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临床试验/NCT07244042
NCT07244042招募中不适用

Effects of Modified Constraint-induced Movement Therapy With and Without Proprioceptive Neuromuscular Facilitation Techniques on Upper Extremity Function in Pediatric Stroke Patients

Riphah International University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年10月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Modified Ashworth Scale (MAS)

研究概览

简要总结

This randomized clinical trial investigates the effects of modified CIMT with and without the addition of PNF techniques on upper extremity function in pediatric stroke patients, aiming to determine whether combining these approaches yields superior motor recovery.This study will be conducted as a randomized clinical trial over an intervention period of six-week. 20 pediatric stroke patients with upper extremity impairments will be randomly assigned to two groups: one receiving modified CIMT alone and the other receiving modified CIMT combined with PNF techniques. Pre- and post-intervention assessments will be conducted using standardized measures, such as Pediatric Motor Activity Log(PMAL) for upper extremity function, Modified Ashworth Scale(MAS) and Manual Ability Classification System(MACS). Muscle tone and physical activity status will also be evaluated. Data will be entered and analyzed in SPSS V-26.0 to compare improvements in motor function between the two groups, with statistical significance assessed to determine the efficacy of each intervention

详细描述

Pediatric stroke often results in impaired upper extremity function, significantly affecting children's ability to perform daily tasks and reducing their overall quality of life. Traditional therapeutic approaches may not provide sufficient recovery, necessitating the exploration of more effective interventions. Constraint-Induced Movement Therapy (CIMT) has been shown to improve motor function in pediatric stroke patients by enhancing the use of the affected limb. However, incorporating Proprioceptive Neuromuscular Facilitation (PNF) techniques may enhance the outcomes further by stimulating neuromuscular pathways to improve strength and coordination. The objective of this study is to compare the effects of modified CIMT with and without the addition of PNF techniques on upper extremity function in pediatric stroke patients, aiming to determine whether combining these approaches yields superior motor recovery.

This study will be conducted as a randomized clinical trial over an intervention period of six-week. 20 pediatric stroke patients with upper extremity impair-ents will be randomly assigned to two groups: one receiving modified CIMT alone and the other receiving modified CIMT combined with PNF techniques. Pre- and post-intervention assessments will be conducted using standardized measures, such as Pediatric Motor Activity Log(PMAL) for upper extremity function, Modified Ashworth Scale(MAS) and Manual Ability Classification System(MACS). Muscle tone and physical activity status will also be evaluated. Data will be entered and analyzed in SPSS V-26.0 to compare improvements in motor function between the two groups, with statistical significance assessed to determine the efficacy of each intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

Participants will get separate treatment protocols and possible efforts will be put to mask the both groups about the treatment

入排标准

年龄范围
5 Years 至 13 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Paeds Patients with confirmed diagnosis of Stroke
  • •Children between age 5 to 13 years
  • •Modified Ashworth Scale spasticity level 1 and
  • •Patients having Manual Ability Classification System Score between 3 to
  • •GMFCS level 1 and 2
  • •Patient having in affected upper extremity at least 20◦ of active wrist extension starting from the full flexion, 10◦ of active extension or abduction in the thumb, and 10◦ of active extension in the metacarpophalangeal and interphalangeal joints of the other fingers

排除标准

  • •Patients with epilepsy or seizure disorder
  • •Patients with history of botulinum toxin injection, cognitive impairment, fracture and any surgical procedure in upper extremity

研究组 & 干预措施

Group A: Intervention Group (Modified CIMT+PNF)

Active Comparator

Modified CIMT: Constraining the unaffected arm with a mitt or splint to encourage use of the affected arm (3-5 times a week).

PNF Techniques: Includes rhythmic initiation, combination of isotonics, and replication exercises to enhance proprioception and motor control in the affected arm (10 reps of each technique for 15-20 minutes with rest interval) Rest Interval for 1-2 minute to prevent fatigue Routine Physiotherapy Exercises: Targeted exercises focusing on strength, range of motion, and coordination.

  • Strengthening: 3 sets of 10-12 reps per targeted muscle group (e.g., biceps, wrist extensors).
  • Range of Motion (ROM): 10-15 repetitions per joint (e.g., shoulder, elbow, wrist).
  • Coordination and Functional Training: Structured tasks such as reaching and grasping toys or objects for 15-20 minutes.

Duration: 6 weeks

干预措施: Modified CIMT (Other)

Group A: Intervention Group (Modified CIMT+PNF)

Active Comparator

Modified CIMT: Constraining the unaffected arm with a mitt or splint to encourage use of the affected arm (3-5 times a week).

PNF Techniques: Includes rhythmic initiation, combination of isotonics, and replication exercises to enhance proprioception and motor control in the affected arm (10 reps of each technique for 15-20 minutes with rest interval) Rest Interval for 1-2 minute to prevent fatigue Routine Physiotherapy Exercises: Targeted exercises focusing on strength, range of motion, and coordination.

  • Strengthening: 3 sets of 10-12 reps per targeted muscle group (e.g., biceps, wrist extensors).
  • Range of Motion (ROM): 10-15 repetitions per joint (e.g., shoulder, elbow, wrist).
  • Coordination and Functional Training: Structured tasks such as reaching and grasping toys or objects for 15-20 minutes.

Duration: 6 weeks

干预措施: Proprioceptive Neuromuscular Facilitation (Other)

Group B: Control Group (Modified CIMT only)

Active Comparator

Warm-Up Exercises:

10-15 minutes of light exercises for the affected arm, focusing on gentle range of motion.

Modified CIMT: Constraining the unaffected arm with a mitt or splint to promote use of the affected arm(3-5 times a week). Routine Physiotherapy Exercises: Targeted exercises focusing on strength, range of motion, and coordination.

  • Strengthening: 3 sets of 10-12 reps per targeted muscle group (e.g., biceps, wrist extensors).
  • Coordination and Functional Training: Structured tasks such as reaching and grasping toys or objects for 15-20 minutes.

Duration: 6 week

干预措施: Modified CIMT (Other)

结局指标

主要结局

Modified Ashworth Scale (MAS)

时间窗: Base line, 3rd Week, 6th week

This scale will be used to assess the degree of spasticity in the affected upper limb.

Pediatric Motor Activity Log (PMAL)

时间窗: Base line, 3rd Week, 6th week

This log will be used to assess the spontaneous use of the affected upper limb in daily activities. Parents/guardians will rate the frequency and quality of use.

Manual Ability Classification System (MACS)

时间窗: Base line, 3rd Week, 6th week

The MACS will classify the participant's ability to handle objects and perform manual tasks in daily activities.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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