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

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

Overview

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.

Detailed description

Stroke is a leading cause of long-term disability worldwide, and impaired walking capacity remains one of the most common and persistent limitations in the chronic phase. Although neurodevelopmental treatment (NDT) is widely used in clinical practice, current evidence emphasizes the role of training intensity and task-specific repetition in promoting locomotor recovery. However, comparative evidence regarding the relative effectiveness of high-repetition task-oriented training and high-intensity gait training as adjuncts to conventional therapy in chronic stroke is limited.

This study is designed as an assessor-blinded, three-arm, parallel-group randomized controlled trial. Forty-five individuals with chronic stroke will be randomly allocated in a 1:1:1 ratio to one of three groups (n=15 per group): (1) NDT alone, consisting of 45-minute sessions; (2) NDT combined with high-repetition task-oriented training; or (3) NDT combined with high-intensity gait training. In the combined groups, an additional 30 minutes of the respective training approach will be delivered in each session, resulting in approximately 75 minutes of total treatment time per session. All interventions will be delivered by a single experienced physiotherapist, 3 days per week for 8 weeks (24 sessions in total), at Bingöl State Hospital and the Faculty of Physiotherapy and Rehabilitation of Bingöl University.

The primary outcome is walking capacity assessed with the 6-Minute Walk Test. Secondary outcomes include the Timed Up and Go Test, the modified Dynamic Gait Index, and the 10-Meter Walk Test. All outcome measures will be administered at baseline and at the end of the 8-week intervention period by an independent assessor blinded to group allocation.

Data will be analyzed using repeated-measures analysis of variance to examine time-by-group interaction effects. The study is expected to provide comparative evidence to inform the selection of intensity-based adjunct training strategies in the rehabilitation of walking function in chronic stroke.

Interventions

• Other Neurodevelopmental Treatment
  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.
• Other High-Repetition Task-Oriented Training
  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.
• Other High-Intensity Gait Training
  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.

Primary outcome measures

• 6-Minute Walk Test (6MWT) [Time frame: 8 weeks]

Secondary outcome measures (2)

• Modified Dynamic Gait Index (mDGI) [Time frame: 8 weeks]
• 10-Meter Walk Test (10MWT) [Time frame: 8 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Bingol State Hospital - City: Bingöl, Country: Türkiye (listede "Turkey" olarak geçebilir) — Bingoel

Identifiers

NCT: NCT07725211 · BINGOL-FTR-2026-05-09

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