Electrical Stimulation on Erbs Palsy Infants

NCT06631664 | Completed FDA Device

• 1 other identifier: Hend 6
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Erbs Palsy

Keywords

Brachial plexus birth injury; Neuromuscular electrical stimulation; Active motion; Electroneurography; Motor function

Outcome Measures

Primary Outcomes (2)

• Percentage of degeneration

  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}

  2 months

• Toronto active motion scale (TAMS)

  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

  2 months

Study Arms (2)

Study group

EXPERIMENTAL

Twenty children suffering from Obstetric brachial plexus injury limited to nerve roots C5, C6, with/without involvement of C7

Other: Traditional physical therapy; Device: A computerized electrical stimulator (Vectra®2C; Chattanooga, TS, USA)

Control group

OTHER

Twenty children suffering from Obstetric brachial plexus injury limited to nerve roots C5, C6, with/without involvement of C7

Other: Traditional physical therapy

Interventions

Traditional physical therapy OTHER

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.

Control group; Study group

A computerized electrical stimulator (Vectra®2C; Chattanooga, TS, USA) DEVICE

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.

Study group

Eligibility Criteria

• Age: 2 Months - 5 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Badr University: lead
• Prince Sattam Bin Abdulaziz University: collaborator

Study Sites (1)

Prince Sattam bin Abdul-Aziz University

Al Kharj, 11952, Saudi Arabia

Location

MeSH Terms

Conditions

Brachial Plexus Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator was blinded to the interventions
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical Therapy

Model Details: A prospective single-blind randomized clinical trial

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 8, 2024
• Study Start: April 23, 2023
• Primary Completion: December 27, 2023
• Study Completion: March 24, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)