Status:
WITHDRAWN
High Vs Low Intensity Virtual Reality Gait Training in Individuals with Chronic Stroke
Lead Sponsor:
Indiana University
Conditions:
Stroke
Gait Disorders, Neurologic
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The purpose of this pilot study is to investigate the feasibility of 1) providing virtual reality walking training using a custom developed setup able to be replicated in routine clinical practice and...
Detailed Description
This study will utilize a randomized-crossover design. Following confirmation of eligibility and completion of Baseline 1 testing, individuals will be randomized to receive up to 15 visits over approx...
Eligibility Criteria
Inclusion
- Unilateral deficits following stroke \> 6 months prior; however individuals \> 4 months post-stroke are eligible for consenting, but final eligibility and potential enrollment will not occur until \> 6 months
- Age 18-85 years
- Weight \< 350 pounds
- Able to follow a 3-step command
- Able to ambulate with self-selected gait speeds between 0.01-1.0 m/s without physical assistance, but with below knee bracing and/or assistive device as needed
- Lower extremity Fugl-Meyer \< 34
- Medical clearance to participate
Exclusion
- Evidence of cerebellar ataxia
- Uncontrolled cardiopulmonary or metabolic disease that limits exercise participation, active heterotopic ossification, recurrent history of lower extremity fractures, previous orthopedic or other peripheral or central neurologic injury that may impair locomotor activities
- Currently participating in other physical therapy
- \> 50 units of Botox in the lower extremity OR in the lower extremity, but above the knee if the participant wears an ankle-foot-orthosis (AFO) within the past three months. Note that participants may be consented prior to 3 months post-injection; however, eligibility will be determined post 3 months.
- Unable to read \> 50% of the letters on the 20/70 line of the Snellen Chart with customary eye wear at a distance of 20 feet
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06522477
Start Date
November 1 2024
End Date
June 30 2026
Last Update
October 18 2024
Active Locations (1)
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1
Rehabilitation Hospital of Indiana
Indianapolis, Indiana, United States, 46254