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Clinical Trials/NCT05463159
NCT05463159
Unknown
Not Applicable

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

Riphah International University1 site in 1 country40 target enrollmentJanuary 13, 2022
ConditionsCerebral Palsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Riphah International University
Enrollment
40
Locations
1
Primary Endpoint
Change in Modified Ashworth Scale
Last Updated
3 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
January 13, 2022
End Date
August 15, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

Change in Modified Ashworth Scale

Time Frame: Baseline and 4th week

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

Change in Modified Tardieu Scale

Time Frame: Baseline and 4th week

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.

Study Sites (1)

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