Task-Oriented Training Versus High-Intensity Gait Training in People With Chronic Stroke

NCT07725211 | Not Yet Recruiting

• 1 other identifier: BINGOL-FTR-2026-05-09
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Hemiplegia; Chronic Stroke

Keywords

Task-oriented training; High-intensity gait training; Neurodevelopmental treatment; Walking capacity; Gait rehabilitation; Functional mobility; 6-Minute Walk Test; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (2)

• Modified Dynamic Gait Index (mDGI)

  8 weeks

• 10-Meter Walk Test (10MWT)

  8 weeks

Study Arms (3)

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 Training

EXPERIMENTAL

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 Training

EXPERIMENTAL

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

Interventions

Neurodevelopmental Treatment OTHER

Conventional 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.

Also known as: NDT

Group 1: Neurodevelopmental Treatment (NDT)

High-Repetition Task-Oriented Training OTHER

Structured, 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.

Also known as: HRTOT

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

High-Intensity Gait Training OTHER

Walking-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.

Also known as: HIGT

Group 3: NDT + High-Intensity Gait Training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Bingol State Hospital - City: Bingöl, Country: Türkiye (listede "Turkey" olarak geçebilir), Zip: 12000

Bingoel, Center, 12000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Emrah Zirek, Ph. D.

CONTACT

+904262160012; zireke@gmail.com

Samet Tatli, MD

CONTACT

+905XXXXXXXXX; drsamettatli@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All outcome assessments will be performed by an independent assessor who is blinded to group allocation and not involved in the delivery of the interventions. Due to the nature of the exercise-based interventions, participants and the treating physiotherapist cannot be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)