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Modified Constraint Induced Movement Therapy in Children With Obstetric Brachial Plexus Injury

Primary Purpose

Obstetric; Injury

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Conventional physical therapy treatment
Constraint induced movement therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstetric; Injury focused on measuring birth injuries therapy, arm function, constraint induced movement therapy, brachial plexus neuropathies

Eligibility Criteria

3 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bakhtawar Amin Trust Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional physical therapy treatment

Constraint induced movement therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
June 6, 2022
Last Updated
March 15, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05411731
Brief Title
Modified Constraint Induced Movement Therapy in Children With Obstetric Brachial Plexus Injury
Official Title
Effect of Modified Constraint Induced Movement Therapy on Range of Motion, Function and Disability in Children With Obstetric Brachial Plexus Injury
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 30, 2022 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstetric; Injury
Keywords
birth injuries therapy, arm function, constraint induced movement therapy, brachial plexus neuropathies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional physical therapy treatment
Arm Type
Active Comparator
Arm Description
Patients in this group will receive conventional physical therapy i.e. stretching, strengthening exercises, Aeroplan positioning
Arm Title
Constraint induced movement therapy
Arm Type
Experimental
Arm Description
patients of this group will receive the same treatment along with constraint induced movement therapy
Intervention Type
Other
Intervention Name(s)
Conventional physical therapy treatment
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Constraint induced movement therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mallet grading system
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
goniometer
Description
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.
Time Frame
4th week
Title
Upper extremity function index
Description
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.
Time Frame
4th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hafiza Mehjabeen, ppdpt
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bakhtawar Amin Trust Teaching Hospital
City
Multān
State/Province
Punjab
ZIP/Postal Code
59300
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33894122
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.
Results Reference
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PubMed Identifier
34955793
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.
Results Reference
background
PubMed Identifier
6038856
Citation
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.
Results Reference
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PubMed Identifier
27984470
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.
Results Reference
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PubMed Identifier
32151503
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.
Results Reference
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PubMed Identifier
25841560
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.
Results Reference
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PubMed Identifier
21603848
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.
Results Reference
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PubMed Identifier
29199193
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.
Results Reference
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PubMed Identifier
31814455
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.
Results Reference
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PubMed Identifier
34649982
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.
Results Reference
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PubMed Identifier
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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.
Results Reference
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Modified Constraint Induced Movement Therapy in Children With Obstetric Brachial Plexus Injury

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