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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04625127
• Other study ID #: 2020P002544
• Status: Recruiting
• Phase: N/A
• Start date: July 23, 2021
• Est. completion date: May 2023

Study information

• Verified date: August 2022
• Source: Spaulding Rehabilitation Hospital
• Contact: Eric Fabara, MD
• Phone: 6179526336
• Email: efabara[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: May 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Gait, Hemiplegic
• Hemiplegia
• Stroke

Intervention

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.

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.
• 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.

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Hospital Boston	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital	GoldenGait LTD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Montreal Cognitive Assessment (MoCA) (in chronic stroke survivors, Aim 2)	Measure of the cognitive status in chronic stroke survivors	Change from baseline scores at post-intervention (after 5 weeks)
Other	Montreal Cognitive Assessment (MoCA) (in subacute stroke survivors, Aim 3)	Measure of the cognitive status in subacute stroke survivors	Change from baseline scores at post-intervention (after 5 weeks)
Other	Symbol-Digit Modalities Test (SDMT) (in subacute stroke survivors, Aim 2)	Measure of the cognitive status in chronic stroke survivors	Change from baseline scores at post-intervention (after 5 weeks)
Other	Symbol-Digit Modalities Test (SDMT) (in subacute stroke survivors, Aim 3)	Measure of the cognitive status in subacute stroke survivors	Change from baseline scores at post-intervention (after 5 weeks)
Other	Hopkins Verbal Learning Test (Revised) (in chronic stroke survivors, Aim 2)	Measure of the cognitive status in chronic stroke survivors	Change from baseline scores at post-intervention (after 5 weeks)
Other	Hopkins Verbal Learning Test (Revised) (in subacute stroke survivors, Aim 3)	Measure of the cognitive status in subacute stroke survivors	Change from baseline scores at post-intervention (after 5 weeks)
Other	2-minutes walk test (2mwt) (in chronic stroke survivors, Aim 2)	Measure of the gait endurance in chronic stroke survivors	Change from baseline scores at post-intervention (after 5 weeks)
Other	2-minutes walk test (2mwt) (in subacute stroke survivors, Aim 3)	Measure of the gait endurance in subacute stroke survivors	Change from baseline scores at post-intervention (after 5 weeks)
Other	Functional Gait Assessment (FGA) (in chronic stroke survivors, Aim 2)	Measure of the gait mobility, balance and falls risks in chronic stroke survivors	Change from baseline scores at post-intervention (after 5 weeks)
Other	Functional Gait Assessment (FGA) (in subacute stroke survivors, Aim 3)	Measure of the gait mobility, balance and falls risks in subacute stroke survivors	Change from baseline scores at post-intervention (after 5 weeks)
Other	12-Item Short Form Health Survey (SF-12) (in chronic stroke survivors, Aim 2)	Self-reported measure of quality of life	Change from baseline scores at post-intervention (after 5 weeks)
Other	12-Item Short Form Health Survey (SF-12) (in subacute stroke survivors, Aim 3)	Self-reported measure of quality of life	Change from baseline scores at post-intervention (after 5 weeks)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)	Change from baseline scores at post-intervention (after 5 weeks)
Secondary	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)	Change from baseline scores at post-intervention (after 5 weeks)
Secondary	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)	Change from baseline scores at post-intervention (after 5 weeks)
Secondary	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)	Change from baseline scores at post-intervention (after 5 weeks)
Secondary	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)	Change from baseline scores at post-intervention (after 5 weeks)
Secondary	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)	Change from baseline scores at post-intervention (after 5 weeks)
Secondary	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)	Change from baseline scores at post-intervention (after 5 weeks)
Secondary	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)	Change from baseline scores at post-intervention (after 5 weeks)
Secondary	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)	Change from baseline scores at post-intervention (after 5 weeks)
Secondary	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)	Change from baseline scores at post-intervention (after 5 weeks)