NCT04979689

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 28, 2021

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

7 months

First QC Date

July 19, 2021

Last Update Submit

July 27, 2021

Conditions

Keywords

external rotation, Intensive session, C5-C6

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Goniometer

    12th Weeks, 5th day

Study Arms (2)

Intensive physical therapy

EXPERIMENTAL

Intensive session

Other: Intensive physical therapy

Non intensive physical therapy

OTHER

Non intensive session

Other: Non intensive physical therapy

Interventions

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.

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.

Non intensive physical therapy

Eligibility Criteria

Age9 Months - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children Hospital

Lahore, Punjab Province, Pakistan

Location

Related Publications (10)

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

    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.

    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.

    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.

    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

    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.

    PMID: 19064174BACKGROUND
  • 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).

    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.

    PMID: 26045324BACKGROUND
  • 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.

    PMID: 31284431BACKGROUND
  • CK O. A Case of Erb-Duchenne Palsy in a Man, Aged 24. MOJ Anat Physiol. 2017;3(6):184-6.

    BACKGROUND

MeSH Terms

Conditions

Brachial Plexus Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Mehwish Ikram, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2021

First Posted

July 28, 2021

Study Start

October 30, 2020

Primary Completion

May 30, 2021

Study Completion

June 30, 2021

Last Updated

July 28, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations