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

Primary Purpose

Stroke, Gait, Hemiplegic, Hemiplegia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treadmill gait training with GaitBetter
Treadmill gait training with GaitBetter + Standard of care
Standard of care
Sponsored by
Spaulding Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Gait, Falls

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Spaulding Rehabilitation Hospital BostonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

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

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

Arm Description

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.

The investigators propose a randomized, controlled study to evaluate the effects of using the GaitBetter system in patients with subacute stroke on recovery trajectory.

Outcomes

Primary Outcome Measures

10 meter walk test (in chronic stroke survivors, Aim 2)
Evaluation of gait speed of chronic stroke survivors, in meters per second
10 meter walk test (in subacute stroke survivors, Aim 3)
Evaluation of gait speed of subacute stroke survivors, in meters per second
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)
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)
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
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

Secondary Outcome Measures

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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

Full Information

First Posted
October 27, 2020
Last Updated
August 4, 2022
Sponsor
Spaulding Rehabilitation Hospital
Collaborators
GoldenGait LTD
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1. Study Identification

Unique Protocol Identification Number
NCT04625127
Brief Title
GaitBetter: Motor and Cognitive Training for Gait Rehabilitation and Falls Prevention in Stroke Survivors.
Official Title
GaitBetter: Motor and Cognitive Training for Gait Rehabilitation and Falls Prevention in Stroke Survivors.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 23, 2021 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital
Collaborators
GoldenGait LTD

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Gait, Hemiplegic, Hemiplegia
Keywords
Stroke, Gait, Falls

