Intensive Therapy of Shoulder External Rotators in Erb's Palsy

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

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.

Study Overview

• Status: Completed
• Conditions: Erbs Palsy
• Intervention / Treatment: Other: Intensive physical therapy; Other: Non intensive physical therapy

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

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan
      • Children Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 4 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intensive physical therapy; Intensive session	Other: Intensive physical therapy; Intensive physical therapy treatment protocol was given for 3 months 3 times a week including 1.5- 2-hour session. Pre and post treatment assessments were taken. It included stretching for 20 min, Proprioception on ball for 20 minutes, quadruped for 10 min, vibration therapy for 20 min, tapping twice a month for 5 days, sensory therapy with beans for 20 min, supine lying with hand below head for 10-15 min, texturing for 15 min and activity of making tower with cups and hitting in outward direction for 15-20 min.
Other: Non intensive physical therapy; Non intensive session	Other: Non intensive physical therapy; Non intensive therapy included 45 min session 3 times a week for 3 months. Pre and post treatment assessments were taken. The protocol included stretching for 20 min, cross friction massage for 15 min, Ball catch and throw for 15 min. progression was made from light to heavy weight ball.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified MALLET scale	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.	12th weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Goniometer	A goniometer is an instrument which measures the available range of motion at a joint. (Also mention all information which ROM u want to check) One BY one IN 4 and 5th number	12th Weeks, 5th day

Collaborators and Investigators

• Sponsor: Riphah International University

Publications and helpful links

General Publications

• @article{basit2018erb, Palsy} T, author={Basit, Hajira and Ali, Citra Dewi M and Madhani NB, Year={2018}. Erbs Palsy
• Rahat S, Ahmad S, Bushra S. Role of physical therapy in improving the functional outcome of infants with Erb's palsy due to neurapraxia and Axonotmesis. Pakistan J Med Heal Sci. 2019;13(3):815-8.
• Afzal F, Afzal A. Effects of Conventional Combination Physical Therapy Treatment To Improve the Gross Motor and Functional Movements in Children With Erb'S Palsy. Int J Ther Rehabil Res. 2017;6(2):70.
• Sherief AAA. Electrical Stimulation Versus Arm Splint In Improving Fine More Skills In Erb's Palsy Children. Bull Fac Ph Th Cairo Univ. 2011;16(1):91-6.
• Said R, Ahmed S. KINESIO ARM TAPING AS PROPHYLAXIS AGAINST THE DEVELOPMENT OF ERB ' S ENGRAM Thesis Submitted in Partial Fulfillment of the Requirements for a Master Children and Its Surgery. 2004
• Malessy MJ, Pondaag W. Obstetric brachial plexus injuries. Neurosurg Clin N Am. 2009 Jan;20(1):1-14, v. doi: 10.1016/j.nec.2008.07.024.
• Mazhar N, Hashmi M, Bashir S, Khan B, Khan S, Ahmad L. Physiotherapy & Physical Rehabilitation Prevalence of Erb ' s Palsy due to Shoulder Dystocia in Multan. 2019;4(3).
• Kc K, Shakya S, Zhang H. Gestational diabetes mellitus and macrosomia: a literature review. Ann Nutr Metab. 2015;66 Suppl 2:14-20. doi: 10.1159/000371628. Epub 2015 Jun 2.
• Frade F, Gomez-Salgado J, Jacobsohn L, Florindo-Silva F. Rehabilitation of Neonatal Brachial Plexus Palsy: Integrative Literature Review. J Clin Med. 2019 Jul 5;8(7):980. doi: 10.3390/jcm8070980.
• CK O. A Case of Erb-Duchenne Palsy in a Man, Aged 24. MOJ Anat Physiol. 2017;3(6):184-6.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2020
• Primary Completion (Actual): May 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: July 19, 2021
• First Submitted That Met QC Criteria: July 27, 2021
• First Posted (Actual): July 28, 2021

Study Record Updates

• Last Update Posted (Actual): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 27, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: external rotation, Intensive session, C5-C6
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Brachial Plexus Neuropathies
• Other Study ID Numbers: REC/Lhr/21/0204 Qurat

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No