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

Sponsor
Riphah International University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05463159
Collaborator
(none)
40
1
4
7
5.7

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Transcutaneous electrical nerve stimulation
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effects of Transcutaneous Electrical Nerve Stimulation on Spasticity in Children With Cerebral Palsy
Actual Study Start Date :
Jan 13, 2022
Anticipated Primary Completion Date :
Jul 30, 2022
Anticipated Study Completion Date :
Aug 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A

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
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.

Active Comparator: Group B

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
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.

Active Comparator: Group C

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
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.

Active Comparator: Group D

participants in this group will be given with stretchings and ROM as baseline treatment

Other: Transcutaneous electrical nerve stimulation
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.

Outcome Measures

Primary Outcome Measures

  1. Change in Modified Ashworth Scale [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

  2. Change in Modified Tardieu Scale [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 DHQ Hospital Vehari Punjab Pakistan 61100

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: Fareeha Kausar, PP-DPT, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT05463159
Other Study ID Numbers:
  • REC/RCR & AHS/22/0708
First Posted:
Jul 18, 2022
Last Update Posted:
Jul 18, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 18, 2022