NCT06198218

Brief Summary

Erb's Palsy is a physical impairment resulting from an injury to the upper trunk of the brachial plexus and is associated with paralysis of the upper limb. When the neck is stretched up and move away from the wounded shoulder while the shoulder is pressed down, damage to the top nerves that make up the brachial plexus is more likely to damage .These injuries occur due to traumatic activities(vehicle accidents),difficult births(breeched presentation ,prolonged labor and high birth weight).This study proposes to analyze the effects of activity based scapular mobilization on upper limb functions in children who have been diagnosed with Erb's Palsy. This will be a randomized control trial study. Data will be collected from 30 patients who will be randomly assigned to two groups of equal numbers experimental and control group each with 15. The participants of the experimental group will be treated with scapular mobilization ,activity based scapular mobilization(codman pendulum exercises,scapular pushups, band wall apart,wall ball circles and advance study wall pushups) along with conventional physical therapy program. Participants of control group is treated with activity based scapular mobilization and conventional physical therapy program. Patient evaluation will be made at the beginning and end of the treatment. Data will be analyzed through SPSS 25.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 26, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

December 26, 2023

Last Update Submit

June 11, 2024

Conditions

Keywords

Erbs palsyscapular mobilizationmallet scorecodman exercises

Outcome Measures

Primary Outcomes (2)

  • range of motion

    A goniometer is a tool used to measure angles. It is an important tool for those studying anatomy, helping to measure the range of motion in joints. Goniometers are also used in physical therapy, engineering, and other fields.

    8 weeks

  • functional capacity

    Box-and-block tests are a type of physical evaluation used to measure an individuals lateral rotation. Angles are measured from video stills for abduction, hand to mouth and apparent supination and estimated for lateral rotation.

    8 weeks

Study Arms (2)

Scapular mobilization

EXPERIMENTAL

This Experimental group will be treated with manual scapular mobilization in upward rotation and downward rotation, adduction and abduction of scapula. Sets of 10 repetitions were applied with a rest interval of 30 seconds between set for 20 minutes, activity based scapular mobilization(Codman pendulum exercises, scapular pushups, band wall apart ,wall ball circles and advance study wall pushups) along with conventional physical therapy program(heating,EMS,stretching for tight muscles , strengthening exercises and graduated active exercises) for 25 minutes

Other: Scapular mobilization

Conventional physical therapy program

ACTIVE COMPARATOR

This group will receive conventional physical therapy program including ( heating to improve circulation and release muscle tension ,EMS ,stretching for stiff muscle, weight bearing, strengthening exercises and graduated active exercises)for 20 minutes along with activity based scapular mobilization( Codman pendulum exercises, ban wall apart, wall ball circles, scapular pushups and advance study wall pushups)for 20 minutes with 5 minute resting interval.

Other: Conventional physical therapy program

Interventions

Group A: will be treated with manual scapular mobilization in upward rotation and downward rotation, adduction and abduction of scapula.Sets of 10 repetitions were applied with a rest interval of 30 seconds between set for 20 minutes, activity based scapular mobilization(Codman pendulum exercises, scapular pushups, band wall apart ,wall ball circles and advance study wall pushups) along with conventional physical therapy program(heating,EMS,stretching for tight muscles , strengthening exercises and graduated active exercises) for 25 min

Also known as: Standard
Scapular mobilization

Group B:will receive conventional physical therapy program including (heating to improve circulation and release muscle tension,EMS,stretching for stiff muscle,weight bearing, strengthening exercises \& graduated active exercises)for 20 min along with activity based scapular mobilization (Codman pendulum exercises,band wall apart,wall ball circles, scapular pushups and advance study wall pushups)for 20 min with 5 min resting interval.

Conventional physical therapy program

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age: between 6-9 years
  • Diagnosed as obs. Erb's palsy
  • Able to perform exercise
  • Unilateral involvement of shoulder joint
  • Unilateral active and passive movement of shoulder joint
  • Both male and female involved
  • Willing to participate

You may not qualify if:

  • No history of surgery (arthroscopy, fixations)
  • Any skin condition ( Allergies, infection)
  • Local corticosteroids injections into the effected shoulder over last 3 months
  • No present Fracture/ contractures
  • Neurological disorders with muscle weakness in shoulder joint .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

  • Ho ES, Curtis CG, Clarke HM. The brachial plexus outcome measure: development, internal consistency, and construct validity. J Hand Ther. 2012 Oct-Dec;25(4):406-16; quiz 417. doi: 10.1016/j.jht.2012.05.002. Epub 2012 Jul 20.

    PMID: 22818900BACKGROUND

MeSH Terms

Conditions

Brachial Plexus Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Amina Bibi, MS*

    Riphah International Univeristy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will get separate treatment protocol as and possible efforts will be put to mask the both groups about their treatment
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2023

First Posted

January 10, 2024

Study Start

December 1, 2023

Primary Completion

January 31, 2024

Study Completion

February 15, 2024

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations