Effect of TENS in Children With Spastic Cerebral Palsy

NCT05649254 | Unknown

• 1 other identifier: TENS IN CP CHILDREN
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Palsy

Keywords

TENS

Outcome Measures

Primary Outcomes (1)

• MUSCLE TONE that will be measured subjectively by modified ashwoth scale

  the study will assess if TENS have effect on muscle tone or not the tone will be measured subjectivly by using modified ashworth scale . The Modified Ashworth scale evaluation involves the rater manually moving a limb through the range of motion to passively stretch specific muscle groups and a six-point ordinal scale for grading the resistance encountered during such passive muscle stretching. MAS grades of spasticity are as follows: 0 = normal muscle tone; 1=slight increase in muscle tone, manifested by catch and release or by minimal resistance at the end; 1+=slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout; 2=more marked increase in muscle tone, but limb easily flexed; 3=considerable increase in muscle tone, passive movement difficult; and 4 = limb rigid in flexion or extension.

  Baseline

Study Arms (2)

study group

in which TENS application will be applied

Control group

placebo treatment

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

children diagnosed with spastic cerebral palsy diplgeia of both sexes will be selected from El-Menshawy public governmental hospital in Tanta City following the official rules and after gaining the agreements of the parents and explaining the aim and procedures of the study.

You may qualify if:

• The children will be included in this study is according to the following criteria
• Cerebral palsy spastic diaplegia.
• Their age ranged from 3-10 years.
• Both Sexes were included.
• The subjects with mild to moderate muscle tone according to MAS in which mild is 1 and 1+ , and moderate is 2.

You may not qualify if:

• The subject will be excluded if he/she has one or more of the following criteria:
• Children with a history of seizures.
• Children who could not lie prone for any cause.
• Children who could not react to pain.
• Children who had applied any surgical procedure which affect muscle tone or any inhibitory injections like BOTOX.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical therapy Cairo university

Giza, Dokki, 3387722, Egypt

RECRUITING

Related Publications (2)

• 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.

  PMID: 26829077 BACKGROUND

• 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.

  PMID: 16034227 RESULT

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Asmaa Osama Sayed, Phd

  Assistant Professor at Cairo university

  STUDY DIRECTOR

Central Study Contacts

Amgad Elwy Hussein, Bachelor

CONTACT

00201100516508; amgad.elwy.hussein@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 14, 2022
• Study Start: November 30, 2022
• Primary Completion: May 1, 2023
• Study Completion: June 1, 2023
• Last Updated: April 4, 2023

Record last verified: 2023-03

Locations

EG (1)