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NCT07725211
Task-Oriented Training Versus High-Intensity Gait Training in People With Chronic Stroke
Conditions: Stroke, Hemiplegia, Chronic Stroke
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 45
Sponsor: Istanbul University - Cerrahpasa
Location: Bingol State Hospital - City: Bingöl, Country: Türkiye (listede "Turkey" olarak geçebilir), Zip: 12000 Bingoel Center
Summary
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
Inclusion Criteria:
* 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
* Functional Ambulation Category (FAC) score of 3 or higher
* Sufficient cognitive ability to understand and follow instructions (Mini-Mental State Examination score ≥ 24)
* Willingness to participate and provision of written informed consent
Exclusion Criteria:
* 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
* Severe visual or vestibular impairment
* Severe aphasia or cognitive impairment preventing participation in training or assessments
* Participation in another structured rehabilitation or exercise program during the study period
* Botulinum toxin injection to the lower extremity within the last 6 months
Source: ClinicalTrials.gov (NCT07725211). StuddyBuddy aggregates publicly available trial information.