Effect of TENS in Children With Spastic Cerebral Palsy

NCT ID: NCT05649254

Last Updated: 2023-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-30

Study Completion Date

2023-06-30

Brief Summary

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TENS is cheap and simple tool for physiotherapist, free of many side effects compared with other tools. so The aim of study was record the effect of TENS on calf muscle tone in spastic cerebral palsy children.

Detailed Description

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The Significance of this study is to determine whether TENS could have an immediate effect on reduction of spasticity in children diagnosed with spastic cerebral palsy by studying the change of spasticity of ankle plantarflexors immediately after applying TENS to the ankle dorsiflexors.

Muscle tone assessment will be applied before and after the application using objective tool which is electromyography and subjectively by using modified Ashworth scale and goniometer, to be insured is there is an immediate effect of TENS on muscle tone of calf muscle or not.

Conditions

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Cerebral Palsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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study group

in which TENS application will be applied

No interventions assigned to this group

Control group

placebo treatment

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* The children will be included in this study is according to the following criteria

1. Cerebral palsy spastic diaplegia.
2. Their age ranged from 3-10 years.
3. Both Sexes were included.
4. The subjects with mild to moderate muscle tone according to MAS in which mild is 1 and 1+ , and moderate is 2.

Exclusion Criteria

* The subject will be excluded if he/she has one or more of the following criteria:

1. Children with a history of seizures.
2. Children who could not lie prone for any cause.
3. Children who could not react to pain.
4. Children who had applied any surgical procedure which affect muscle tone or any inhibitory injections like BOTOX.
Minimum Eligible Age

3 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Amgad Elwy Ali Hussein

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Asmaa Osama Sayed, Phd

Role: STUDY_DIRECTOR

Assistant Professor at Cairo university

Locations

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Faculty of physical therapy Cairo university

Giza, Dokki, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Amgad Elwy Hussein, Bachelor

Role: CONTACT

00201100516508

References

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Mills PB, Dossa F. Transcutaneous Electrical Nerve Stimulation for Management of Limb Spasticity: A Systematic Review. Am J Phys Med Rehabil. 2016 Apr;95(4):309-18. doi: 10.1097/PHM.0000000000000437.

Reference Type BACKGROUND
PMID: 26829077 (View on PubMed)

Aydin G, Tomruk S, Keles I, Demir SO, Orkun S. Transcutaneous electrical nerve stimulation versus baclofen in spasticity: clinical and electrophysiologic comparison. Am J Phys Med Rehabil. 2005 Aug;84(8):584-92. doi: 10.1097/01.phm.0000171173.86312.69.

Reference Type RESULT
PMID: 16034227 (View on PubMed)

Other Identifiers

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TENS IN CP CHILDREN

Identifier Type: -

Identifier Source: org_study_id

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