StrokeNCT04625127
GaitBetter: Motor and Cognitive Training for Gait Rehabilitation and Falls Prevention in Stroke Survivors.
A study testing Treadmill gait training with GaitBetter in people with Stroke and Gait, Hemiplegic, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial summary
In this research study, the investigators aim to test the usability and efficacy of the GaitBetter system for gait rehabilitation after stroke. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Gait, Hemiplegic, Hemiplegia
- What is being tested?
- Treadmill gait training with GaitBetter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2021to Aug 2026
- Phase
- Interventional
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and females of age between 18 to 85 year of age
- History of one-sided ischemic or hemorrhagic stroke
- Chronic: more than 6 months post-stroke (Aim 1 and Aim 2)
- Subacute: within 8 weeks post-stroke (Aim 1 and Aim 3)
- Residual functional impairment of a lower extremity as a result of the stroke
- Ability to walk at least 15 meters with or without assistive devices (FIM walk subsection, levels 6 and 7)
- Ability to walk 3 consecutive minutes (5 minutes for Aim 2) on a treadmill at a speed equal to or greater than 0.22 m/s (0.8 km/h or 0.5 mph) with or without hand support.
- Medical clearance received from treating physician to participate in the gait training program proposed in the study
Who cannot join
- Severe aphasia limiting the ability to express needs or discomfort verbally or non-verbally
- Cognitive impairment limiting the ability to understand and follow instructions (as assessed by a score <23 on the Mini Mental State Examination)
- Previous diagnosis of neurological diseases other than stroke
- Recent history of lower extremity fractures (<12 months ago), unhealed wounds
- Current indication for isolation precautions (e.g. MRSA, VRE, C. difficile, and others)
- Severe visual impairments (as assessed by the NIH Stroke Scale Visual Field subscale. score >0)
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- Hemispatial neglect (as assessed by the Line Bisection Test)
- Subjects diagnosed with a medical condition that would interfere with their participation in regular sustained exercise (such as a severe pulmonary and/or cardiovascular condition)
- For Aim 2: currently participating in a gait training intervention (PT or research)
- Adults with impaired decision-making capacity
- Women who are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Hospital Boston
Boston, Massachusetts, 02129
About this study
In this research study, the investigators aim to test the usability and efficacy of the GaitBetter system for gait rehabilitation after stroke.
Read the detailed description
This study consists of 3 distinct aims:
In Aim 1, the investigators will evaluate clinical acceptance of the GaitBetter solution by subjects and therapists. To do so, the investigators will run a pilot study to gather feedback from stakeholders (not reported here).
In Aim 2, the investigators will evaluate the efficacy of using the GaitBetter solution to improve motor-cognitive function of chronic stroke survivors. To do so, the investigators will run a single-arm, non-randomized study to test the hypothesis that the GaitBetter training is effective in improving gait and cognition in individuals with chronic stroke.
In Aim 3, the investigators will explore the efficacy of using the GaitBetter solution for improving rehabilitation outcomes in sub-acute stroke survivors. To do so, the investigators will run a randomized, controlled study to evaluate the effects of using the GaitBetter system in patients with subacute stroke on recovery trajectory.
- Conditions
- Stroke, Gait, Hemiplegic, Hemiplegia
- Being tested
- Treadmill gait training with GaitBetter, Treadmill gait training with GaitBetter + Standard of care, Standard of care
- Keywords
- Stroke, Gait, Falls
- Medical subject headings
- Stroke, Gait Disorders, Neurologic, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill gait training with GaitBetterDevice
Participants will receive gait training with the GaitBetter solution for a total of 15 sessions (3 days a week for 5 weeks) each lasting approximately 45 minutes.
Treadmill gait training with GaitBetter + Standard of careOther
Participants will receive gait training with the GaitBetter solution for a total of 15 sessions (3 days a week for 5 weeks) each lasting approximately 45 minutes. In addition, the investigators will record the number and duration of therapy sessions followed by the participant during standard of care.
