About this trial
The purpose of this study is to compare the effects of high-repetition task-oriented training and high-intensity gait training on walking capacity and functional mobility in individuals with chronic stroke.
Forty-five participants will be randomly assigned to one of three groups: (1) neurodevelopmental treatment (NDT) alone, (2) NDT combined with high-repetition task-oriented training, or (3) NDT combined with high-intensity gait training. All participants will receive treatment 3 days per week for 8 weeks (24 sessions in total). Walking capacity (6-Minute Walk Test) and functional mobility (Timed Up and Go Test, modified Dynamic Gait Index, 10-Meter Walk Test) will be assessed before and after the intervention by an assessor blinded to group allocation. The study hypothesizes that adding structured, intensity-based training approaches to conventional NDT will lead to greater improvements in walking capacity than NDT alone.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of first-ever unilateral stroke (ischemic or hemorrhagic) confirmed by clinical and/or radiological findings
Time since stroke onset of at least 6 months (chronic phase)
Age between 18 and 75 years
Ability to walk at least 10 meters independently, with or without an assistive device
Disqualifiers
Recurrent stroke or bilateral hemispheric involvement
Unstable cardiovascular disease or other medical conditions contraindicating high-intensity exercise
Severe lower extremity spasticity interfering with gait training (Modified Ashworth Scale score > 3)
Orthopedic, rheumatological, or other neurological conditions affecting gait
Trial design
Parallel
Treatments tested in this trial
Neurodevelopmental Treatment
Other interventionConventional neurodevelopmental treatment delivered in 45-minute sessions, 3 days per week for 8 weeks, focusing on postural control, weight transfer, selective movement of the lower extremity, and facilitation of normal movement patterns. All sessions will be delivered by a single experienced physiotherapist.
High-Repetition Task-Oriented Training
Other interventionStructured, task-specific lower extremity training performed at high repetition volumes for 30 minutes per session, in addition to neurodevelopmental treatment. Training includes functional tasks such as sit-to-stand, stepping, and weight-shifting activities, with the number of repetitions and task difficulty progressed individually based on participant performance.
High-Intensity Gait Training
Other interventionWalking-based training performed for 30 minutes per session at high aerobic intensity, in addition to neurodevelopmental treatment. Training intensity will be progressively adjusted and monitored using target heart rate and ratings of perceived exertion.
Treatment groups
Trial outcomes
Primary outcomes
6-Minute Walk Test (6MWT)
The 6-Minute Walk Test measures the distance (in meters) a participant can walk in 6 minutes along a standardized walkway. Greater distance indicates better walking capacity. The test will be administered by an assessor blinded to group allocation.
Secondary outcomes
Modified Dynamic Gait Index (mDGI)
The modified Dynamic Gait Index evaluates the ability to modify gait in response to changing task demands across 8 tasks, each scored on three facets (time, level of assistance, and gait pattern). Total scores range from 0 to 64, with higher scores indicating better dynamic gait performance.
10-Meter Walk Test (10MWT)
The 10-Meter Walk Test measures gait speed (in meters per second) over a 10-meter distance. Higher speed indicates better walking performance.
Sponsors and contacts
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Istanbul University - Cerrahpasa
Lead sponsor
Bingol University
Sponsor institution
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