Status:
RECRUITING
High vs Low-frequency of High-intensity Training in Chronic Stroke
Lead Sponsor:
Indiana University
Conditions:
Stroke
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The purpose of this pilot study is to investigate the potential role of training frequency on locomotor outcomes following high-intensity gait training and provision of a home walking program.
Detailed Description
This study will utilize a 2 arm randomized trial to investigate potential differences in locomotor and community outcomes following 18 visits of high-intensity gait training provided over 6 weeks (hig...
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
- Weight \< 350 pounds
- Able to follow 3-step commands
- Able to ambulate with self-selected gait speeds between 0.10-1.0 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 such that, in the judgement of the PI, could compromise the safety of the participant, limit the ability to complete the study, or compromise the objectives of the study.
- 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
Key Trial Info
Start Date :
September 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06612723
Start Date
September 16 2024
End Date
October 1 2026
Last Update
December 17 2024
Active Locations (1)
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1
Rehabilitation Hospital of Indiana
Indianapolis, Indiana, United States, 46254