Erb's PalsyNCT05723042
Neuromuscular Electrical Stimulation With and Without Constraint Induced Movement Therapy in Erb's Palsy
A study testing EMS with CIMT and EMS in people with Erb's Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Erb's Duchenne paralysis constitutes the single commonest form of brachial plexus injury, brachial plexus injury (BPI) is unfortunately a rather common injury in newborn children. Incidence varies between 0.15 and 3 per 1000 live births in various series and countries. 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?
- EMS with CIMT and EMS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Jan 2023to 28 Mar 2023
- 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
- Aged between 2.5 to 8 years years
- Clinically diagnosed with erb's palsy/brachial plexus palsy
- Ability to cooperate with assessments and therapy
- Full passive ROMs in all motions at the shoulder, elbow, and wrist joints
Who cannot join
- Cognitive impairment
- Contracture in the affected upper extremity
- Injured unaffected arm
- Visual problems likely to interfere with treatment/testing
- Previous orthopedic or neurological surgery
- Previous application of CIMT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Neuromuscular Electrical Stimulation With and Without Constraint Induced Movement Therapy on Upper Limb Function in Children With Erb's Palsy
Erb's Duchenne paralysis constitutes the single commonest form of brachial plexus injury, brachial plexus injury (BPI) is unfortunately a rather common injury in newborn children. Incidence varies between 0.15 and 3 per 1000 live births in various series and countries. The constraint-induced movement therapy (CIMT) has been used to promote functional gains in individuals with neurological dysfunctions .The constraint-induced movement therapy consists of constraining movement of the non-affected upper extremity and providing intensive training to the involved upper extremity. Neuromuscular electrical stimulation (NMES) has been used for muscle strengthening, maintenance of muscle mass and strength during prolonged periods of immobilisation, selective muscle retraining, and the control of oedema.The aim of this study is to compare the effects of Neuromuscular Electrical Stimulation with and without Constraint Induced Movement Therapy on Upper limb Function in Children with Erb's Palsy.
It is a Randomized Controlled Trial.The sample size calculated by using OpenEpi or GPower. Data will be collected from Jinnah Hospital,Children Hospital,Lahore medical city hospital,Farooq hospital,Rising sun institute and PSRD. The patients will be selected through non-probability convenience sampling,will be divided into two groups. The Group A will receive habituation exercises for six weeks, three times per week for thirty minutes, along with application of neuromuscular electrical stimulation for a period of 6 weeks four times a week and perform Constrained induced movement therapy techniques, each for 8 weeks.The interventions are consisted of 3weeks of casting the unaffected limb followed by 5 weeks of transference activities.. The Group B will be given neuromuscular electrical stimulation for a period of 6 weeks four times a week.Range of motion ,Flexibility exercises will be given as baseline treatment to both groups. The arm function was evaluated by the Mallet score system, while active abduction and external rotation range of motion were measured by a standard universal goniometer. Data will be analyzed by SPSS 25.
- Conditions
- Erb's Palsy
- Being tested
- EMS with CIMT, EMS
- 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.
EMS with CIMTOther
The interventions are consisted of 3weeks of casting the unaffected limb followed by 5 weeks of transference activities.The assisting hand assessment AHA was used to measure bimanual activity performance at baseline,8 weeks, 16 weeks. 20-minute application of currents and resistance exercises for the respective muscles of the area. The intervention group with 11 patients underwent a program of CIMT for one hour daily for 14 consecutive days or two hours per day, six days per week and a total of 12 weeks. A follow-up will be performed 12 weeks after the intervention. The healthy upper limb will be immobilized by orthosis or cast for six hours a day . Electrotherapy will be applied with TENS for 15 minutes at intervals of 1000ms and with a pulse duration of 50ms. The square wave will be chosen to ensure that there will be sufficient muscle contraction
EMSOther
this group will only receive baseline exercises (ROM and flexibility exercises) than apply electrical stimulations at specific motor points. Electrotherapy will be applied with TENS for 15 minutes at intervals of 1000ms and with a pulse duration of 50ms. The square wave will be chosen to ensure that there will be sufficient muscle contraction
| Study group | Role | What they receive |
|---|---|---|
| EMS with CIMT group | Experimental | Not described Receives: Other: EMS with CIMT |
| EMS Group | Active comparator | Not described Receives: Other: EMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mallet scale Scores
The Mallet grading remains the most commonly used system in several obstetric brachial plexus centers. One feature of the Mallet score is that each grade is translated into certain degrees of deficiencies in both shoulder abduction and external rotation.
