Effects of Modified Constraint-induced Movement Therapy With and Without Electrical Stimulation in Erb's Palsy
- Conditions
- Erb's Palsy
- Interventions
- Other: Modified constraint-induced movement therapyOther: Electrical stimulation
- Registration Number
- NCT06303427
- Lead Sponsor
- Riphah International University
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A: (Modified constraint-induced movement therapy + electrical stimulation) 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. Group A: (Modified constraint-induced movement therapy + electrical stimulation) Modified constraint-induced movement therapy 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. Group B: (Modified constraint-induced movement therapy) 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.
- Primary Outcome Measures
Name Time Method Medical Research Council (MRC) Scale 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).
Active Movement Scale 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).
Standard universal goniometer 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Riphah International University
🇵🇰Lahore, Punjab, Pakistan