NCT05463159

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 18, 2022

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2022

Completed
Last Updated

July 18, 2022

Status Verified

July 1, 2022

Enrollment Period

7 months

First QC Date

June 20, 2022

Last Update Submit

July 14, 2022

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (4)

Group A

EXPERIMENTAL

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

Group B

ACTIVE COMPARATOR

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

Group C

ACTIVE COMPARATOR

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

Group D

ACTIVE COMPARATOR

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

Other: Transcutaneous electrical nerve stimulation

Interventions

Transcutaneous electrical nerve stimulationOTHER

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.

Group AGroup BGroup CGroup D

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 6-12
  • Both Male and Female
  • Spastic Cerebral Palsy

You may not qualify if:

  • Patients with History of uncontrolled seizures
  • Patients undergoing previous tendon lengthening surgery
  • History of Botox Injection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DHQ Hospital

Vehari, Punjab Province, 61100, Pakistan

RECRUITING

Related Publications (5)

  • Alhusaini AA, Fallatah S, Melam GR, Buragadda S. Efficacy of transcutaneous electrical nerve stimulation combined with therapeutic exercise on hand function in children with hemiplegic cerebral palsy. Somatosens Mot Res. 2019 Mar;36(1):49-55. doi: 10.1080/08990220.2019.1584555. Epub 2019 Mar 26.

    PMID: 30913943BACKGROUND

  • Solopova IA, Sukhotina IA, Zhvansky DS, Ikoeva GA, Vissarionov SV, Baindurashvili AG, Edgerton VR, Gerasimenko YP, Moshonkina TR. Effects of spinal cord stimulation on motor functions in children with cerebral palsy. Neurosci Lett. 2017 Feb 3;639:192-198. doi: 10.1016/j.neulet.2017.01.003. Epub 2017 Jan 4.

    PMID: 28063935BACKGROUND

  • Bakaniene I, Urbonaviciene G, Janaviciute K, Prasauskiene A. Effects of the Inerventions method on gross motor function in children with spastic cerebral palsy. Neurol Neurochir Pol. 2018 Sep-Oct;52(5):581-586. doi: 10.1016/j.pjnns.2018.07.003. Epub 2018 Jul 20.

    PMID: 30061001BACKGROUND

  • Alabdulwahab SS. Electrical stimulation improves gait in children with spastic diplegic cerebral palsy. NeuroRehabilitation. 2011;29(1):37-43. doi: 10.3233/NRE-2011-0675.

    PMID: 21876294BACKGROUND

  • Alabdulwahab SS, Al-Gabbani M. Transcutaneous electrical nerve stimulation of hip adductors improves gait parameters of children with spastic diplegic cerebral palsy. NeuroRehabilitation. 2010;26(2):115-22. doi: 10.3233/NRE-2010-0542.

    PMID: 20203376BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Fareeha Kausar, PP-DPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, Ph.D

CONTACT

03324390125imran.amjad@riphah.edu.pk

Fareeha Kausar, PP-DPT

CONTACT

03216758180fareeha.kausar@riphah.edu.pk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2022

First Posted

July 18, 2022

Study Start

January 13, 2022

Primary Completion

July 30, 2022

Study Completion

August 15, 2022

Last Updated

July 18, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)