NCT07534228进行中（未招募）不适用
Play-based Therapy Versus Neurodevelopmental Therapy in Children With Diplegic Cerebral Palsy
University of Lahore1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年8月31日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Peabody Developmental Motor Scales (PDMS-2)
研究概览
简要总结
To compare the efficacy of play-based therapy versus NDT in improving fine motor skills in children with Spastic Diplegic Cerebral Palsy.
Baseline Assessments (Pre-Intervention) To Establish baseline motor function, balance, and goals.
- Standardized Tools (Conducted in Week 1):
- Peabody Developmental Motor Scales (PDMS-2): Evaluate gross and fine motor skills.
- Modified Ashworth Scale: Assess spasticity in lower and upper limbs.
- Pediatric Balance Scale (PBS): Measure static and dynamic balance.
- Parent/Child Goal Setting: Identify individualized goals (e.g., stair climbing, dressing independence).
1. Play-Based Therapy (PBT)
- 5-Minute Warm-Up: Gentle play (e.g., rolling a ball, stretching with ribbons)
- Building Blocks: Focus on fine motor control, bilateral coordination, and problem-solving.
- Puzzles: Enhance spatial awareness, grip strength, and cognitive engagement.
- Arts and Crafts: Promote hand-eye coordination (e.g., cutting, drawing) and creativity.
- Frequency: 4 days a week, for 3 consecutive weeks
- Intensity: Moderate effort; tasks tailored to the child's skill level (e.g., 5 piece puzzles progressing to 10-piece).
- Time: 45-minute sessions (30 minutes active play, 10 minutes rest/reinforcement). 2. Neurodevelopmental Therapy (NDT)
- 5-Minute Warm-Up: Light mobility exercises (e.g., Hand pumps, seated marching).
- Resistance Bands: Strengthen upper limbs (e.g. Bicep curls, shoulder abduction, chest presses.).
- Small Dumbbells: Improve upper body strength (1-2 lbs for shoulder/arm exercises).
- Stress Ball Squeezes: Enhance grip strength and hand function (5-10 reps/session).
- Frequency: 4 days a week, for 3 consecutive weeks
- Intensity: Moderate resistance; emphasize alignment and controlled movement
- Time: 40-minute sessions (30 minutes active exercise, 10 minutes rest/feedback). Outcome Measures
- Peabody Developmental Motor Scales (PDMS-2): for evaluating fine motor skills.
- Modified Ashworth Scale (MAS): To measure muscle spasticity (tone) in the limbs.
- CHQ: To measure health-related quality of life
详细描述
To compare the efficacy of play-based therapy versus NDT in improving fine motor skills in children with Spastic Diplegic Cerebral Palsy.
Inclusion Criteria
- Confirmed medical diagnosis of spastic diplegic cerebral palsy by a healthcare professional.
- Children aged between 8 to 12 years old (Raipure, Kovela, & Harjpal, 2023).
- Documented difficulties in fine motor skills, assessed by a standardized motor skills evaluation tool.
- Ability to understand and follow instructions, with or without assistance, to participate in the therapy sessions.
- Written informed consent from parents or legal guardians, allowing the child to participate in the study. Exclusion Criteria
- Presence of any other significant medical condition that might interfere
- Diagnosis of other forms of cerebral palsy (e.g., hemiplegic, quadriplegic).(Raipure et al., 2023).
- Severe cognitive impairments that would prevent understanding or participation in the therapy sessions.
- Presence of uncontrolled medical conditions (e.g., severe epilepsy, cardiac conditions) that would pose a risk during physical activity.
- Previous extensive therapy for fine motor skills in the past 6 months, which might influence the study outcomes.
- Lack of compliance or cooperation from the child or parents/guardians during a preliminary assessment.(Raipure et al., 2023).
All participants will be given the intervention for 45 minutes, 4 days a week, for 3 consecutive weeks.
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 (Participant)
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed medical diagnosis of spastic diplegic cerebral palsy by a healthcare professional.
- •Children aged between 8 to 12 years old.
- •Documented difficulties in fine motor skills, assessed by a standardized motor skills evaluation tool.
- •Ability to understand and follow instructions, with or without assistance, to participate in the therapy sessions.
- •Written informed consent from parents or legal guardians, allowing the child to participate in the study.
排除标准
- •Presence of any other significant medical condition that might interfere
- •Diagnosis of other forms of cerebral palsy (e.g., hemiplegic, quadriplegic).
- •Severe cognitive impairments that would prevent understanding or participation in the therapy sessions.
- •Presence of uncontrolled medical conditions (e.g., severe epilepsy, cardiac conditions) that would pose a risk during physical activity.
- •Previous extensive therapy for fine motor skills in the past 6 months, which might influence the study outcomes.
- •Lack of compliance or cooperation from the child or parents/guardians during a preliminary assessment.
研究组 & 干预措施
Group A NDT
Experimental
5-Minute Warm-Up: Light mobility exercises (e.g., Hand pumps, seated marching)
- Resistance Bands: Strengthen upper limbs (e.g. Bicep curls, shoulder abduction, chest presses.).
- Small Dumbbells: Improve upper body strength (1-2 lbs for shoulder/arm exercises).
- Stress Ball Squeezes: Enhance grip strength and hand function (5-10 reps/session).
- Frequency: 4 days a week, for 3 consecutive weeks
- Intensity: Moderate resistance; emphasize alignment and controlled movement
- Time: 40-minute sessions (30 minutes active exercise, 10 minutes rest/feedback).
干预措施: Group A NDT (Other)
Group B Play-Based Therapy
Experimental
5-Minute Warm-Up: Gentle play (e.g., rolling a ball, stretching with ribbons)
- Building Blocks: Focus on fine motor control, bilateral coordination, and problem-solving.
- Puzzles: Enhance spatial awareness, grip strength, and cognitive engagement.
- Arts and Crafts: Promote hand-eye coordination (e.g., cutting, drawing) and creativity.
- Frequency: 4 days a week, for 3 consecutive weeks
- Intensity: Moderate effort; tasks tailored to the child's skill level (e.g., 5 piece puzzles progressing to 10-piece).
- Time: 45-minute sessions (30 minutes active play, 10 minutes rest/reinforcement).
干预措施: Group B Play-Based Therapy (Other)
结局指标
主要结局
Peabody Developmental Motor Scales (PDMS-2)
时间窗: from enrollment to the end of treatment at 12 weeks
for evaluating fine motor skills.
Modified Ashworth Scale (MAS)
时间窗: at the time of enrollment and at the end of 12 week
To measure muscle spasticity (tone) in the limbs.
次要结局
- CHQ(at the time of enrollment then 8 week and then 12 week)
研究者
研究点 (1)
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