NCT04625127

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Spaulding Rehabilitation Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke
• Gait, Hemiplegic
• Hemiplegia

Interventions

Type	Name	Description
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.
OTHER	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.

Timeline

• Start date: 2021-07-23
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2020-11-12
• Last updated: 2026-04-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study