Bimanual Training Versus Unilateral Task Specific Training in Children With Spastic Hemiplegic Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change in Upper Limb Spasticity Measured by Modified Ashworth Scale (MAS)
研究概览
简要总结
Cerebral palsy is one of the most common childhood neurological disorders and often results in weakness, poor coordination, and stiffness (spasticity) in one side of the body in children with spastic hemiplegic cerebral palsy. These difficulties can significantly affect a child's ability to perform daily activities such as dressing, eating, playing, and school-related tasks.
Upper limb rehabilitation plays a crucial role in improving independence and quality of life in these children. Two commonly used rehabilitation approaches are bimanual training, which focuses on using both hands together during functional tasks, and unilateral task-specific training, which focuses intensively on improving the affected hand through repetitive, goal-directed activities.
Although both approaches are widely practiced in pediatric neurorehabilitation, there is limited direct comparison of their effectiveness in reducing spasticity and improving functional independence among children with spastic hemiplegic cerebral palsy, particularly in the local population of Pakistan.
This randomized controlled trial aims to compare the effectiveness of bimanual training versus unilateral task-specific training in children aged 5-12 years diagnosed with spastic hemiplegic cerebral palsy. A total of 46 participants will be randomly assigned to one of two intervention groups. Both groups will receive therapy three times per week for eight weeks.
Spasticity will be measured using the Modified Ashworth Scale (MAS), and functional independence will be assessed using the Pediatric Evaluation of Disability Inventory (PEDI). Assessments will be conducted before and after the intervention period.
The results of this study may help clinicians, caregivers, and rehabilitation centers determine which therapy approach is more effective in improving upper limb function and independence in children with spastic hemiplegic cerebral palsy. Participation in this study is voluntary, and children may withdraw at any time without affecting their standard care.
详细描述
Study Design
This study is a randomized controlled trial (RCT) designed to compare the effectiveness of bimanual training and unilateral task-specific training on spasticity and functional independence in children with spastic hemiplegic cerebral palsy.
Study Setting and Duration
Data will be collected from Sukkur Institute of Nursing and Allied Health Sciences, Blood Bank Hospital Sukkur, and Hidayat Physiotherapy and Rehabilitation Center. The study duration will be nine months following approval of the synopsis.
Sample Size
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)
入排标准
- 年龄范围
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both male and female Children diagnosed with spastic hemiplegic cerebral palsy (confirmed by a pediatric neurologist or rehabilitation specialist).
- •Age range: 5 to 12 years (suitable for both bimanual and unilateral task-specific training).
- •Gross Motor Function Classification System (GMFCS) levels I to III (ambulatory with or without limitations).
- •Modified Ashworth Scale score between 1 and 3 in the upper limb muscles (indicating mild to moderate spasticity).
- •Minimum cognitive ability to follow simple instructions, verified using screening tools (e.g., MMSE adapted for children).
- •Ability to sit unsupported for at least 30 seconds (to ensure safe participation in therapy).
排除标准
- •Children with mixed types of cerebral palsy (e.g., spastic quadriplegia, dyskinetic, or ataxic types).
- •Recent orthopedic surgery or botulinum toxin injections in the affected upper limb within the past 6 months.
- •Severe visual, auditory, or sensory deficits that could interfere with therapy participation or assessment accuracy.
- •Uncontrolled epilepsy or other neurological conditions that could compromise safety during therapy.
- •Fixed joint contractures or severe deformities in the upper limbs that limit passive range of motion Children with behavioral or psychological disorders (e.g., severe ADHD, autism spectrum disorder) that impair attention or participation
研究组 & 干预措施
group A Bimanual Training Group
Participants in this group will receive structured bimanual training designed to improve coordination, reduce spasticity, and enhance functional use of both upper limbs. The intervention will be delivered three sessions per week for 8 weeks, with each session lasting 60 minutes. Activities will include repetitive, goal-directed bilateral tasks such as buttoning shirts, folding clothes, opening containers, building with blocks, and bimanual play activities. Each session will be divided into three 20-minute activity blocks with 5-minute rest intervals to prevent fatigue. All sessions will be supervised by a certified pediatric physiotherapist trained in neurorehabilitation. In addition, participants will receive standardized baseline physiotherapy education at the start of the study.
干预措施: Bimanual Training (Behavioral)
group B Unilateral Task-Specific Training Group
Participants in this group will receive unilateral task-specific training focused on intensive use of the affected upper limb to promote neuroplasticity and functional recovery. The intervention will be delivered three sessions per week for 8 weeks, with each session lasting 60 minutes. Activities will include grasp-and-release exercises, reaching, stacking, drawing, flipping cards, and manipulation of objects using the affected hand. The unaffected hand may be mildly restrained when necessary to encourage active use of the affected limb without causing frustration. Sessions will be structured into three 20-minute blocks with 5-minute rest intervals. Standardized baseline physiotherapy education will also be provided at the beginning of the study.
干预措施: Unilateral Task-Specific Training (Behavioral)
结局指标
主要结局
Change in Upper Limb Spasticity Measured by Modified Ashworth Scale (MAS)
时间窗: Baseline (Week 0) mid week(4), Post-intervention (Week 8)
Spasticity will be assessed using the Modified Ashworth Scale (MAS), a standardized clinical tool used to measure velocity-dependent resistance to passive muscle stretch. The MAS grades muscle tone on a scale from 0 to 4, with higher scores indicating greater spasticity. Upper limb muscle groups (including elbow flexors, wrist flexors, and finger flexors) will be evaluated by trained physiotherapists. The primary outcome will be the change in MAS score from baseline to post-intervention, comparing the effectiveness of bimanual training versus unilateral task-specific training in reducing spasticity.
次要结局
未报告次要终点
研究者
Montiha Azeem
principal investigator
University of Lahore