Effects of Transcutaneous Electrical Nerve Stimulation on Spasticity in Children With Cerebral Palsy

Study Overview
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Brief Summary
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Cerebral Palsy (CP) is a group of mental disorder that disrupts the person's ability of moving, maintaining their balance and posture. Cerebral palsy is a motor disorganization in Childhood. Cerebral palsy can occur before birth, during birth, within a month after birth, or during 1st year of life when brain is under development. Symptoms vary from person to person in case of severe CP child must needs the equipment used to enhance their mobility and to train muscles. Transcutaneous electrical nerve stimulation (TENS) is method of relieving pain by using mild electric current. Purpose of this study will be to determine effects of TENS on spasticity and gross motor function in children with cerebral palsy. TENS is a small machine operated with battery containing attached sticky pads known as electrodes placed on stiffed and painful area of muscles. Classified by Ashworth Scale and Modified Tardieu Scale. Subjects will be randomly divided into four groups 1) Group A= TENS on spastic muscle/agonist, 2) Group B= TENS on antagonist, 3) GroupC= TENS on both agonist and antagonist muscle, Group D= conventional physiotherapy total treatment period is about 3 to 6 weeks. This study will help to discuss how much extent TENS will effect spasticity in children with cerebral palsy. Data will be analyzed through SPSS 22

Official Title
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Effects of Transcutaneous Electrical Nerve Stimulation on Spasticity in Children With Cerebral Palsy

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Other: Transcutaneous electrical nerve stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 6-12 Both Male and Female Spastic Cerebral Palsy Exclusion Criteria: Patients with History of uncontrolled seizures Patients undergoing previous tendon lengthening surgery History of Botox Injection

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>participants in this group will be given with TENS to spastic Hams, Adductor and TA along with stretchings and ROM as baseline treatment | Other: Transcutaneous electrical nerve stimulation<br>* All children received 30 min of conventional TENS (continuous stimulation with all parameters constant) with a frequency of 100 Hz and a pulse width of 200 µs.<br>|
| Active Comparator: Group B<br>participants in this group will be given with TENS to opposite of spastic muscles, i.e. quards, abductor and dorsiflexors along with stretchings and ROM as baseline treatment | Other: Transcutaneous electrical nerve stimulation<br>* All children received 30 min of conventional TENS (continuous stimulation with all parameters constant) with a frequency of 100 Hz and a pulse width of 200 µs.<br>|
| Active Comparator: Group C<br>participants in this group will be given with TENS to both spastic muscles and opposite of spastic muscle along with stretchings and ROM as baseline treatment | Other: Transcutaneous electrical nerve stimulation<br>* All children received 30 min of conventional TENS (continuous stimulation with all parameters constant) with a frequency of 100 Hz and a pulse width of 200 µs.<br>|
| Active Comparator: Group D<br>participants in this group will be given with stretchings and ROM as baseline treatment | Other: Transcutaneous electrical nerve stimulation<br>* All children received 30 min of conventional TENS (continuous stimulation with all parameters constant) with a frequency of 100 Hz and a pulse width of 200 µs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Modified Ashworth Scale | The modified Ashworth scale(MAS) is a 6-point rating scale that is used to measure muscle tone. 0 No increase in tone 1 slight increase in tone giving a catch when slight increase in muscle tone, manifested by the limb was moved in flexion or extension. 1+ slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout (ROM ) 2 more marked increase in tone but more marked increased in muscle tone through most limb easily flexed 3 considerable increase in tone, passive movement difficult 4 limb rigid in flexion or extension | Baseline and 4th week | 
| Change in Modified Tardieu Scale | The Modified Tardieu Scale (MTS) is an often-recommended spasticity assessment.The MTS classifies the response of a relaxed muscle to a fast, passive stretch (V3). The assessment protocol involves a clinician moving the joint as fast as possible through its full range of motion (ROM) without specifying or measuring the speed of completion. The MTS is applied according to this standardized protocol regardless of the functional status or goals of the patient. | Baseline and 4th week |