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

NCT ID: NCT05463159

Last Updated: 2022-07-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-13
• Study Completion Date: 2022-08-15

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

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Transcutaneous electrical nerve stimulation

Intervention Type: OTHER

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 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

Group Type: ACTIVE_COMPARATOR

Transcutaneous electrical nerve stimulation

Intervention Type: OTHER

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 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

Group Type: ACTIVE_COMPARATOR

Transcutaneous electrical nerve stimulation

Intervention Type: OTHER

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 D

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

Group Type: ACTIVE_COMPARATOR

Transcutaneous electrical nerve stimulation

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fareeha Kausar, PP-DPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

DHQ Hospital

Vehari, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Imran Amjad, Ph.D

Role: CONTACT

imran.amjad@riphah.edu.pk

03324390125

Fareeha Kausar, PP-DPT

Role: CONTACT

fareeha.kausar@riphah.edu.pk

03216758180

Facility Contacts

Fareeha Kausar, PP-DPT

Role: primary

fareeha.kausar@riphah.edu.pk

03216758180

References

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Reference Type: BACKGROUND

PMID: 30913943 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28063935 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30061001 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21876294 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20203376 (View on PubMed)

Other Identifiers

REC/RCR & AHS/22/0708

Identifier Type: -

Identifier Source: org_study_id