Measured: Baseline, 8th week and 16th week
Change in Box and block test scores
the BBT has been commonly used in the pediatric field. It is particularly suitable for children for several reasons. First, the evaluation method of the BBT examines essential components of manual dexterity for developing children, such as grasping, holdi
Measured: Baseline, 8th week and 16th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start13 Jan 2023
- Primary completion1 Mar 2023
- Study completion28 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muneeb Iqbal, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723042
- Sponsor's protocol ID
- REC/RCR & AHS/22/0749
- Status last verified
- Jun 2023
- First submitted
- 24 Jan 2023
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gonçalves RV, Araujo RCd, Ferreira VKG. Effect of reaching training combined with electrical stimulation in infants with brachial plexus palsy: a single subject design. Fisioterapia e Pesquisa. 2021;28:32-8.
Justice D, Awori J, Carlson S, Chang KW, Yang LJ. Use of neuromuscular electrical stimulation in the treatment of neonatal brachial plexus palsy: A literature review. The Open Journal of Occupational Therapy. 2018;6(3):10
Sakzewski L, Ziviani J, Boyd R. Systematic review and meta-analysis of therapeutic management of upper-limb dysfunction in children with congenital hemiplegia. Pediatrics. 2009 Jun;123(6):e1111-22. doi: 10.1542/peds.2008-3335. Epub 2009 May 18.
PubMed 19451190
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neuromuscular Electrical Stimulation With and Without Constraint Induced Movement Therapy on Upper Limb Function in Children With Erb's Palsy
- ClinicalTrials.gov ID
- NCT05723042
- Acronym / sponsor ID
- REC/RCR & AHS/22/0749
- Conditions
- Erb's Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 10 Feb 2023 (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 Duchenne paralysis constitutes the single commonest form of brachial plexus injury, brachial plexus injury (BPI) is unfortunately a rather common injury in newborn children. Incidence varies between 0.15 and 3 per 1000 live births in various series and countries. The constraint-induced movement therapy (CIMT) has been used to promote functional gains in individuals with neurological dysfunctions .The constraint-induced movement therapy consists of constraining movement of the non-affected upper extremity and providing intensive training to the involved upper extremity. Neuromuscular electrical stimulation (NMES) has been used for muscle strengthening, maintenance of muscle mass and strength during prolonged periods of immobilisation, selective muscle retraining, and the control of oedema.The aim of this study is to compare the effects of Neuromuscular Electrical Stimulation with and without Constraint Induced Movement Therapy on Upper limb Function in Children with Erb's Palsy.
