NCT05411731

Brief Summary

The aim of this study was to increase and improve the use of affected extremity in obstetric brachial plexus palsy children while restricting the use of less affected arm and the purpose was to improve the function, Range of motion and disability in affected arm of children with brachial plexus injury.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

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

April 30, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 6, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 9, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

March 17, 2023

Status Verified

March 1, 2023

Enrollment Period

4 months

First QC Date

June 6, 2022

Last Update Submit

March 15, 2023

Conditions

Keywords

birth injuries therapyarm functionconstraint induced movement therapybrachial plexus neuropathies

Outcome Measures

Primary Outcomes (1)

  • Mallet grading system

    The Mallet grading system is a commonly used functional scoring system to assess shoulder abduction/external rotation deficits in children with obstetric brachial plexus palsy. One feature of the Mallet score is that each grade is translated in to certain degree of deficiencies in both shoulder abduction and external rotation. A scale of 1 to 5 is used to evaluate shoulder abduction, global external rotation, and hand to neck, hand to back, and hand to mouth positions.

    4 weeks

Secondary Outcomes (2)

  • goniometer

    4th week

  • Upper extremity function index

    4th week

Study Arms (2)

Conventional physical therapy treatment

ACTIVE COMPARATOR

Patients in this group will receive conventional physical therapy i.e. stretching, strengthening exercises, Aeroplan positioning

Other: Conventional physical therapy treatment

Constraint induced movement therapy

EXPERIMENTAL

patients of this group will receive the same treatment along with constraint induced movement therapy

Other: Constraint induced movement therapy

Interventions

The control group (group A) will receive the exercise program which focused on improving the arm function as well as shoulder abduction and external rotation for 10 week. stretching Aeroplan positioning

Conventional physical therapy treatment

The study group (group B) who will receive Modified constraint induced movement therapy for 3 hrs. a day 12 hrs. a week in addition to the same exercise program given to the control group for 10 weeks.

Constraint induced movement therapy

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • to 10 years
  • Both genders will be included
  • Deficiency of shoulder abduction and external rotation
  • Who can follows command

You may not qualify if:

  • uncontrolled seizures
  • Orthopedic and/or neurological surgery.
  • A visual impairment interfering with treatment/testing.
  • Unable to actively engage in assessment process

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakhtawar Amin Trust Teaching Hospital

Multan Khurd, Punjab Province, 59300, Pakistan

Location

Related Publications (11)

  • Pejkova S, Filipce V, Peev I, Nikolovska B, Jovanoski T, Georgieva G, Srbov B. Brachial Plexus Injuries - Review of the Anatomy and the Treatment Options. Pril (Makedon Akad Nauk Umet Odd Med Nauki). 2021 Apr 23;42(1):91-103. doi: 10.2478/prilozi-2021-0008.

    PMID: 33894122BACKGROUND
  • Souza L, Lustosa L, Silva AEL, Martins JV, Pozzo T, Vargas CD. Kinematic Changes in the Uninjured Limb After a Traumatic Brachial Plexus Injury. Front Hum Neurosci. 2021 Dec 9;15:777776. doi: 10.3389/fnhum.2021.777776. eCollection 2021.

    PMID: 34955793BACKGROUND
  • Adler JB, Patterson RL Jr. Erb's palsy. Long-term results of treatment in eighty-eight cases. J Bone Joint Surg Am. 1967 Sep;49(6):1052-64. No abstract available.

    PMID: 6038856BACKGROUND
  • Sparrow J, Zhu L, Gajjar A, Mandrell BN, Ness KK. Constraint-Induced Movement Therapy for Children With Brain Tumors. Pediatr Phys Ther. 2017 Jan;29(1):55-61. doi: 10.1097/PEP.0000000000000331.

    PMID: 27984470BACKGROUND
  • Eren B, Karadag Saygi E, Tokgoz D, Akdeniz Leblebicier M. Modified constraint-induced movement therapy during hospitalization in children with perinatal brachial plexus palsy: A randomized controlled trial. J Hand Ther. 2020 Jul-Sep;33(3):418-425. doi: 10.1016/j.jht.2019.12.008. Epub 2020 Mar 7.

    PMID: 32151503BACKGROUND
  • Berggren J, Baker LL. Therapeutic application of electrical stimulation and constraint induced movement therapy in perinatal brachial plexus injury: A case report. J Hand Ther. 2015 Apr-Jun;28(2):217-20; quiz 221. doi: 10.1016/j.jht.2014.12.006. Epub 2014 Dec 17.

    PMID: 25841560BACKGROUND
  • Wang Q, Zhao JL, Zhu QX, Li J, Meng PP. Comparison of conventional therapy, intensive therapy and modified constraint-induced movement therapy to improve upper extremity function after stroke. J Rehabil Med. 2011 Jun;43(7):619-25. doi: 10.2340/16501977-0819.

    PMID: 21603848BACKGROUND
  • El-Shamy S, Alsharif R. Effect of virtual reality versus conventional physiotherapy on upper extremity function in children with obstetric brachial plexus injury. J Musculoskelet Neuronal Interact. 2017 Dec 1;17(4):319-326.

    PMID: 29199193BACKGROUND
  • Zielinski IM, van Delft R, Voorman JM, Geurts ACH, Steenbergen B, Aarts PBM. The effects of modified constraint-induced movement therapy combined with intensive bimanual training in children with brachial plexus birth injury: a retrospective data base study. Disabil Rehabil. 2021 Aug;43(16):2275-2284. doi: 10.1080/09638288.2019.1697381. Epub 2019 Dec 8.

    PMID: 31814455BACKGROUND
  • Ramey SL, DeLuca SC, Stevenson RD, Conaway M, Darragh AR, Lo W; CHAMP. Constraint-Induced Movement Therapy for Cerebral Palsy: A Randomized Trial. Pediatrics. 2021 Nov;148(5):e2020033878. doi: 10.1542/peds.2020-033878. Epub 2021 Oct 14.

    PMID: 34649982BACKGROUND
  • Werner JM, Berggren J, Loiselle J, Lee GK. Constraint-induced movement therapy for children with neonatal brachial plexus palsy: a randomized crossover trial. Dev Med Child Neurol. 2021 May;63(5):545-551. doi: 10.1111/dmcn.14741. Epub 2020 Nov 21.

    PMID: 33219706BACKGROUND

MeSH Terms

Conditions

Wounds and InjuriesBrachial Plexus Neuropathies

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Hafiza Mehjabeen, ppdpt

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2022

First Posted

June 9, 2022

Study Start

April 30, 2022

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

March 17, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations