Intensive Therapy of Shoulder External Rotators in Erb's Palsy

NCT ID: NCT04979689

Last Updated: 2021-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-30
• Study Completion Date: 2021-06-30

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

Conditions

Erbs Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intensive physical therapy

Intensive session

Group Type: EXPERIMENTAL

Intensive physical therapy

Intervention Type: OTHER

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.

Non intensive physical therapy

Non intensive session

Group Type: OTHER

Non intensive physical therapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 9 Months
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mehwish Ikram, MS

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Children Hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

References

@article{basit2018erb, Palsy} T, author={Basit, Hajira and Ali, Citra Dewi M and Madhani NB, Year={2018}. Erbs Palsy

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 19064174 (View on PubMed)

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).

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 26045324 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31284431 (View on PubMed)

CK O. A Case of Erb-Duchenne Palsy in a Man, Aged 24. MOJ Anat Physiol. 2017;3(6):184-6.

Reference Type: BACKGROUND

Other Identifiers

REC/Lhr/21/0204 Qurat

Identifier Type: -

Identifier Source: org_study_id