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

Riphah International University

Status: Completed

Conditions: Erb's Palsy

Treatments: Other: Modified constraint-induced movement therapy; Other: Electrical stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06303427

REC/RCR & AHS/23/0292

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 2 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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34 participants in 2 patient groups

Group A: (Modified constraint-induced movement therapy + electrical stimulation)

Experimental group

Description:

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.

Treatment:

Other: Electrical stimulation

Other: Modified constraint-induced movement therapy

Group B: (Modified constraint-induced movement therapy)

Experimental group

Description:

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.

Treatment:

Other: Modified constraint-induced movement therapy