GaitBetter: Motor and Cognitive Training for Gait Rehabilitation and Falls Prevention in Stroke Survivors.

March 29, 2026 updated by: Paolo Bonato, Spaulding Rehabilitation Hospital
In this research study, the investigators aim to test the usability and efficacy of the GaitBetter system for gait rehabilitation after stroke.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02129
        • Spaulding Rehabilitation Hospital Boston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Aim 2: Efficacy of the GaitBetter to improve motor-cognitive function of chronic stroke survivors
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.
Device: Treadmill gait training with GaitBetter
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.
Experimental: Aim 3: Efficacy of the GaitBetter to improve rehabilitation outcomes in sub-acute stroke survivors
The investigators propose a randomized, controlled study to evaluate the effects of using the GaitBetter system in patients with subacute stroke on recovery trajectory.
Other: Treadmill gait training with GaitBetter + Standard of care
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.
Other: Standard of care
Participants will follow their standard of care. The investigators will record the number and duration of therapy sessions followed during standard of care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
10 meter walk test (in chronic stroke survivors, Aim 2)
Time Frame: Change from baseline scores at post-intervention (after 5 weeks)
Evaluation of gait speed of chronic stroke survivors, in meters per second
Change from baseline scores at post-intervention (after 5 weeks)
10 meter walk test (in subacute stroke survivors, Aim 3)
Time Frame: Change from baseline scores at post-intervention (after 5 weeks)
Evaluation of gait speed of subacute stroke survivors, in meters per second
Change from baseline scores at post-intervention (after 5 weeks)
Trail making test (in chronic stroke survivors, Aim 2)
Time Frame: Change from baseline scores at post-intervention (after 5 weeks)
Evaluation of cognition status, in chronic stroke survivors. The test record the time to accomplish the task (higher values indicate slower performance)
Change from baseline scores at post-intervention (after 5 weeks)
Trail making test (in subacute stroke survivors, Aim 3)
Time Frame: Change from baseline scores at post-intervention (after 5 weeks)
Evaluation of cognition status, in subacute stroke survivors. The test record the time to accomplish the task (higher values indicate slower performance)
Change from baseline scores at post-intervention (after 5 weeks)
Balance Evaluation Systems Test (mini-BESTest, in chronic stroke survivors, Aim 2)
Time Frame: Change from baseline scores at post-intervention (after 5 weeks)
Comprehensive evaluation of balance and falls risks in chronic stroke survivors. Score from 0 to 108. Higher scores are reflecting better balance
Change from baseline scores at post-intervention (after 5 weeks)
Aim 3: Balance Evaluation Systems Test (mini-BESTest, in subacute stroke survivors, Aim 3)
Time Frame: Change from baseline scores at post-intervention (after 5 weeks)
Comprehensive evaluation of balance and falls risks in subacute stroke survivors. Score from 0 to108. Higher scores are reflecting better balance
Change from baseline scores at post-intervention (after 5 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Step length (in chronic stroke survivors, Aim 2)
Time Frame: Change from baseline scores at post-intervention (after 5 weeks)
Evaluation of gait step length in chronic stroke survivors with an 3D motion capture system (in meters)
Change from baseline scores at post-intervention (after 5 weeks)
Step length (in subacute stroke survivors, Aim 3)
Time Frame: Change from baseline scores at post-intervention (after 5 weeks)
Evaluation of gait step length in subacute stroke survivors with an 3D motion capture system (in meters)
Change from baseline scores at post-intervention (after 5 weeks)
Step width (in chronic stroke survivors, Aim 2)
Time Frame: Change from baseline scores at post-intervention (after 5 weeks)
Evaluation of gait step width in chronic stroke survivors with an 3D motion capture system (in meters)
Change from baseline scores at post-intervention (after 5 weeks)
Step width (in subacute stroke survivors, Aim 3)
Time Frame: Change from baseline scores at post-intervention (after 5 weeks)
Evaluation of gait step width in subacute stroke survivors with an 3D motion capture system (in meters)
Change from baseline scores at post-intervention (after 5 weeks)
Step symmetry (in chronic stroke survivors, Aim 2)
Time Frame: Change from baseline scores at post-intervention (after 5 weeks)
Evaluation of gait step symmetry in chronic stroke survivors with an 3D motion capture system (ratio between paretic and non-paretic leg)
Change from baseline scores at post-intervention (after 5 weeks)
Step symmetry (in subacute stroke survivors, Aim 3)
Time Frame: Change from baseline scores at post-intervention (after 5 weeks)
Evaluation of gait step symmetry in subacute stroke survivors with an 3D motion capture system (ratio between paretic and non-paretic leg)
