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OpenTrials
Completed

NCT Number: NCT05334511

Functional Electrical Stimulation On Functional Rehabilitation In Children With Erb's Palsy

Erb's palsy is a type of brachial plexus injury occurs in infants due to injury of nerves during childbirth. Injury causes weakness or paralysis of different muscles. Different type of approaches are made for the treatment of erb;s palsy such passive range of motion, stretching ,splinting ,electrotherapy etc. In erb's palsy the most affected ranges are shoulder abduction and shoulder external rotation. Quasi experimental study will be done on the patient with erb's palsy intervention applied will be functional electrical stimulation (a low frequency current) applied 5 day a weeks for 2 weeks than on alternate days for the rest of the treatment. Setting for functional electrical stimulation will be Frequency 20 pps with Pulse width of 300 msec. 18 patient will be recruited . "Assumed population standard deviation"4.24" "Confidence level""0.95" "Acceptable error""2". Pre-intervention reading will be taken on modified mallet scale and universal goniometer and post intervention measurement will be taken after 02, 04 ,06 months.

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Key information

Conditions

Erb's Palsy Brachial Plexus Neuropathies Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

15 month–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children Complex Hospital

Faisalābad, Punjab Province, 38000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with Erb's Palsy
  • Children of age 15 months to 3 years

Exclusion criteria

  • hemiplegic cerebral palsy
  • children with upper limb fractures
  • obstetrical brachial plexus injury
  • upper limb contracture

Treatment and study plan

Functional Electrical Stimulation

Other

functional electrical stimulation with Frequency 20 pps with Pulse width of 300 msec.

Primary outcomes

  1. Change in Modified mallet scale Score

    Time frame: Baseline, 2nd, 4th and 6th Months

    Modified Mallet scale evaluation of function and arm appearance. In addition to assessing the classical shoulder functions of the classical Modified Mallet system, supination and the resting position are evaluated. In the resting position, medial rotation at the shoulder is scored on a scale of 1 to 5. 1 is the lowest score and 5 is the highest score

  2. Change in range of motion

    Time frame: Baseline, 2nd, 4th and 6th months

    A goniometer is an instrument that measures the available range of motion at a joint. The art and science of measuring the joint ranges in each plane of the joint are called goniometry.

    To measure the range of motion physical therapists most commonly use a goniometer.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects Of Functional Electrical Stimulation On Functional Rehabilitation In Children With Erb's Palsy

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 19, 2022
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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