Robot-assisted Versus Conventional Physical Therapy for Hand in Sub-acute Stroke (ROCHAS)
This randomized controlled trial aims to compare the effectiveness of robotic-assisted physiotherapy and conventional physiotherapy in improving hand function among patients with sub-acute stroke. Stroke often results in weakness, reduced hand strength, impaired dexterity, and difficulty performing daily activities due to upper-limb motor dysfunction. Early rehabilitation targeting hand recovery is essential to improve independence and quality of life.
A total of 30 participants with sub-acute post-stroke spastic hemiplegia will be recruited from the University of Lahore Hospital and randomly assigned into two groups. The intervention group will receive robotic-assisted physiotherapy focused on repetitive, task-specific wrist and finger extension training using a robotic hand/wrist device, while the control group will receive conventional therapist-led upper-limb rehabilitation exercises. Both groups will undergo treatment sessions lasting 30-45 minutes, five days per week for four weeks.
Outcome measures will include hand muscle strength assessed using a hand-held dynamometer, hand dexterity evaluated through the Action Research Arm Test (ARAT), and functional improvement measured using the Fugl-Meyer Assessment for Upper Extremity (FMA-UE). Additional measures such as spasticity, activities of daily living, and quality of life will also be recorded. Assessments will be conducted at baseline, during treatment, and after completion of the intervention period by a blinded assessor.
The study is expected to determine whether robotic-assisted physiotherapy provides greater improvements in hand strength, dexterity, and upper-limb functional recovery compared to conventional physiotherapy in individuals recovering from stroke. Findings from this research may contribute to evidence-based rehabilitation strategies for improving upper-limb outcomes after stroke.
研究概览
地位
详细说明
Stroke is one of the leading causes of long-term disability worldwide and frequently results in upper-limb impairments that significantly affect independence and quality of life. Hand dysfunction, including reduced grip strength, poor dexterity, impaired coordination, and difficulty performing functional tasks, is common during the sub-acute phase following stroke. Recovery of hand and upper-limb function is considered a major goal of neurorehabilitation because deficits in grasping, object manipulation, and coordinated movement restrict performance of activities of daily living and social participation.
Conventional physiotherapy remains a widely used rehabilitation approach for upper-limb recovery after stroke. It typically involves therapist-guided range-of-motion exercises, strengthening, task-oriented training, neuromuscular facilitation, and functional retraining techniques. Although beneficial, conventional therapy may be limited by therapist fatigue, reduced intensity of repetitions, and variability in treatment delivery. Emerging rehabilitation technologies such as robotic-assisted physiotherapy have been introduced to overcome these limitations by providing high-intensity, repetitive, task-specific, and feedback-driven training that may enhance neuroplasticity and motor relearning.
Robotic-assisted physiotherapy allows patients to perform repeated wrist and finger movements with adjustable assistance or resistance while receiving visual or sensory feedback. These systems can increase the number of movement repetitions, promote active participation, and objectively monitor patient performance. Previous studies have suggested that robotic rehabilitation may improve motor control, muscle strength, and functional outcomes in stroke survivors; however, evidence comparing robotic-assisted therapy with conventional physiotherapy specifically for hand recovery in sub-acute stroke patients remains limited.
This randomized controlled trial will compare robotic-assisted physiotherapy with conventional physiotherapy for improving hand function in individuals with sub-acute stroke. Thirty participants meeting the eligibility criteria will be recruited from the University of Lahore Hospital and randomly allocated into two equal groups using the sealed-envelope randomization method. Group A will receive robotic-assisted physiotherapy targeting wrist and finger extension through repetitive, task-specific robotic training combined with visual feedback and progressive assistance or resistance. Group B will receive conventional physiotherapy consisting of active-assisted and resistive exercises, task-oriented training, neuromuscular facilitation, mirror therapy, and activities of daily living training. Both groups will receive treatment five days per week for four weeks, with each session lasting approximately 30-45 minutes.
