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NCT Number: NCT06303427

Effects of Modified Constraint-induced Movement Therapy With and Without Electrical Stimulation 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.

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Key information

Conditions

Erb's Palsy Brachial Plexus Neuropathies Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah International University

Lahore, Punjab Province, 54660, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Modified Constraint-Induced Movement Therapy

Other

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.

  • Playing with ball.
  • Playing with modeling clay.
  • Playing with LEGOS (building towers or different shapes from the toy bricks).
  • Tearing a paper towel from a roll.
  • Holding and eating biscuits.
  • Eating with a spoon.
  • Drinking from a glass.
  • Combing hair.
  • Brushing teeth.
  • Making bubbles using a bubble blower.
  • Pulling a toy.
  • Placing a hat or piece of cloth on the head.
  • Applying lotion to the trained caregiver.

Electrical Stimulation

Other

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).

Primary outcomes

  1. 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.

  2. 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).

  3. 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).

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 12, 2024
Registry last updated
Oct 15, 2024

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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