Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Spasticity in Adult Patients With Spastic Cerebral Palsy

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Device: Transcutaneous Electrical Nerve Stimulation (TENS); Other: Conventional physiotherapy treatment

• Registration Number: NCT05352607
• Lead Sponsor: Reem Alharthi

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-01
• Primary Completion: 2022-02-09
• Status Verified: 2022-04
• Study Completion: 2022-04-03
• Study First Submitted: 2022-04-11
• Study First Submitted QC: 2022-04-23
• Last Update Submitted: 2022-04-23
• Study First Posted: 2022-04-29
• Last Update Posted: 2022-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TENS group	Transcutaneous Electrical Nerve Stimulation (TENS)	TENS group will receive the conventional physiotherapy treatment plus TENS. TENS is most commonly used directly on affected muscles in patients with CP. The device will be used from Cosmogamma company (MIXING 2 (EVO): COMBINED THERAPY). It consists of 3 parts: the stimulator part, electrode and connected wires. Strap or plaster for electrodes adhesive with gel. Electrode diameter (6×4.5 cm). The program will be (Pain therapy - TENS - Free program - Modify -Parameter's setup). Parameter setup (pulse frequency= 100 Hz, pulse duration= 250 μs, time=30 minutes and the intensity according to patient to feel tingling sensation only and no muscle contraction).
Control group	Conventional physiotherapy treatment	The Control group will receive the conventional physiotherapy treatment for upper limb spasticity only.

Primary Outcome Measures

Name	Time	Method
Modified Ashworth Scale (MAS) to assess the muscle spasticity changes	Pre intervention ( at baseline) , post 2 weeks and post 4 weeks	The modified Ashworth scale is the most widely used clinical instrument for determining muscle tone changes. In this study will measure the elbow flexor spasticity by 3 examiners (3 minutes rest in between), then will calculate the average. 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. According to inclusion criteria, patients with grades 2 or 3 will be enrolled , then after intervention may be this grade will be deceased ( spasticity decreased ).
Digital goniometer to assess the elbow range of motion changes	Pre intervention( at baseline), post 2 weeks and post 4 weeks	Digital goniometer is a valid tool for assessing joint range of motion. The digital goniometer has adequate concurrent criterion-related validity and comparable inter- and intra-rater reliability to the Universal goniometer. Three examiners will measure elbow joint range of motion (from full flexion to full extension), ( passively) 3 minutes rest in between.

Secondary Outcome Measures

Name	Time	Method
Barthel Index to assess the activity of daily living changes	Pre intervention ( at baseline) , post 2 weeks and post 4 weeks	The Barthel is a quick and accurate, reliable assessment of mobility and activity of daily living , that works in both skillful and unskilled hands. In this study, the investigators will choose the items related to upper limb function (feeding, bathing, grooming, dressing and toilet use) with total score 40 which indicating highest independence and 0 indicating highest dependence .

Trial Locations

Locations (1)

Reem Alharthi; 🇸🇦 Ta'if, Saudi Arabia