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aim 2: Efficacy of the GaitBetter to improve motor-cognitive function of chronic stroke survivors
Arm Type
Experimental
Arm Description
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.
Arm Title
Aim 3: Efficacy of the GaitBetter to improve rehabilitation outcomes in sub-acute stroke survivors
Arm Type
Experimental
Arm Description
The investigators propose a randomized, controlled study to evaluate the effects of using the GaitBetter system in patients with subacute stroke on recovery trajectory.
Intervention Type
Device
Intervention Name(s)
Treadmill gait training with GaitBetter
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treadmill gait training with GaitBetter + Standard of care
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
Participants will follow their standard of care. The investigators will record the number and duration of therapy sessions followed during standard of care.
Primary Outcome Measure Information:
Title
10 meter walk test (in chronic stroke survivors, Aim 2)
Description
Evaluation of gait speed of chronic stroke survivors, in meters per second
Time Frame
Change from baseline scores at post-intervention (after 5 weeks)
Title
10 meter walk test (in subacute stroke survivors, Aim 3)
Description
Evaluation of gait speed of subacute stroke survivors, in meters per second
Time Frame
Change from baseline scores at post-intervention (after 5 weeks)
Title
Trail making test (in chronic stroke survivors, Aim 2)
Description
Evaluation of cognition status, in chronic stroke survivors. The test record the time to accomplish the task (higher values indicate slower performance)
Time Frame
Change from baseline scores at post-intervention (after 5 weeks)
Title
Trail making test (in subacute stroke survivors, Aim 3)
Description
Evaluation of cognition status, in subacute stroke survivors. The test record the time to accomplish the task (higher values indicate slower performance)
Time Frame
Change from baseline scores at post-intervention (after 5 weeks)
Title
Balance Evaluation Systems Test (mini-BESTest, in chronic stroke survivors, Aim 2)
Description
Comprehensive evaluation of balance and falls risks in chronic stroke survivors. Score from 0 to 108. Higher scores are reflecting better balance
Time Frame
Change from baseline scores at post-intervention (after 5 weeks)
Title
Aim 3: Balance Evaluation Systems Test (mini-BESTest, in subacute stroke survivors, Aim 3)
Description
Comprehensive evaluation of balance and falls risks in subacute stroke survivors. Score from 0 to108. Higher scores are reflecting better balance
Time Frame
Change from baseline scores at post-intervention (after 5 weeks)
Secondary Outcome Measure Information:
Title
Step length (in chronic stroke survivors, Aim 2)
Description
Evaluation of gait step length in chronic stroke survivors with an 3D motion capture system (in meters)
Time Frame
Change from baseline scores at post-intervention (after 5 weeks)
Title
Step length (in subacute stroke survivors, Aim 3)
Description
Evaluation of gait step length in subacute stroke survivors with an 3D motion capture system (in meters)
Time Frame
Change from baseline scores at post-intervention (after 5 weeks)
Title
Step width (in chronic stroke survivors, Aim 2)
Description
Evaluation of gait step width in chronic stroke survivors with an 3D motion capture system (in meters)
Time Frame
Change from baseline scores at post-intervention (after 5 weeks)
Title
Step width (in subacute stroke survivors, Aim 3)
Description
Evaluation of gait step width in subacute stroke survivors with an 3D motion capture system (in meters)
Time Frame
Change from baseline scores at post-intervention (after 5 weeks)
Title
Step symmetry (in chronic stroke survivors, Aim 2)
Description
Evaluation of gait step symmetry in chronic stroke survivors with an 3D motion capture system (ratio between paretic and non-paretic leg)
Time Frame
Change from baseline scores at post-intervention (after 5 weeks)
Title
Step symmetry (in subacute stroke survivors, Aim 3)
Description
Evaluation of gait step symmetry in subacute stroke survivors with an 3D motion capture system (ratio between paretic and non-paretic leg)
Time Frame
Change from baseline scores at post-intervention (after 5 weeks)
Title
Stance time (in chronic stroke survivors, Aim 2)
Description
Evaluation of gait stance time in chronic stroke survivors with an 3D motion capture system (in seconds)
Time Frame
Change from baseline scores at post-intervention (after 5 weeks)
Title
Stance time (in subacute stroke survivors, Aim 3)
Description
Evaluation of gait stance time in subacute stroke survivors with an 3D motion capture system (in seconds)
Time Frame
Change from baseline scores at post-intervention (after 5 weeks)
Title
Swing time (in chronic stroke survivors, Aim 2)
Description
Evaluation of gait swing time in chronic stroke survivors with an 3D motion capture system (in seconds)
Time Frame
Change from baseline scores at post-intervention (after 5 weeks)
Title
Swing time (in subacute stroke survivors, Aim 3)
Description
Evaluation of gait swing time in subacute stroke survivors with an 3D motion capture system (in seconds)
Time Frame
Change from baseline scores at post-intervention (after 5 weeks)
Other Pre-specified Outcome Measures:
Title
Montreal Cognitive Assessment (MoCA) (in chronic stroke survivors, Aim 2)
Description
Measure of the cognitive status in chronic stroke survivors
Time Frame
Change from baseline scores at post-intervention (after 5 weeks)
Title
Montreal Cognitive Assessment (MoCA) (in subacute stroke survivors, Aim 3)
Description
Measure of the cognitive status in subacute stroke survivors
Time Frame
Change from baseline scores at post-intervention (after 5 weeks)
Title
Symbol-Digit Modalities Test (SDMT) (in subacute stroke survivors, Aim 2)
Description
Measure of the cognitive status in chronic stroke survivors
Time Frame
Change from baseline scores at post-intervention (after 5 weeks)
Title
Symbol-Digit Modalities Test (SDMT) (in subacute stroke survivors, Aim 3)
Description
Measure of the cognitive status in subacute stroke survivors
Time Frame
Change from baseline scores at post-intervention (after 5 weeks)
Title
Hopkins Verbal Learning Test (Revised) (in chronic stroke survivors, Aim 2)
Description
Measure of the cognitive status in chronic stroke survivors
Time Frame
Change from baseline scores at post-intervention (after 5 weeks)
Title
Hopkins Verbal Learning Test (Revised) (in subacute stroke survivors, Aim 3)
Description
Measure of the cognitive status in subacute stroke survivors
Time Frame
Change from baseline scores at post-intervention (after 5 weeks)
Title
2-minutes walk test (2mwt) (in chronic stroke survivors, Aim 2)
Description
Measure of the gait endurance in chronic stroke survivors
Time Frame
Change from baseline scores at post-intervention (after 5 weeks)
Title
2-minutes walk test (2mwt) (in subacute stroke survivors, Aim 3)
Description
Measure of the gait endurance in subacute stroke survivors
Time Frame
Change from baseline scores at post-intervention (after 5 weeks)
Title
Functional Gait Assessment (FGA) (in chronic stroke survivors, Aim 2)
Description
Measure of the gait mobility, balance and falls risks in chronic stroke survivors
Time Frame
Change from baseline scores at post-intervention (after 5 weeks)
Title
Functional Gait Assessment (FGA) (in subacute stroke survivors, Aim 3)
Description
Measure of the gait mobility, balance and falls risks in subacute stroke survivors
Time Frame
Change from baseline scores at post-intervention (after 5 weeks)
Title
12-Item Short Form Health Survey (SF-12) (in chronic stroke survivors, Aim 2)
Description
Self-reported measure of quality of life
Time Frame
Change from baseline scores at post-intervention (after 5 weeks)
Title
12-Item Short Form Health Survey (SF-12) (in subacute stroke survivors, Aim 3)
Description
Self-reported measure of quality of life
Time Frame
Change from baseline scores at post-intervention (after 5 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Fabara, MD
Phone
6179526336
Email
efabara@partners.org
First Name & Middle Initial & Last Name or Official Title & Degree
Gregory Schiurring, BS
Phone
6179526331
Email
gschiurring@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Bonato, PhD
Organizational Affiliation
Harvard Medical School (HMS and HSDM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spaulding Rehabilitation Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Bonato, PhD
Phone
617-952-6319
Email
pbonato@partners.org
First Name & Middle Initial & Last Name & Degree
Paolo Bonato, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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