Clinical trial NCT05723042: Neuromuscular Electrical Stimulation With and Without Constraint Induced Movement Therapy in Erb's Palsy
Official title: Effects of Neuromuscular Electrical Stimulation With and Without Constraint Induced Movement Therapy on Upper Limb Function in Children With Erb's Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erb's Palsy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 22
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Mallet scale Scores
timeFrame: Baseline, 8th week and 16th week
measure: Change in Box and block test scores
timeFrame: Baseline, 8th week and 16th week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Jinnah Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muneeb Iqbal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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
citation: 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.