Primary outcomes will include hand muscle strength measured by a hand-held dynamometer, hand dexterity assessed using the Action Research Arm Test (ARAT), and upper-limb functional recovery measured through the Fugl-Meyer Assessment for Upper Extremity (FMA-UE). Secondary outcomes will include spasticity using the Modified Ashworth Scale, activities of daily living using the Modified Barthel Index, and quality of life using the EQ-5D questionnaire. Outcome assessments will be performed at baseline, midpoint, and post-intervention by a blinded assessor using standardized protocols.
The findings of this study may help determine whether robotic-assisted physiotherapy offers superior benefits over conventional physiotherapy for hand rehabilitation in sub-acute stroke patients. The results may contribute to the development of evidence-based rehabilitation protocols and support the integration of advanced robotic technologies into stroke rehabilitation programs to optimize upper-limb recovery and functional independence.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Punjab Province
-
Lahore、Punjab Province、巴基斯坦、54000
- University of Lahore teaching hospital, Lahore
-
-
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Both male and female adults aged 30-50 years diagnosed with post-stroke spastic hemiplegia confirmed by a neurologist.
- Stroke duration 2 weeks to 6 months (sub acute stage) with medically stable condition.
- Presence of mild to moderate upper-limb spasticity using screening test(Modified Ashworth Scale score 1-3).
- Ability to comprehend and follow simple verbal instructions using screening test (MMSE ≥ 24).
Exclusion Criteria:
- No history of upper-limb orthopedic surgery or botulinum toxin injections in the last 6 months.
- History of recurrent or uncontrolled seizure disorders, progressive neurological diseases, or unstable cardiovascular conditions.
- Participation in any intensive upper-limb rehabilitation program (CIMT, bimanual training, task-specific training, robotic therapy, FES therapy) within the past 6 months.
- Comorbid conditions affecting upper-limb function (fractures, severe arthritis, peripheral nerve injuries).
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:group A Robotic-Assisted Physiotherapy Group
Participants in this group will receive robotic-assisted physiotherapy focused on wrist and finger extension training using a robotic hand/wrist rehabilitation device.
Treatment will include repetitive task-specific movements, active-assist and active-resist exercises, visual feedback tasks, and functional grasp-release training.
Sessions will be conducted for 30-45 minutes per session, 5 days per week for 4 weeks under therapist supervision.
|
Participants will receive robotic-assisted hand rehabilitation using a robotic hand/wrist training device designed to improve wrist and finger extension, hand coordination, and functional upper-limb recovery after stroke.
The intervention will include repetitive task-specific movements, active-assist and active-resist training, grasp-release exercises, visual feedback activities, and functional motor practice supervised by a physiotherapist.
Treatment intensity and robotic assistance will be progressively adjusted according to patient performance and recovery level.
Sessions will last 30-45 minutes, 5 days per week for 4 weeks.
|
|
有源比较器:group B Conventional Physiotherapy Group
Participants in this group will receive conventional therapist-led upper-limb rehabilitation consisting of active-assisted and active range-of-motion exercises, strengthening exercises for wrist and finger extensors, task-oriented functional training, neuromuscular facilitation, mirror therapy, and activities of daily living training.
Sessions will be conducted for 30-45 minutes per session, 5 days per week for 4 weeks.
|
Participants will receive conventional physiotherapy focused on upper-limb rehabilitation after stroke.
The treatment program will include active-assisted and active range-of-motion exercises, strengthening exercises for wrist and finger extensors, task-specific functional training, neuromuscular facilitation techniques, mirror therapy, and activities of daily living practice.
Exercise intensity and task difficulty will be progressively increased according to patient ability and motor recovery.
Sessions will last 30-45 minutes, 5 days per week for 4 weeks under physiotherapist supervision.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Upper Limb Motor Function Using Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
大体时间:Baseline and after 4 weeks of intervention
|
The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) will be used to evaluate motor recovery and functional improvement of the affected upper limb in participants with sub-acute stroke.
The assessment includes evaluation of reflexes, movement synergy, wrist control, hand function, and coordination.
Higher scores indicate better upper-limb motor performance and recovery.
|
Baseline and after 4 weeks of intervention
|
合作者和调查者
调查人员
- 首席研究员:Muhammad Uzair, MSPTN、The University of Lahore, Lahore
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.