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CompletedNCT05334511Updated Feb 21, 2023

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

An interventional study of Functional Electrical Stimulation in Erb's Palsy, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to participants aged 15 Months to 3 Years. Per ClinicalTrials.gov, last updated 2023-02-21.

Sponsored by Riphah International University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Nov 2021, registered Apr 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
15 Months to 3 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Erb's Palsy
03

In context

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

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

04

Who can participate

Ages eligible
15 Months to 3 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • hemiplegic cerebral palsy
  • children with upper limb fractures
  • obstetrical brachial plexus injury
  • upper limb contracture
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Functional Electrical Stimulation

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

    Other: Functional Electrical Stimulation

Interventions

  • OtherFunctional Electrical Stimulation

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

06

What researchers measure

Primary outcomes

  1. Change in Modified mallet scale Score

    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

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

  2. Change in range of motion

    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.

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

07

Study locations

1 site
  • Children Complex Hospital
    Faisalābad, Punjab 38000, Pakistan
08

References and documents

Publications

  • Okafor UA, Akinbo SR, Sokunbi OG, Okanlawon AO, Noronha CC. Comparison of electrical stimulation and conventional physiotherapy in functional rehabilitation in Erb's palsy. Nig Q J Hosp Med. 2008 Oct-Dec;18(4):202-5. doi: 10.4314/nqjhm.v18i4.45029. PubMed 19391320 ↗
  • Nath RK, Somasundaram C. Significant improvement in nerve conduction, arm length, and upper extremity function after intraoperative electrical stimulation, neurolysis, and biceps tendon lengthening in obstetric brachial plexus patients. J Orthop Surg Res. 2015 Apr 19;10:51. doi: 10.1186/s13018-015-0191-y. PubMed 25895832 ↗
  • Huang X, Jiang Z, Sun H, Xie B, Lu F, Huang W, Wang T, Xiong H. The effect of a high-quality nursing model employing low-frequency pulse electrical stimulation combined with early systemic functional exercises on the function of the affected limb in brachial plexus injury patients. Am J Transl Res. 2021 May 15;13(5):4939-4948. eCollection 2021. PubMed 34150078 ↗
  • Elnaggar RK. Shoulder Function and Bone Mineralization in Children with Obstetric Brachial Plexus Injury After Neuromuscular Electrical Stimulation During Weight-Bearing Exercises. Am J Phys Med Rehabil. 2016 Apr;95(4):239-47. doi: 10.1097/PHM.0000000000000449. PubMed 26829088 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05334511
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Apr 19, 2022
Start date
Nov 30, 2021
Primary completion
Jun 30, 2022
Completion
Jul 31, 2022
Last update
Feb 21, 2023

Study contacts

Fareeha Kausar, PP-DPT
principal investigator · Riphah International University

Oversight

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

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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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