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Completed

NCT Number: NCT05411731

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

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.

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Key information

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bakhtawar Amin Trust Teaching Hospital

Multan Khurd, Punjab Province, 59300, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

conventional physical therapy treatment

Other

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

Other

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 outcomes

  1. Mallet grading system

    Time frame: 4 weeks

    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 outcomes

  1. goniometer

    Time frame: 4th week

    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.

  2. Upper extremity function index

    Time frame: 4th week

    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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effect of Modified Constraint Induced Movement Therapy on Range of Motion, Function and Disability in Children With Obstetric Brachial Plexus Injury

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 9, 2022
Registry last updated
Mar 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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