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

NCT04625127 | Active Not Recruiting FDA Device

• 1 other identifier: 2020P002544
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke; Gait, Hemiplegic; Hemiplegia

Keywords

Stroke; Gait; Falls

Outcome Measures

Primary Outcomes (6)

• 10 meter walk test (in chronic stroke survivors, Aim 2)

  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)

  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)

  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)

  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)

  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)

  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 Outcomes (10)

• Step length (in chronic stroke survivors, Aim 2)

  Change from baseline scores at post-intervention (after 5 weeks)

• Step length (in subacute stroke survivors, Aim 3)

  Change from baseline scores at post-intervention (after 5 weeks)

• Step width (in chronic stroke survivors, Aim 2)

  Change from baseline scores at post-intervention (after 5 weeks)

• Step width (in subacute stroke survivors, Aim 3)

  Change from baseline scores at post-intervention (after 5 weeks)

• Step symmetry (in chronic stroke survivors, Aim 2)

  Change from baseline scores at post-intervention (after 5 weeks)

Other Outcomes (12)

• Montreal Cognitive Assessment (MoCA) (in chronic stroke survivors, Aim 2)

  Change from baseline scores at post-intervention (after 5 weeks)

• Montreal Cognitive Assessment (MoCA) (in subacute stroke survivors, Aim 3)

  Change from baseline scores at post-intervention (after 5 weeks)

• Symbol-Digit Modalities Test (SDMT) (in subacute stroke survivors, Aim 2)

  Change from baseline scores at post-intervention (after 5 weeks)

Study Arms (2)

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.

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.

Other: Treadmill gait training with GaitBetter + Standard of care; Other: Standard of care

Interventions

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.

Aim 2: Efficacy of the GaitBetter to improve motor-cognitive function of chronic stroke survivors

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.

Aim 3: Efficacy of the GaitBetter to improve rehabilitation outcomes in sub-acute stroke survivors

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.

Aim 3: Efficacy of the GaitBetter to improve rehabilitation outcomes in sub-acute stroke survivors

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead
• GoldenGait LTD: collaborator

Study Sites (1)

Spaulding Rehabilitation Hospital Boston

Boston, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Stroke; Gait Disorders, Neurologic; Hemiplegia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paralysis

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Paolo Bonato, PhD

  Harvard Medical School (HMS and HSDM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Director of the Motion Analysis Laboratory

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 12, 2020
• Study Start: July 23, 2021
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)