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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05411731
Other study ID # REC/RCR&AHS/22/0701
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 30, 2022
Est. completion date September 1, 2022

Study information

Verified date March 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date September 1, 2022
Est. primary completion date September 1, 2022
Accepts healthy volunteers No
Gender All
Age group 3 Years to 10 Years
Eligibility Inclusion Criteria: - 3 to 10 years - Both genders will be included - Deficiency of shoulder abduction and external rotation - Who can follows command Exclusion Criteria: - uncontrolled seizures - Orthopedic and/or neurological surgery. - A visual impairment interfering with treatment/testing. - Unable to actively engage in assessment process

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Conventional physical therapy treatment
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
Constraint induced movement therapy
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.

Locations

Country Name City State
Pakistan Bakhtawar Amin Trust Teaching Hospital Multan Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 goniometer changes from the baseline ROM of shoulder abduction and external rotation as well as elbow ranges was measured by goniometer was measured by can evaluate both active as well as passive range of motion. 4th week
Secondary Upper extremity function index It is a self-administered questionnaire which measures disability in people with upper extremity orthopaedic conditions. The questionnaire lists 20 activities and the patient gives a score to each based on the difficulty they have completing that activity. It is evaluated on a 5-point scale that refers to the perceived difficulty in performing the mentioned action:
Extreme difficulty or unable to perform activity (0 points);
Quite a bit of difficulty (1 point);
Moderate difficulty (2 points);
A little bit of difficulty (3 points);
No difficulty (4 points).
The overall Upper extremity function index (UEFI) result ranges between 0 and 80, where 0 indicates most severe limitation and 80 suggests least limitation. Changes from baseline function of affected extremity was given by this tool.
4th week
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