NCT06631664

Electrical Stimulation on Erbs Palsy Infants

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Badr University · Academic / Other
• Sex: All
• Age: 2 Months – 5 Months
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Erbs Palsy

Interventions

Type	Name	Description
OTHER	Traditional physical therapy	Participants received a traditional physical therapy program three times a week, for three successive months. Each session lasted for approximately 30 minutes and composed of the following: 1) Massage (spiral effleurage, longitudinal and transverse thumb effleurage for 5 minutes or until hyperemia), 2) Facilitation of muscle contraction through a variety of tactile and proprioceptive stimulation techniques - this was applied for the shoulder flexors, abductors, and external rotators, elbow flexors, and wrist/finger extensors. In patients whose lesion extend to involve C7, The facilitation techniques were also applied to elbow extensors. 3) Weight-bearing exercise, considering the developmental milestone (prone forearm support, prone full hand support). 4) Range of motion exercises - all joints of the affected side were moved through the full range of motion. 5) Sucking exercise.
DEVICE	A computerized electrical stimulator (Vectra®2C; Chattanooga, TS, USA)	The patient was positioned in supine lying position with the affected arm beside the body and elbow extended, the skin over the anterior and posterior comportment of the upper arm was cleaned using medical cotton sacked in alcohol before the application. The first two stimulating electrodes for the biceps muscle were placed at the superior and inferior 1/3 of anterior surface of the upper arm with a distance in between the two electrodes at least the size of one of them, while the other two electrodes for the triceps muscle were placed at the superior and inferior 1/3 of the posterior surface of the upper arm. One millisecond pulse duration and a frequency of 50Hz with a rectangular shaped pulse were utilized and stimulation was applied for 15 minutes. At first a low-intensity current is applied and gradually increased till a gentle contraction of the muscles appears and allow time for the child to become accustomed to the current and maintained sufficient and observable contraction.

Timeline

• Start date: 2023-04-23
• Primary completion: 2023-12-27
• Completion: 2024-03-24
• First posted: 2024-10-08
• Last updated: 2024-10-08

Locations

1 site across 1 country: Saudi Arabia

Regulatory

• FDA-regulated device study