Standard of careOther
Participants will follow their standard of care. The investigators will record the number and duration of therapy sessions followed during standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Aim 2: Efficacy of the GaitBetter to improve motor-cognitive function of chronic stroke survivors | Experimental | The investigators propose a single-arm, non-randomized study to test the hypothesis that the GaitBetter training is effective in improving gait and cognition in individuals with chronic stroke. This design was chosen given the expected stability of functional recovery in this population. Receives: Device: Treadmill gait training with GaitBetter |
| Aim 3: Efficacy of the GaitBetter to improve rehabilitation outcomes in sub-acute stroke survivors | Experimental | The investigators propose a randomized, controlled study to evaluate the effects of using the GaitBetter system in patients with subacute stroke on recovery trajectory. Receives: Other: Treadmill gait training with GaitBetter + Standard of care; Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
10 meter walk test (in chronic stroke survivors, Aim 2)
Evaluation of gait speed of chronic stroke survivors, in meters per second
Measured: Change from baseline scores at post-intervention (after 5 weeks)
10 meter walk test (in subacute stroke survivors, Aim 3)
Evaluation of gait speed of subacute stroke survivors, in meters per second
Measured: Change from baseline scores at post-intervention (after 5 weeks)
Trail making test (in chronic stroke survivors, Aim 2)
Evaluation of cognition status, in chronic stroke survivors. The test record the time to accomplish the task (higher values indicate slower performance)
Measured: Change from baseline scores at post-intervention (after 5 weeks)
Trail making test (in subacute stroke survivors, Aim 3)
Evaluation of cognition status, in subacute stroke survivors. The test record the time to accomplish the task (higher values indicate slower performance)
Measured: Change from baseline scores at post-intervention (after 5 weeks)
Balance Evaluation Systems Test (mini-BESTest, in chronic stroke survivors, Aim 2)
Comprehensive evaluation of balance and falls risks in chronic stroke survivors. Score from 0 to 108. Higher scores are reflecting better balance
Measured: Change from baseline scores at post-intervention (after 5 weeks)
Aim 3: Balance Evaluation Systems Test (mini-BESTest, in subacute stroke survivors, Aim 3)
Comprehensive evaluation of balance and falls risks in subacute stroke survivors. Score from 0 to108. Higher scores are reflecting better balance
Measured: Change from baseline scores at post-intervention (after 5 weeks)
Secondary outcomes (10)
Step length (in chronic stroke survivors, Aim 2)
Evaluation of gait step length in chronic stroke survivors with an 3D motion capture system (in meters)
Measured: Change from baseline scores at post-intervention (after 5 weeks)
Step length (in subacute stroke survivors, Aim 3)
Evaluation of gait step length in subacute stroke survivors with an 3D motion capture system (in meters)
Measured: Change from baseline scores at post-intervention (after 5 weeks)
Step width (in chronic stroke survivors, Aim 2)
Evaluation of gait step width in chronic stroke survivors with an 3D motion capture system (in meters)
Measured: Change from baseline scores at post-intervention (after 5 weeks)
Step width (in subacute stroke survivors, Aim 3)
Evaluation of gait step width in subacute stroke survivors with an 3D motion capture system (in meters)
Measured: Change from baseline scores at post-intervention (after 5 weeks)
Step symmetry (in chronic stroke survivors, Aim 2)
Evaluation of gait step symmetry in chronic stroke survivors with an 3D motion capture system (ratio between paretic and non-paretic leg)
Measured: Change from baseline scores at post-intervention (after 5 weeks)
Step symmetry (in subacute stroke survivors, Aim 3)
Evaluation of gait step symmetry in subacute stroke survivors with an 3D motion capture system (ratio between paretic and non-paretic leg)
Measured: Change from baseline scores at post-intervention (after 5 weeks)
Stance time (in chronic stroke survivors, Aim 2)
Evaluation of gait stance time in chronic stroke survivors with an 3D motion capture system (in seconds)
Measured: Change from baseline scores at post-intervention (after 5 weeks)
Stance time (in subacute stroke survivors, Aim 3)
Evaluation of gait stance time in subacute stroke survivors with an 3D motion capture system (in seconds)
Measured: Change from baseline scores at post-intervention (after 5 weeks)
Swing time (in chronic stroke survivors, Aim 2)
Evaluation of gait swing time in chronic stroke survivors with an 3D motion capture system (in seconds)
Measured: Change from baseline scores at post-intervention (after 5 weeks)
Swing time (in subacute stroke survivors, Aim 3)
Evaluation of gait swing time in subacute stroke survivors with an 3D motion capture system (in seconds)
Measured: Change from baseline scores at post-intervention (after 5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start23 Jul 2021
- Primary completionAug 2026 (estimated)
- Study completionAug 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GoldenGait LTD
- Responsible party
- Principal investigator, Paolo Bonato, Spaulding Rehabilitation Hospital
- Investigators
- Paolo Bonato, PhD, Principal investigator, Harvard Medical School (HMS and HSDM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04625127
- Sponsor's protocol ID
- 2020P002544
- Status last verified
- Jul 2026
- First submitted
- 27 Oct 2020
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No