Effects of Modified Constraint-induced Movement Therapy With and Without Electrical Stimulation in Erb's Palsy

March 4, 2024 updated by: Riphah International University

Effects of Modified Constraint-induced Movement Therapy With and Without Electrical Stimulation on Range of Motion, Muscle Strength, and Motor Function in ERB's Palsy

ERB's palsy is an injury of upper section of the brachial plexus (C5-6) leading to an internally rotated and adducted shoulder and a pronated forearm. Modified constraint-induced movement therapy improves the functionality of the affected limb, while electrical stimulation helps in the improvement of active range of motion and muscle strength in ERB's palsy patients. This study aims to investigate the effects of modified constraint-induced movement therapy with and without electrical stimulation on range of motion, muscle strength, and motor functions in patients with ERB's Palsy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This randomized clinical trial will be conducted at the Children's Hospital. The sample size will consist of 34 participants. Participants who meet the inclusion criteria will be randomly allocated into two groups using an online randomization tool; Group A will receive modified constraint-induced movement therapy with electrical stimulation and Group B will receive modified constraint-induced movement therapy only. Both groups will receive routine physical therapy as a part of treatment. All participants will receive a 60-minute session, 6 times a week for 16 weeks.

Universal Goniometer will be used to assess range of motion, the Medical Research Council Scale for muscle strength, and the Active Movement Scale for motor function at baseline, 4th, 8th, 12th, and 16th weeks after treatment discontinuation. The data will be analyzed using SPSS version 26 for Windows software.

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54660
        • Riphah International University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Children with a confirmed diagnosis of ERB's palsy.
  2. Muscle power of the affected limb should be between 1 to 4.
  3. Active finger range of motion,10-degree wrist extension, and thumb abduction.

Exclusion Criteria:

  1. Children having contracture and stiffness of affected limb.
  2. Muscle power of affected limb 0 or 5.
  3. Children with cerebral palsy, visual, hearing, and cognitive problems, or any neuromuscular, and skeletal disorders.
  4. Previous history of neurological and orthopedic surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: (Modified constraint-induced movement therapy + electrical stimulation)

Group A will include 17 participants. The participants in this group will receive a 60-minute session daily. Each participant will perform 96 sessions (6 times per week over 16 weeks) for 60 minutes daily.

  1. Electrical stimulation for 20 minutes
  2. Routine physical therapy for 10 minutes
  3. Modified constraint-induced movement therapy for 30 minutes.
Other: Modified constraint-induced movement therapy

The unaffected arm will be restricted by using an upper extremity sling that will strap to the child's trunk with a distal end fastened to prevent the movement of the unaffected limb.

The modified constraint-induced movement therapy will include these exercises.

  1. Playing with ball.
  2. Playing with modeling clay.
  3. Playing with LEGOS (building towers or different shapes from the toy bricks).
  4. Tearing a paper towel from a roll.
  5. Holding and eating biscuits.
  6. Eating with a spoon.
  7. Drinking from a glass.
  8. Combing hair.
  9. Brushing teeth.
  10. Making bubbles using a bubble blower.
  11. Pulling a toy.
  12. Placing a hat or piece of cloth on the head.
  13. Applying lotion to the trained caregiver.
Other: Electrical stimulation
The participants in this group will first receive a 20-minute session of electrical stimulation (on time of 10 s, off time of 30 s, pulse rate of 35 Hz, the pulse width of 300 µs).
Experimental: Group B: (Modified constraint-induced movement therapy)

17 participants will be included in this group. The participants in this group will also receive a 60-minute session daily (6 times per week over 19 weeks).

  1. Routine physical therapy for 10 minutes.
  2. Modified constraint-induced movement therapy for 50 minutes.
Other: Modified constraint-induced movement therapy

The unaffected arm will be restricted by using an upper extremity sling that will strap to the child's trunk with a distal end fastened to prevent the movement of the unaffected limb.

The modified constraint-induced movement therapy will include these exercises.

  1. Playing with ball.
  2. Playing with modeling clay.
  3. Playing with LEGOS (building towers or different shapes from the toy bricks).
  4. Tearing a paper towel from a roll.
  5. Holding and eating biscuits.
  6. Eating with a spoon.
  7. Drinking from a glass.
  8. Combing hair.
  9. Brushing teeth.
  10. Making bubbles using a bubble blower.
  11. Pulling a toy.
  12. Placing a hat or piece of cloth on the head.
  13. Applying lotion to the trained caregiver.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standard universal goniometer
Time Frame: 16 weeks
It is a device used to measure the range of motion of joints. It consists of four parts: body, fulcrum, stationary, and the moving arm.
16 weeks
Medical Research Council (MRC) Scale
Time Frame: 16 weeks
It is scale used for testing muscle strength, ranging from Grade 5 (movement through full ROM with maximum resistance against gravity), Grade 4 (movement through full ROM with moderate resistance against gravity), Grade 3 (movement through full ROM without resistance against gravity), Grade 2 (movement through full ROM with gravity eliminated), Grade 1 (flicker of movement) to Grade 0 (no apparent contraction).
16 weeks
Active Movement Scale
Time Frame: 16 weeks
It is used to quantify movement and assess upper limb motor function. It assesses 15 joint motions (range of motion and muscle strength) from the shoulder to the hand on an 8-point scale (0 ¼ no muscle tone or contraction when gravity is removed, 7 ¼ full range against gravity).
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Study Chair: Muhammad Kashif, PhD-PT, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2024

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 15, 2024

Study Registration Dates

First Submitted

March 4, 2024

First Submitted That Met QC Criteria

March 4, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR & AHS/23/0292

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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