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NCT07725211

Overview

NCT ID: NCT07725211
Lead Sponsor: Istanbul University - CerrahpasaOTHER
Official Title: High-Repetition Task-Oriented Training Versus High-Intensity Gait Training for Lower Extremity Rehabilitation in Individuals With Chronic Stroke: An Assessor-Blinded Randomized Controlled Trial
Brief 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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 24, 2026Actual
Start Date: Aug 15, 2026Estimated
Primary Completion Date: Dec 15, 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 45Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: Emrah Zirek, Ph. D.Contact
zireke@gmail.com+904262160012

Similar Studies

Participant Group/Arms

Group 1: Neurodevelopmental Treatment (NDT)Active Comparator

Participants will receive neurodevelopmental treatment alone, delivered in 45-minute sessions, 3 days per week for 8 weeks (24 sessions in total).

Other: Neurodevelopmental Treatment

Group 2: NDT + High-Repetition Task-Oriented TrainingExperimental

Participants will receive 45 minutes of neurodevelopmental treatment followed by 30 minutes of high-repetition task-oriented training targeting the lower extremity in each session (approximately 75 minutes in total), 3 days per week for 8 weeks (24 sessions in total).

Other: High-Repetition Task-Oriented Training

Group 3: NDT + High-Intensity Gait TrainingExperimental

Participants will receive 45 minutes of neurodevelopmental treatment followed by 30 minutes of high-intensity gait training in each session (approximately 75 minutes in total), 3 days per week for 8 weeks (24 sessions in total).

Other: High-Intensity Gait Training