on the treadmill with rest breaks allowed between sets | Other | ReWalk Soft Exosuit |
| Overground WalkingUp to 5 bouts of 6 minutes walking overground with rest breaks allowed between sets | Other | ReWalk Soft Exosuit |
Primary outcome
Change in 10 Meter Walk Test from baseline gait speed
Time frame: Baseline Day 1-3, Midpoint at week 6, Post-intervention at week 12
This test will examine the patient's gait speed. Patients will be directed to walk at their preferred and maximum but safe speed. Patients will be positioned 1 meter before the start line and instructed to walk the entire distance and past the end line approximately 1 meter. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundredth of a second (ex: 2.15 sec).
2 secondary outcomes
Change in 6 Minute Walk Test in distance from baseline
Time frame: Baseline Day 1-3, Midpoint at week 6, Post-intervention at week 12
Functional Gait Assessment (FGA)
Time frame: Baseline Day 1-3, Midpoint at week 6, Post-intervention at week 12
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 1 Apr 2025.
- Derived from this study: PubMed 35655180Shin SY, Hohl K, Giffhorn M, Awad LN, Walsh CJ, Jayaraman A. Soft robotic exosuit augmented high intensity gait training on stroke survivors: a pilot study. J Neuroeng Rehabil. 2022 Jun 3;19(1):51. doi: 10.1186/s12984-022-01034-2.
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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.
Arun Jayaraman, PT, PhD principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill walking and Overground Walking in people with Stroke, run by Arun Jayaraman, PT, PhD at 1 site in United States.
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 8 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 1 Apr 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 United States. 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?
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?
Change in 10 Meter Walk Test from baseline gait speed (time frame: Baseline Day 1-3, Midpoint at week 6, Post-intervention at week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04251091, which also lists 1 linked publication.
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 1 Apr 2025.