GaitBetter: Motor and Cognitive Training for Gait Rehabilitation and Falls Prevention in Stroke Survivors.
NCT ID: NCT04625127
Last Updated: 2022-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
76 participants
INTERVENTIONAL
2021-07-23
2023-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Aim 2: Efficacy of the GaitBetter to improve motor-cognitive function of chronic stroke survivors
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.
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.
Aim 3: Efficacy of the GaitBetter to improve rehabilitation outcomes in sub-acute stroke survivors
The investigators propose a randomized, controlled study to evaluate the effects of using the GaitBetter system in patients with subacute stroke on recovery trajectory.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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GoldenGait LTD
UNKNOWN
Spaulding Rehabilitation Hospital
OTHER
Responsible Party
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Paolo Bonato
Principal Investigator, Director of the Motion Analysis Laboratory
Principal Investigators
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Paolo Bonato, PhD
Role: PRINCIPAL_INVESTIGATOR
Harvard Medical School (HMS and HSDM)
Locations
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Spaulding Rehabilitation Hospital Boston
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020P002544
Identifier Type: -
Identifier Source: org_study_id
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