Erb's PalsyNCT06303427
Effects of Modified Constraint-induced Movement Therapy With and Without Electrical Stimulation in Erb's Palsy
A study testing Modified constraint-induced movement therapy and Electrical stimulation in people with Erb's Palsy, run by Riphah International University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Erb's Palsy
- What is being tested?
- Modified constraint-induced movement therapy and Electrical stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Mar 2024to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54660
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Erb's Palsy
- Being tested
- Modified constraint-induced movement therapy, Electrical stimulation
- Keywords
- Erb's Palsy, Erb Paralysis, Electric Stimulation, Active movement scale, Randomized clinical trial, Motor function
- Medical subject headings
- Brachial Plexus Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified constraint-induced movement therapyOther
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.
- Playing with ball.
- Playing with modeling clay.
- Playing with LEGOS (building towers or different shapes from the toy bricks).
- Tearing a paper towel from a roll.
- Holding and eating biscuits.
- Eating with a spoon.
- Drinking from a glass.
- Combing hair.
- Brushing teeth.
- Making bubbles using a bubble blower.
- Pulling a toy.
- Placing a hat or piece of cloth on the head.
- Applying lotion to the trained caregiver.
Electrical stimulationOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Modified constraint-induced movement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start15 Mar 2024
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Erb's PalsyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, PhD-PT, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303427
- Sponsor's protocol ID
- REC/RCR & AHS/23/0292
- Status last verified
- Oct 2024
- First submitted
- 4 Mar 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31814455Coroneos 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.
PubMed 28132014Frade 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.
PubMed 31284431Palomo 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.
PubMed 32583409Sicari 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.
PubMed 34747579Chang 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.
PubMed 23930602Van 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.
PubMed 31670385de 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.
PubMed 35848401Lewis 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.
PubMed 36659827Eren 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.
PubMed 32151503Brady K, Garcia T. Constraint-induced movement therapy (CIMT): pediatric applications. Dev Disabil Res Rev. 2009;15(2):102-11. doi: 10.1002/ddrr.59.
PubMed 19489088
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06303427
- Acronym / sponsor ID
- REC/RCR & AHS/23/0292
- Conditions
- Erb's Palsy
- Keywords
- Erb's Palsy, Erb Paralysis, Electric Stimulation, Active movement scale, Randomized clinical trial, Motor function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: (Modified constraint-induced movement therapy + electrical stimulation) | Experimental | Other: Modified constraint-induced movement therapy, Other: Electrical stimulationGroup 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) | Experimental | Other: Modified constraint-induced movement therapy17 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. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified constraint-induced movement therapyThe 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. | Other | Group A: (Modified constraint-induced movement therapy + electrical stimulation), Group B: (Modified constraint-induced movement therapy) |
| Electrical stimulationThe 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). | Other | Group A: (Modified constraint-induced movement therapy + electrical stimulation) |
Primary outcome
Standard universal goniometer
Time frame: 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.
Medical Research Council (MRC) Scale
Time frame: 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
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Background: PubMed 31814455Zielinski 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.
- Background: PubMed 28132014Coroneos 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.
- Background: PubMed 31284431Frade 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.
- Background: PubMed 32583409Palomo 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.
- Background: PubMed 34747579Sicari 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.
- Background: PubMed 23930602Chang 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.
- Background: PubMed 31670385Van 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.
- Background: PubMed 35848401de 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.
- Background: PubMed 36659827Lewis 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.
- Background: PubMed 32151503Eren 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.
- Background: PubMed 19489088Brady K, Garcia T. Constraint-induced movement therapy (CIMT): pediatric applications. Dev Disabil Res Rev. 2009;15(2):102-11. doi: 10.1002/ddrr.59.
- Individual participant dataSharing planned: No
Related trials for Erb's Palsy
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Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Kashif, PhD-PT study chair
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified constraint-induced movement therapy and Electrical stimulation in people with Erb's Palsy, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard universal goniometer (time frame: 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06303427, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.