Clinical trial NCT04979689: Intensive Therapy of Shoulder External Rotators in Erb's Palsy
Official title: Effects of Physical Rehabilitation With and Without Intensive Exercise Therapy of Shoulder External Rotators in Patients With Erb's Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erbs Palsy
Keywords: external rotation, Intensive session, C5-C6
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 20
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Modified MALLET scale
timeFrame: 12th weeks
Secondary outcomes:
measure: Goniometer
timeFrame: 12th Weeks, 5th day
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Children Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Mehwish Ikram, MS
role: PRINCIPAL_INVESTIGATOR
References:
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