It is a Randomized Controlled Trial.The sample size calculated by using OpenEpi or GPower. Data will be collected from Jinnah Hospital,Children Hospital,Lahore medical city hospital,Farooq hospital,Rising sun institute and PSRD. The patients will be selected through non-probability convenience sampling,will be divided into two groups. The Group A will receive habituation exercises for six weeks, three times per week for thirty minutes, along with application of neuromuscular electrical stimulation for a period of 6 weeks four times a week and perform Constrained induced movement therapy techniques, each for 8 weeks.The interventions are consisted of 3weeks of casting the unaffected limb followed by 5 weeks of transference activities.. The Group B will be given neuromuscular electrical stimulation for a period of 6 weeks four times a week.Range of motion ,Flexibility exercises will be given as baseline treatment to both groups. The arm function was evaluated by the Mallet score system, while active abduction and external rotation range of motion were measured by a standard universal goniometer. Data will be analyzed by SPSS 25.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMS with CIMT group | Experimental | Other: EMS with CIMT |
| EMS Group | Active comparator | Other: EMS |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Aged between 2.5 to 8 years years
- Clinically diagnosed with erb's palsy/brachial plexus palsy
- Ability to cooperate with assessments and therapy
- Full passive ROMs in all motions at the shoulder, elbow, and wrist joints
Key exclusion criteria (6 listed)
- Cognitive impairment
- Contracture in the affected upper extremity
- Injured unaffected arm
- Visual problems likely to interfere with treatment/testing
- Previous orthopedic or neurological 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 |
|---|---|---|
| EMS with CIMTThe interventions are consisted of 3weeks of casting the unaffected limb followed by 5 weeks of transference activities.The assisting hand assessment AHA was used to measure bimanual activity performance at baseline,8 weeks, 16 weeks. 20-minute application of currents and resistance exercises for the respective muscles of the area. The intervention group with 11 patients underwent a program of CIMT for one hour daily for 14 consecutive days or two hours per day, six days per week and a total of 12 weeks. A follow-up will be performed 12 weeks after the intervention. The healthy upper limb will be immobilized by orthosis or cast for six hours a day . Electrotherapy will be applied with TENS for 15 minutes at intervals of 1000ms and with a pulse duration of 50ms. The square wave will be chosen to ensure that there will be sufficient muscle contraction | Other | EMS with CIMT group |
| EMSthis group will only receive baseline exercises (ROM and flexibility exercises) than apply electrical stimulations at specific motor points. Electrotherapy will be applied with TENS for 15 minutes at intervals of 1000ms and with a pulse duration of 50ms. The square wave will be chosen to ensure that there will be sufficient muscle contraction | Other | EMS Group |
Primary outcome
Change in Mallet scale Scores
Time frame: Baseline, 8th week and 16th week
The Mallet grading remains the most commonly used system in several obstetric brachial plexus centers. One feature of the Mallet score is that each grade is translated into certain degrees of deficiencies in both shoulder abduction and external rotation.
Change in Box and block test scores
Time frame: Baseline, 8th week and 16th week
the BBT has been commonly used in the pediatric field. It is particularly suitable for children for several reasons. First, the evaluation method of the BBT examines essential components of manual dexterity for developing children, such as grasping, holdi
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 28 Jun 2023.
- BackgroundGonçalves RV, Araujo RCd, Ferreira VKG. Effect of reaching training combined with electrical stimulation in infants with brachial plexus palsy: a single subject design. Fisioterapia e Pesquisa. 2021;28:32-8.
- BackgroundJustice D, Awori J, Carlson S, Chang KW, Yang LJ. Use of neuromuscular electrical stimulation in the treatment of neonatal brachial plexus palsy: A literature review. The Open Journal of Occupational Therapy. 2018;6(3):10
- Background: PubMed 19451190Sakzewski L, Ziviani J, Boyd R. Systematic review and meta-analysis of therapeutic management of upper-limb dysfunction in children with congenital hemiplegia. Pediatrics. 2009 Jun;123(6):e1111-22. doi: 10.1542/peds.2008-3335. Epub 2009 May 18.
- Individual participant dataSharing planned: No
Related trials for Erb's Palsy
Not yet recruitingObservational study
Investigation of the Relationship Between Shoulder Alpha Angle and Humeral Head Displacement Percentage Measured by Ultrasonography in Neonatal Brachial Plexus Palsy Infants With Clinical Parameters
Glenohumeral Subluxation, Neonatal Brachial Plexus Palsy
Recruiting
Pilot Test of Caregiver Training Protocol for Brachial Plexus Birth Injury
Brachial Plexus Birth Palsy, Erbs Palsy
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.
Muneeb Iqbal, PhD principal investigator
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 EMS with CIMT and EMS 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 4 inclusion and 6 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 28 Jun 2023. 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?
Change in Mallet scale Scores (time frame: Baseline, 8th week and 16th week). The study lists 2 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 NCT05723042, which also lists 3 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 28 Jun 2023.