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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06303427
Enrollment
34
Registered
2024-03-12
Start date
2024-03-15
Completion date
2024-10-01
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erb's Palsy

Keywords

Erb's Palsy, Erb Paralysis, Electric Stimulation, Active movement scale, Randomized clinical trial, Motor function

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.

Interventions

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.

OTHERElectrical 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).

Sponsors

Riphah International University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The study would be single-blinded as the assessor of the study would be kept blind to the treatment groups to which patients will be allocated.

Eligibility

Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Standard universal goniometer16 weeksIt is a device used to measure the range of motion of joints. It consists of four parts: body, fulcrum, stationary, and the moving arm.
Medical Research Council (MRC) Scale16 weeksIt 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 Scale16 weeksIt 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).

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026