Change from baseline scores at post-intervention (after 5 weeks)
Stance time (in chronic stroke survivors, Aim 2)
Time Frame: Change from baseline scores at post-intervention (after 5 weeks)
Evaluation of gait stance time in chronic stroke survivors with an 3D motion capture system (in seconds)
Change from baseline scores at post-intervention (after 5 weeks)
Stance time (in subacute stroke survivors, Aim 3)
Time Frame: Change from baseline scores at post-intervention (after 5 weeks)
Evaluation of gait stance time in subacute stroke survivors with an 3D motion capture system (in seconds)
Change from baseline scores at post-intervention (after 5 weeks)
Swing time (in chronic stroke survivors, Aim 2)
Time Frame: Change from baseline scores at post-intervention (after 5 weeks)
Evaluation of gait swing time in chronic stroke survivors with an 3D motion capture system (in seconds)
Change from baseline scores at post-intervention (after 5 weeks)
Swing time (in subacute stroke survivors, Aim 3)
Time Frame: Change from baseline scores at post-intervention (after 5 weeks)
Evaluation of gait swing time in subacute stroke survivors with an 3D motion capture system (in seconds)
Change from baseline scores at post-intervention (after 5 weeks)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Montreal Cognitive Assessment (MoCA) (in chronic stroke survivors, Aim 2)
Time Frame: Change from baseline scores at post-intervention (after 5 weeks)
Measure of the cognitive status in chronic stroke survivors
Change from baseline scores at post-intervention (after 5 weeks)
Montreal Cognitive Assessment (MoCA) (in subacute stroke survivors, Aim 3)
Time Frame: Change from baseline scores at post-intervention (after 5 weeks)
Measure of the cognitive status in subacute stroke survivors
Change from baseline scores at post-intervention (after 5 weeks)
Symbol-Digit Modalities Test (SDMT) (in subacute stroke survivors, Aim 2)
Time Frame: Change from baseline scores at post-intervention (after 5 weeks)
Measure of the cognitive status in chronic stroke survivors
Change from baseline scores at post-intervention (after 5 weeks)
Symbol-Digit Modalities Test (SDMT) (in subacute stroke survivors, Aim 3)
Time Frame: Change from baseline scores at post-intervention (after 5 weeks)
Measure of the cognitive status in subacute stroke survivors
Change from baseline scores at post-intervention (after 5 weeks)
Hopkins Verbal Learning Test (Revised) (in chronic stroke survivors, Aim 2)
Time Frame: Change from baseline scores at post-intervention (after 5 weeks)
Measure of the cognitive status in chronic stroke survivors
Change from baseline scores at post-intervention (after 5 weeks)
Hopkins Verbal Learning Test (Revised) (in subacute stroke survivors, Aim 3)
Time Frame: Change from baseline scores at post-intervention (after 5 weeks)
Measure of the cognitive status in subacute stroke survivors
Change from baseline scores at post-intervention (after 5 weeks)
2-minutes walk test (2mwt) (in chronic stroke survivors, Aim 2)
Time Frame: Change from baseline scores at post-intervention (after 5 weeks)
Measure of the gait endurance in chronic stroke survivors
Change from baseline scores at post-intervention (after 5 weeks)
2-minutes walk test (2mwt) (in subacute stroke survivors, Aim 3)
Time Frame: Change from baseline scores at post-intervention (after 5 weeks)
Measure of the gait endurance in subacute stroke survivors
Change from baseline scores at post-intervention (after 5 weeks)
Functional Gait Assessment (FGA) (in chronic stroke survivors, Aim 2)
Time Frame: Change from baseline scores at post-intervention (after 5 weeks)
Measure of the gait mobility, balance and falls risks in chronic stroke survivors
Change from baseline scores at post-intervention (after 5 weeks)
Functional Gait Assessment (FGA) (in subacute stroke survivors, Aim 3)
Time Frame: Change from baseline scores at post-intervention (after 5 weeks)
Measure of the gait mobility, balance and falls risks in subacute stroke survivors
Change from baseline scores at post-intervention (after 5 weeks)
12-Item Short Form Health Survey (SF-12) (in chronic stroke survivors, Aim 2)
Time Frame: Change from baseline scores at post-intervention (after 5 weeks)
Self-reported measure of quality of life
Change from baseline scores at post-intervention (after 5 weeks)
12-Item Short Form Health Survey (SF-12) (in subacute stroke survivors, Aim 3)
Time Frame: Change from baseline scores at post-intervention (after 5 weeks)
Self-reported measure of quality of life
Change from baseline scores at post-intervention (after 5 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Spaulding Rehabilitation Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GoldenGait LTD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Paolo Bonato, PhD, Harvard Medical School (HMS and HSDM)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 23, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020P002544

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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