Effects of Modified Constraint-induced Movement Therapy With and Without Electrical Stimulation in Erb's Palsy
NCT ID: NCT06303427
Last Updated: 2024-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
34 participants
INTERVENTIONAL
2024-03-15
2024-10-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group A: (Modified constraint-induced movement therapy + 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.
Modified constraint-induced movement therapy
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.
Electrical 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).
Group B: (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.
Modified constraint-induced movement therapy
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.
Interventions
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Modified constraint-induced movement therapy
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.
Electrical 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).
Eligibility Criteria
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Inclusion Criteria
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
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
2 Years
6 Years
ALL
No
Sponsors
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Riphah International University
OTHER
Responsible Party
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Principal Investigators
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Muhammad Kashif, PhD-PT
Role: STUDY_CHAIR
Riphah International University
Locations
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Riphah International University
Lahore, Punjab Province, Pakistan
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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REC/RCR & AHS/23/0292
Identifier Type: -
Identifier Source: org_study_id
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