NCT05334511

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 19, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

7 months

First QC Date

April 2, 2022

Last Update Submit

February 20, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    Baseline, 2nd, 4th and 6th Months

  • 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.

    Baseline, 2nd, 4th and 6th months

Study Arms (1)

Functional Electrical Stimulation

EXPERIMENTAL

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

Other: Functional Electrical Stimulation

Interventions

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

Functional Electrical Stimulation

Eligibility Criteria

Age15 Months - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children Complex Hospital

Faisalābad, Punjab Province, 38000, Pakistan

Location

Related Publications (4)

  • 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.

    PMID: 19391320BACKGROUND
  • 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.

    PMID: 25895832BACKGROUND
  • 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.

    PMID: 34150078BACKGROUND
  • 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.

    PMID: 26829088BACKGROUND

MeSH Terms

Conditions

Brachial Plexus Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Fareeha Kausar, PP-DPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2022

First Posted

April 19, 2022

Study Start

November 30, 2021

Primary Completion

June 30, 2022

Study Completion

July 31, 2022

Last Updated

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations