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

NCT06303427 | Completed DMC

• 1 other identifier: REC/RCR & AHS/23/0292
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Erb's Palsy

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Standard universal goniometer

  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

  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

  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

Study Arms (2)

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

EXPERIMENTAL

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; Other: Electrical stimulation

Group B: (Modified constraint-induced movement therapy)

EXPERIMENTAL

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

Interventions

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. 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.

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

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).

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

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54660, Pakistan

Location

Related Publications (11)

• Zielinski IM, van Delft R, Voorman JM, Geurts ACH, Steenbergen B, Aarts PBM. The effects of modified constraint-induced movement therapy combined with intensive bimanual training in children with brachial plexus birth injury: a retrospective data base study. Disabil Rehabil. 2021 Aug;43(16):2275-2284. doi: 10.1080/09638288.2019.1697381. Epub 2019 Dec 8.

  PMID: 31814455 BACKGROUND

• Coroneos CJ, Voineskos SH, Christakis MK, Thoma A, Bain JR, Brouwers MC; Canadian OBPI Working Group. Obstetrical brachial plexus injury (OBPI): Canada's national clinical practice guideline. BMJ Open. 2017 Jan 27;7(1):e014141. doi: 10.1136/bmjopen-2016-014141.

  PMID: 28132014 BACKGROUND

• Frade F, Gomez-Salgado J, Jacobsohn L, Florindo-Silva F. Rehabilitation of Neonatal Brachial Plexus Palsy: Integrative Literature Review. J Clin Med. 2019 Jul 5;8(7):980. doi: 10.3390/jcm8070980.

  PMID: 31284431 BACKGROUND

• Palomo R, Sanchez R. [Physiotherapy applied to the upper extremity in 0 to 10-year-old children with obstetric brachial palsy: a systematic review]. Rev Neurol. 2020 Jul 1;71(1):1-10. doi: 10.33588/rn.7101.2020029. Spanish.

  PMID: 32583409 BACKGROUND

• Sicari M, Longhi M, D'Angelo G, Boetto V, Lavorato A, Cocchini L, Beatrici M, Battiston B, Garbossa D, Massazza G, Titolo P. Modified constraint induced movement therapy in children with obstetric brachial plexus palsy: a systematic review. Eur J Phys Rehabil Med. 2022 Feb;58(1):43-50. doi: 10.23736/S1973-9087.21.06886-6. Epub 2021 Nov 8.

  PMID: 34747579 BACKGROUND

• Chang KW, Justice D, Chung KC, Yang LJ. A systematic review of evaluation methods for neonatal brachial plexus palsy: a review. J Neurosurg Pediatr. 2013 Oct;12(4):395-405. doi: 10.3171/2013.6.PEDS12630. Epub 2013 Aug 9.

  PMID: 23930602 BACKGROUND

• Van der Looven R, Le Roy L, Tanghe E, Samijn B, Roets E, Pauwels N, Deschepper E, De Muynck M, Vingerhoets G, Van den Broeck C. Risk factors for neonatal brachial plexus palsy: a systematic review and meta-analysis. Dev Med Child Neurol. 2020 Jun;62(6):673-683. doi: 10.1111/dmcn.14381. Epub 2019 Oct 31.

  PMID: 31670385 BACKGROUND

• de Matos MA, Souto DO, Soares BA, de Oliveira VC, Leite HR, Camargos ACR. Effectiveness of Physical Therapy Interventions in Children with Brachial Plexus Birth Injury: A Systematic Review. Dev Neurorehabil. 2023 Jan;26(1):52-62. doi: 10.1080/17518423.2022.2099995. Epub 2022 Jul 17.

  PMID: 35848401 BACKGROUND

• Lewis SP, Sweeney JK. Comorbidities in Infants and Children with Neonatal Brachial Plexus Palsy: A Scoping Review to Inform Multisystem Screening. Phys Occup Ther Pediatr. 2023;43(5):503-527. doi: 10.1080/01942638.2023.2169091. Epub 2023 Jan 19.

  PMID: 36659827 BACKGROUND

• Eren B, Karadag Saygi E, Tokgoz D, Akdeniz Leblebicier M. Modified constraint-induced movement therapy during hospitalization in children with perinatal brachial plexus palsy: A randomized controlled trial. J Hand Ther. 2020 Jul-Sep;33(3):418-425. doi: 10.1016/j.jht.2019.12.008. Epub 2020 Mar 7.

  PMID: 32151503 BACKGROUND

• Brady K, Garcia T. Constraint-induced movement therapy (CIMT): pediatric applications. Dev Disabil Res Rev. 2009;15(2):102-11. doi: 10.1002/ddrr.59.

  PMID: 19489088 BACKGROUND

MeSH Terms

Conditions

Brachial Plexus Neuropathies

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• Muhammad Kashif, PhD-PT

  Riphah International University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 12, 2024
• Study Start: March 15, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)