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临床试验/NCT05723042
NCT05723042已完成不适用

Effects of Neuromuscular Electrical Stimulation With and Without Constraint Induced Movement Therapy on Upper Limb Function in Children With Erb's Palsy

Riphah International University1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2023年1月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
Change in Mallet scale Scores

研究概览

简要总结

Erb's Duchenne paralysis constitutes the single commonest form of brachial plexus injury, brachial plexus injury (BPI) is unfortunately a rather common injury in newborn children. Incidence varies between 0.15 and 3 per 1000 live births in various series and countries. The constraint-induced movement therapy (CIMT) has been used to promote functional gains in individuals with neurological dysfunctions .The constraint-induced movement therapy consists of constraining movement of the non-affected upper extremity and providing intensive training to the involved upper extremity. Neuromuscular electrical stimulation (NMES) has been used for muscle strengthening, maintenance of muscle mass and strength during prolonged periods of immobilisation, selective muscle retraining, and the control of oedema.The aim of this study is to compare the effects of Neuromuscular Electrical Stimulation with and without Constraint Induced Movement Therapy on Upper limb Function in Children with Erb's Palsy.

It is a Randomized Controlled Trial.The sample size calculated by using OpenEpi or GPower. Data will be collected from Jinnah Hospital,Children Hospital,Lahore medical city hospital,Farooq hospital,Rising sun institute and PSRD. The patients will be selected through non-probability convenience sampling,will be divided into two groups. The Group A will receive habituation exercises for six weeks, three times per week for thirty minutes, along with application of neuromuscular electrical stimulation for a period of 6 weeks four times a week and perform Constrained induced movement therapy techniques, each for 8 weeks.The interventions are consisted of 3weeks of casting the unaffected limb followed by 5 weeks of transference activities.. The Group B will be given neuromuscular electrical stimulation for a period of 6 weeks four times a week.Range of motion ,Flexibility exercises will be given as baseline treatment to both groups. The arm function was evaluated by the Mallet score system, while active abduction and external rotation range of motion were measured by a standard universal goniometer. Data will be analyzed by SPSS 25.

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
Double (Participant, Investigator)

入排标准

年龄范围
2 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Aged between 2.5 to 8 years years
  • Clinically diagnosed with erb's palsy/brachial plexus palsy
  • Ability to cooperate with assessments and therapy
  • Full passive ROMs in all motions at the shoulder, elbow, and wrist joints

排除标准

  • Cognitive impairment
  • Contracture in the affected upper extremity
  • Injured unaffected arm
  • Visual problems likely to interfere with treatment/testing
  • Previous orthopedic or neurological surgery
  • Previous application of CIMT

结局指标

主要结局

Change in Mallet scale Scores

时间窗: Baseline, 8th week and 16th week

The Mallet grading remains the most commonly used system in several obstetric brachial plexus centers. One feature of the Mallet score is that each grade is translated into certain degrees of deficiencies in both shoulder abduction and external rotation.

Change in Box and block test scores

时间窗: Baseline, 8th week and 16th week

the BBT has been commonly used in the pediatric field. It is particularly suitable for children for several reasons. First, the evaluation method of the BBT examines essential components of manual dexterity for developing children, such as grasping, holdi

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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