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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- 6-Minute Walk Test (6MWT)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
6-Minute Walk Test (6MWT)
时间窗: 8 weeks
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.
次要结局
- Modified Dynamic Gait Index (mDGI)(8 weeks)
- 10-Meter Walk Test (10MWT)(8 weeks)
研究者
Emrah Zirek
Assistant Professor
Bingol University