Clinical trial NCT04625127: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Gait, Hemiplegic
Hemiplegia
Keywords: Stroke
Gait
Falls
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: GoldenGait LTD
First posted: 2020-11-12
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 10 meter walk test (in chronic stroke survivors, Aim 2)
timeFrame: Change from baseline scores at post-intervention (after 5 weeks)
measure: 10 meter walk test (in subacute stroke survivors, Aim 3)
timeFrame: Change from baseline scores at post-intervention (after 5 weeks)
measure: Trail making test (in chronic stroke survivors, Aim 2)
timeFrame: Change from baseline scores at post-intervention (after 5 weeks)
measure: Trail making test (in subacute stroke survivors, Aim 3)
timeFrame: Change from baseline scores at post-intervention (after 5 weeks)
measure: Balance Evaluation Systems Test (mini-BESTest, in chronic stroke survivors, Aim 2)
timeFrame: Change from baseline scores at post-intervention (after 5 weeks)
measure: Aim 3: Balance Evaluation Systems Test (mini-BESTest, in subacute stroke survivors, Aim 3)
timeFrame: Change from baseline scores at post-intervention (after 5 weeks)
Secondary outcomes:
measure: Step length (in chronic stroke survivors, Aim 2)
timeFrame: Change from baseline scores at post-intervention (after 5 weeks)
measure: Step length (in subacute stroke survivors, Aim 3)
timeFrame: Change from baseline scores at post-intervention (after 5 weeks)
measure: Step width (in chronic stroke survivors, Aim 2)
timeFrame: Change from baseline scores at post-intervention (after 5 weeks)
measure: Step width (in subacute stroke survivors, Aim 3)
timeFrame: Change from baseline scores at post-intervention (after 5 weeks)
measure: Step symmetry (in chronic stroke survivors, Aim 2)
timeFrame: Change from baseline scores at post-intervention (after 5 weeks)
measure: Step symmetry (in subacute stroke survivors, Aim 3)
timeFrame: Change from baseline scores at post-intervention (after 5 weeks)
measure: Stance time (in chronic stroke survivors, Aim 2)
timeFrame: Change from baseline scores at post-intervention (after 5 weeks)
measure: Stance time (in subacute stroke survivors, Aim 3)
timeFrame: Change from baseline scores at post-intervention (after 5 weeks)
measure: Swing time (in chronic stroke survivors, Aim 2)
timeFrame: Change from baseline scores at post-intervention (after 5 weeks)
measure: Swing time (in subacute stroke survivors, Aim 3)
timeFrame: Change from baseline scores at post-intervention (after 5 weeks)
Other outcomes:
measure: Montreal Cognitive Assessment (MoCA) (in chronic stroke survivors, Aim 2)
timeFrame: Change from baseline scores at post-intervention (after 5 weeks)
measure: Montreal Cognitive Assessment (MoCA) (in subacute stroke survivors, Aim 3)
timeFrame: Change from baseline scores at post-intervention (after 5 weeks)
measure: Symbol-Digit Modalities Test (SDMT) (in subacute stroke survivors, Aim 2)
timeFrame: Change from baseline scores at post-intervention (after 5 weeks)
measure: Symbol-Digit Modalities Test (SDMT) (in subacute stroke survivors, Aim 3)
timeFrame: Change from baseline scores at post-intervention (after 5 weeks)
measure: Hopkins Verbal Learning Test (Revised) (in chronic stroke survivors, Aim 2)
timeFrame: Change from baseline scores at post-intervention (after 5 weeks)
measure: Hopkins Verbal Learning Test (Revised) (in subacute stroke survivors, Aim 3)
timeFrame: Change from baseline scores at post-intervention (after 5 weeks)
measure: 2-minutes walk test (2mwt) (in chronic stroke survivors, Aim 2)
timeFrame: Change from baseline scores at post-intervention (after 5 weeks)
measure: 2-minutes walk test (2mwt) (in subacute stroke survivors, Aim 3)
timeFrame: Change from baseline scores at post-intervention (after 5 weeks)
measure: Functional Gait Assessment (FGA) (in chronic stroke survivors, Aim 2)
timeFrame: Change from baseline scores at post-intervention (after 5 weeks)
measure: Functional Gait Assessment (FGA) (in subacute stroke survivors, Aim 3)
timeFrame: Change from baseline scores at post-intervention (after 5 weeks)
measure: 12-Item Short Form Health Survey (SF-12) (in chronic stroke survivors, Aim 2)
timeFrame: Change from baseline scores at post-intervention (after 5 weeks)
measure: 12-Item Short Form Health Survey (SF-12) (in subacute stroke survivors, Aim 3)
timeFrame: Change from baseline scores at post-intervention (after 5 weeks)
Locations:
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital Boston
state: Massachusetts
Study officials:
affiliation: Harvard Medical School (HMS and HSDM)
name: Paolo Bonato, PhD
role: PRINCIPAL_INVESTIGATOR
References: