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Cerebral PalsyNCT05463159

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

A study testing Transcutaneous electrical nerve stimulation in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 12 years
Conditions the study is for
Cerebral Palsy
What is being tested?
Transcutaneous electrical nerve stimulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 sitePakistan
Study dates
13 Jan 2022to 15 Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Imran Amjad, Ph.D contact

03324390125

imran.amjad@riphah.edu.pk

Fareeha Kausar, PP-DPT contact

03216758180

fareeha.kausar@riphah.edu.pk

Pakistan1 site, 1 recruiting

  • DHQ Hospital

    Vehari, Punjab Province, 61100

    Fareeha Kausar, PP-DPT, 03216758180, fareeha.kausar@riphah.edu.pk

    Aden Riaz, MSPT (Pead)

    Recruiting

Other trials in Pakistan

About this study

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
Being tested
Transcutaneous electrical nerve stimulation
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT05463159
Study groupRoleWhat they receive
Group AExperimentalparticipants in this group will be given with TENS to spastic Hams, Adductor and TA along with stretchings and ROM as baseline treatment
Receives: Other: Transcutaneous electrical nerve stimulation
Group BActive comparatorparticipants 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
Receives: Other: Transcutaneous electrical nerve stimulation
Group CActive comparatorparticipants 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
Receives: Other: Transcutaneous electrical nerve stimulation
Group DActive comparatorparticipants in this group will be given with stretchings and ROM as baseline treatment
Receives: Other: Transcutaneous electrical nerve stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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.

    Measured: Baseline and 4th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2022
  2. Study start13 Jan 2022
  3. Primary completion30 Jul 2022 (estimated)
  4. Study completion15 Aug 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05463159
Sponsor's protocol ID
REC/RCR & AHS/22/0708
Status last verified
Jul 2022
First submitted
20 Jun 2022
Last updated
18 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Transcutaneous electrical nerve stimulation in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Imran Amjad, Ph.D (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Modified Ashworth Scale (time frame: Baseline and 4th week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05463159, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.

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