CClinicalTrials.gg
CompletedNCT06631664RESUpdated Oct 8, 2024

Electrical Stimulation on Erbs Palsy Infants

An interventional study of Traditional physical therapy and A computerized electrical stimulator (Vectra®2C; Chattanooga, TS, USA) in Erbs Palsy, sponsored by Badr University. Completed at 1 site in Saudi Arabia. Open to participants aged 2 Months to 5 Months. Per ClinicalTrials.gov, last updated 2024-10-08.

Sponsored by Badr University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Dec 2023, 2 years 9 months ago, and no results have been posted to the registry.
  • Registered 1 year 5 months after the study started (first participant enrolled Apr 2023, registered Sep 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
2 Months to 5 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Erbs Palsy

Keywords

  • Brachial plexus birth injury
  • Neuromuscular electrical stimulation
  • Active motion
  • Electroneurography
  • Motor function
03

In context

Lead sponsor

Badr University is the lead sponsor of 60 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Months to 5 Months
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Study group

    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)

  • Other
    Control group

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

    Other: Traditional physical therapy

Interventions

  • OtherTraditional 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.

  • DeviceA 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.

06

What researchers measure

Primary outcomes

  1. 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}

    Time frame: 2 months

  2. 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

    Time frame: 2 months

07

Study locations

1 site
  • Prince Sattam bin Abdul-Aziz University
    Al-Kharj, 11952, Saudi Arabia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06631664
Lead sponsor
Badr University
Collaborators
Prince Sattam Bin Abdulaziz University
Responsible party
Hend Reda Sakr (Lecturer of Physical Therapy, Badr University) — Principal investigator
First posted
Oct 8, 2024
Start date
Apr 23, 2023
Primary completion
Dec 27, 2023
Completion
Mar 24, 2024
Last update
Oct 8, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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