High vs Low-frequency of High-intensity Training in Chronic Stroke
- Conditions
- Stroke
- Interventions
- Other: high-intensity gait trainingBehavioral: Physical activity coaching
- Registration Number
- NCT06612723
- Lead Sponsor
- Indiana University
- 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 (high frequency) or 12 weeks (low frequency). Following confirmation of eligibility and baseline testing, individuals will be randomized to either high or low frequency of training and complete subsequent testing at 6 weeks, 12 weeks, and 24 weeks.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High frequency high-intensity gait training Individuals will receive up to 18 visits of high-intensity gait training and activity coaching over 6 weeks High frequency Physical activity coaching Individuals will receive up to 18 visits of high-intensity gait training and activity coaching over 6 weeks Low frequency high-intensity gait training Individuals will receive up to 18 visits of high-intensity gait training and activity coaching over 12 weeks Low frequency Physical activity coaching Individuals will receive up to 18 visits of high-intensity gait training and activity coaching over 12 weeks
- Primary Outcome Measures
Name Time Method 6-minute walk test After 12 weeks Individuals will be asked to "cover as much ground as possible" over 6 mins. Heart rate will additionally be measured during this assessment (distance in m)
- Secondary Outcome Measures
Name Time Method Peak treadmill speed After 12 weeks Individuals will participate in a walking-based graded exercise test. While harnessed for safety, a motorized treadmill will be initially set to 0.1 m/s and increased by 0.1 m/s each minute until the test is terminated due: 1) requests to stop, 2) unable to keep up with the treadmill and/or loses their balance, 3) absolute exercise test termination criteria provided by ACSM. The highest speed that the individual can walk for a minute at is the peak treadmill speed.
Trial Locations
- Locations (1)
Rehabilitation Hospital of Indiana
🇺🇸Indianapolis, Indiana, United States