GaitBetter: Motor and Cognitive Training for Gait Rehabilitation and Falls Prevention in Stroke Survivors.
NCT04625127 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76
Last updated 2026-04-02
Summary
In this research study, the investigators aim to test the usability and efficacy of the GaitBetter system for gait rehabilitation after stroke.
Conditions
- Stroke
- Gait, Hemiplegic
- Hemiplegia
Interventions
- 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.
Sponsors & Collaborators
-
GoldenGait LTD
collaborator UNKNOWN -
Spaulding Rehabilitation Hospital
lead OTHER
Principal Investigators
-
Paolo Bonato, PhD · Harvard Medical School (HMS and HSDM)
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-07-23
- Primary Completion
- 2026-05-31
- Completion
- 2026-05-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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