Clinical trial NCT05352607: Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Spasticity in Adult Patients With Spastic Cerebral Palsy
Official title: Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Upper Limb Spasticity in Adult Patients With Spastic Cerebral Palsy: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral palsy
Adult
Spasticity
Transcutaneous electrical nerve stimulation
TENS
Conventional therapy
Lead sponsor: Umm Al-Qura University
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be 2 groups one is control group will receive a conventional physiotherapy treatment and the second group will receive a conventional physiotherapy treatment plus TENS therapy.
Primary purpose: TREATMENT

Brief summary: Background: Cerebral palsy (CP) is a neurodevelopmental disorder caused by damage of the developing brain and marked by impairments such as increased muscle tone. Physical therapy (PT) is an important element for spasticity management include some modalities as transcutaneous electrical nerve stimulation (TENS).

Purpose: To determine the effect of TENS on inhibition of upper limb spasticity in adult patients with spastic cerebral palsy.

Methods: Twenty-four adult spastic CP patients aged from 18 to 45 years old with grade 2 to 3 spasticity according to Modified Ashworth Scale will be randomly assigned into two equal groups: TENS group and conventional therapy group. Both groups will receive conventional therapy, while TENS group in addition will receive TENS over elbow flexors with parameter setup of (pulse frequency= 100 Hz, pulse duration= 250 μs, time=30 mints) 3 sessions per week for successive 4 weeks.

Outcome measures: Modified Ashworth scale for the spasticity and digital goniometer for elbow joint range of motion, Barthel index scale for upper limb activity of daily living. Follow-up measures will be calculated three times (preintervention, post 2 weeks, and post 4 weeks).


Eligibility criteria: Inclusion Criteria:

* Male and female patients aged from 18 to 45 years old
* Diagnosed with spastic CP (upper limb is affected)
* Elbow flexor muscles spasticity grade 2 to 3 according to Modified Ashworth Scale
* Good cognition (patient able to follow the instruction)

Exclusion Criteria:

* Patient with epilepsy
* Under antispastic medication
* Severe psychological or behavioral problem
* Sensory abnormalities
* Orthopedic surgery or severe deformities in upper limb
* Injected by botulinum toxin (botox) in the past 6 months in upper limb.

Primary outcomes:
measure: Modified Ashworth Scale (MAS) to assess the muscle spasticity changes
timeFrame: Pre intervention ( at baseline) , post 2 weeks and post 4 weeks
measure: Digital goniometer to assess the elbow range of motion changes
timeFrame: Pre intervention( at baseline), post 2 weeks and post 4 weeks
Secondary outcomes:
measure: Barthel Index to assess the activity of daily living changes
timeFrame: Pre intervention ( at baseline) , post 2 weeks and post 4 weeks
Other outcomes:
Locations:
city: Ta'if
country: Saudi Arabia
facility: Reem Alharthi
Study officials:
References: