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临床试验/NCT06631664
NCT06631664已完成不适用

Contribution of Reciprocal Electrical Stimulation Across Elbow Muscles in Motor Recovery of Infants With Erbs Palsy: a Randomized Controlled Trial

Badr University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年4月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Percentage of degeneration

研究概览

简要总结

This study examined the effect of reciprocal electrical stimulation (RES) across elbow flexors and extensors on the reaction of degeneration percentage and motor function in Erbs palsy infants.

Forty infants with Erb's palsy aged between 2-5 months were randomly allocated to one of two equal groups: the control group (A) received standard physical therapy, the study group (B) received traditional physical therapy plus a 15-minute RES through elbow flexors and extensors. For three months, interventions were carried out three times each week. The percentage of degeneration and motor function reaction were assessed pre-and post-treatment using electromyography and Toronto active motion scale, respectively.

详细描述

This study examined the effect of reciprocal electrical stimulation (RES) across elbow flexors and extensors on the reaction of degeneration percentage and motor function in Erbs palsy infants.

Forty infants with Erb's palsy aged between 2-5 months were randomly allocated to one of two equal groups: the control group (A) received standard physical therapy, the study group (B) received traditional physical therapy plus a 15-minute RES through elbow flexors and extensors. For three months, interventions were carried out three times each week. The percentage of reaction of degeneration and motor function were assessed pre-and post-treatment using electromyography and the Toronto active motion scale respectively.

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 (Investigator)

盲法说明

The investigator was blinded to the interventions

入排标准

年龄范围
2 Months 至 5 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Infants with OBPI limited to nerve roots C5, C6, with/without involvement of C7, partial lesion as determined by electrophysiological examinations, age between two to five months, and willingness of the infant's family to take part in the study.

排除标准

  • Infants with clavicular or humeral fractures, complete transection of nerve roots, other neurological co-morbidities such cerebral palsy, congenital musculoskeletal deformities, or recommendation against electrical stimulation by the attending neuro-pediatrician.

结局指标

主要结局

Percentage of degeneration

时间窗: 2 months

Surface electrodes were used in a computerized electromyographic device (Neuro screen plus four channel-version, TOENNES 97204 Hochberg, Germany) to calculate the percentage of degeneration of the biceps and triceps brachii muscles. A 1 Hz frequency and 5 ms time basis were used to create a rectangular pulse. The strength of the stimulating current was gradually raised until there was no further rise in the amplitude of the diphasic myogenic compound action potential. A 10% increase in current was given to assure supramaximal stimulation. The level of stimulation ranges from 15 to 40 mA. The Neuro screen plus system's software was used to calculate the peak-to-peak amplitude. The following equation was used to compute the percentages of degeneration: RD= 100{Amplitude of evoked response(in µv) affected side/Amplitude of evoked response(in µv)normal side x 100}

Toronto active motion scale (TAMS)

时间窗: 2 months

The motor recovery was assessed using the Toronto Active Motion Scale (TAMS). For this study, scores for elbow flexion and extension were recorded. It consists of 15 movements of upper limb joints with an eight-point scale measuring the strength of these movements, first by measuring the range of motion at each joint with gravity eliminated, and then measuring the range of motion against gravity. The scoring of the TAMS is defined as follows: Observation Gravity elimination Muscle grade No muscle contraction 0 Contraction, no movement 1 Motion \< range 2 Motion \> range 3 Full range of movement 4 Against gravity Motion \< range 5 Motion \> range 6 Full range of movement 7

次要结局

未报告次要终点

研究者

发起方
Badr University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hend Reda Sakr

Lecturer of Physical Therapy

Badr University

研究点 (2)

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