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NCT Number: NCT04625127

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

In this research study, the investigators aim to test the usability and efficacy of the GaitBetter system for gait rehabilitation after stroke.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Gait Disorders, Neurologic Gait, Hemiplegic Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spaulding Rehabilitation Hospital Boston

Boston, Massachusetts, 02129, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treadmill gait training with GaitBetter

Device

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 care

Other

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 care

Other

Participants will follow their standard of care. The investigators will record the number and duration of therapy sessions followed during standard of care.

Primary outcomes

  1. 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

  2. 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

  3. 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)

  4. 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)

  5. 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

  6. 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

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

Sponsors and collaborators

Lead sponsor

Spaulding Rehabilitation Hospital

Other

Collaborators

  • GoldenGait LTD

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Nov 12, 2020
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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