NCT05723042

Neuromuscular Electrical Stimulation With and Without Constraint Induced Movement Therapy in Erb's Palsy

Completed NA Last updated 28 June 2023

What this trial tests

NA trial testing EMS with CIMT in Erb's Palsy in 22 participants. Completed in 28 March 2023.

Timeline

13 January 2023

Primary endpoint
1 March 2023

28 March 2023

Quick facts

Lead sponsor	Riphah International University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	22
Start date	13 January 2023
Primary completion	1 March 2023
Estimated completion	28 March 2023
Sites	1 location across Pakistan

Drugs / interventions tested

• EMS with CIMT
• EMS

Conditions studied

• Erb's Palsy — all drugs for Erb's Palsy →

Sponsor

Riphah International University

Who can join

Adults 2 to 6, any sex, with Erb's Palsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.