Clinical trial NCT05649254: Effect of TENS in Children With Spastic Cerebral Palsy
Official title: Immediate Effect of Transcutaneous Electrical Nerve Stimulation on Muscle Tone in Children With Spastic Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Palsy
Keywords: TENS
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 22
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: MUSCLE TONE that will be measured subjectively by modified ashwoth scale
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy Cairo university
state: Dokki
Study officials:
affiliation: Assistant Professor at Cairo university
name: Asmaa Osama Sayed, Phd
role: STUDY_DIRECTOR
References:
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.
citation: 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.