CClinicalTrials.gg
Status unknownNCT05463159Updated Jul 18, 2022

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

An interventional study of Transcutaneous electrical nerve stimulation in Cerebral Palsy, sponsored by Riphah International University. Status unknown at 1 site in Pakistan. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2022-07-18.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jan 2022, registered Jun 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
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Study 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

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Conditions studied

  • Cerebral Palsy

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03

In context

Cerebral Palsy

1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.

This study's planned enrollment of 40 is above the median of 33 across 1,368 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (estimated)

Study arms

  • 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

  • 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

  • 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

  • Active comparator
    Group D

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

    Other: Transcutaneous electrical nerve stimulation

Interventions

  • OtherTranscutaneous 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.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline and 4th week

  2. 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.

    Time frame: Baseline and 4th week

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Study locations

1 of 1 sites recruiting
  • DHQ Hospital
    Vehari, Punjab 61100, Pakistan
    Recruiting
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References and documents

Publications

  • 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. PubMed 30913943 ↗
  • 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. PubMed 28063935 ↗
  • 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. PubMed 30061001 ↗
  • 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. PubMed 21876294 ↗
  • 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. PubMed 20203376 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05463159
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Jul 18, 2022
Start date
Jan 13, 2022
Primary completion
Jul 30, 2022 (estimated)
Completion
Aug 15, 2022 (estimated)
Last update
Jul 18, 2022

Study contacts

Imran Amjad, Ph.D
Contact
imran.amjad@riphah.edu.pk
03324390125
Fareeha Kausar, PP-DPT
Contact
fareeha.kausar@riphah.edu.pk
03216758180
Fareeha Kausar, PP-DPT
principal investigator · Riphah International University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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