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

Mass General Brigham

Status: Enrolling

Conditions: Stroke; Gait, Hemiplegic; Hemiplegia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04625127

2020P002544

Details and patient eligibility

About

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

Full 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.

Enrollment: 76 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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76 participants in 2 patient groups

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

Experimental group

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.

Treatment:

Device: Treadmill gait training with GaitBetter

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

Experimental group

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.

Treatment:

Other: Standard of care

Other: Treadmill gait training with GaitBetter + Standard of care