Effect of TENS in Children With Spastic Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Immediate Effect of Transcutaneous Electrical Nerve Stimulation on Muscle Tone in Children With Spastic Cerebral Palsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05649254
• Other study ID #: TENS IN CP CHILDREN
• Status: Recruiting
• Start date: November 30, 2022
• Est. completion date: June 2023

Study information

• Verified date: March 2023
• Source: Cairo University
• Contact: Amgad Elwy Hussein, Bachelor
• Phone: 00201100516508
• Email: amgad.elwy.hussein[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: June 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy

Locations

Country	Name	City	State
Egypt	Faculty of physical therapy Cairo university	Giza	Dokki

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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