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Clinical Trials/NCT04979689
NCT04979689
Completed
Not Applicable

Effects of Physical Rehabilitation With and Without Intensive Exercise Therapy of Shoulder External Rotators in Patients With Erb's Palsy

Riphah International University1 site in 1 country20 target enrollmentOctober 30, 2020
ConditionsErbs Palsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Erbs Palsy
Sponsor
Riphah International University
Enrollment
20
Locations
1
Primary Endpoint
Modified MALLET scale
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Erb's palsy is a common neurological injury occurs at the time of birth. It causes injury to the upper trunk nerve root c5-c6, i.e., supply is around shoulder and muscles of forearm and these nerves network from the spine and pass through the cervicoaxillary canal in the neck and the ribs and emerge into the axilla. Restoring external rotation in erb's palsy is quite difficult and mostly surgery is recommended but if physiotherapy sessions are given with extended time up to 2 hours and latest techniques are applied to strengthen external rotators then range of external rotation can be improved.

Detailed Description

Erb's palsy is form of brachial plexus palsy which involves injury to cervical nerve roots c5 c6 causing loss of movements and deformities i.e., internally rotated shoulder, hanging arm and waiter's tip hand deformity. Most common risk factors are shoulder dystocia, maternal obesity, breech presentation and high birth weight of child. Its incidence is 0.42 per 1000 live births in which 25% experience permanent impairment and injury. Both Conservative and non-conservative treatment protocols are applied in erb's palsy but key interventions are positioning in early infancy, passive range of motions and gentle stretching. Another latest treatment approach is intensive physical therapy in which single session duration is extended to three to four hours with combination of treatments. This study will be randomized control trial, used to check effectiveness of intensive physical therapy to restore shoulder external rotation in erb's palsy. Subjects with erb's palsy meeting the predetermined inclusion and exclusion criteria will be divided into two groups by using lottery method. Pre assessment will be done by using AROM on goniometer as objective measurement. Subject in one group will be treated with intensive physical therapy and the other with conventional treatment. Each subject will receive 5 Treatment sessions per week for 6 months. Recorded values will be analyzed by using SPSS version 25

Registry
clinicaltrials.gov
Start Date
October 30, 2020
End Date
June 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Children (male and female)
  • Ages ranged from 9 months to 12 months
  • Unilateral involvement of c5, c6 and c7
  • patients did not undergo surgery of the nerves or plexus

Exclusion Criteria

  • Musculoskeletal or neuro-muscular abnormalities other than Erb's palsy
  • Contractures or fixed limitations in the affected upper extremity
  • Hypersensitivity to latex and adhesive tapes

Outcomes

Primary Outcomes

Modified MALLET scale

Time Frame: 12th weeks

A scale of 1 to 5 is used to assess shoulder abduction, global external rotation, hand to neck, hand to back and hand to mouth position. An aggregate score is calculated by summing the 5 individual scores with a maximum score of 5.

Secondary Outcomes

  • Goniometer(12th Weeks, 5th day)

Study Sites (1)

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