MedTrace Logo

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

NCT05352607 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2022-04-29

No results posted yet for this study

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).

Conditions

  • Cerebral Palsy

Interventions

DEVICE

Transcutaneous Electrical Nerve Stimulation (TENS)

Put the patient in comfort position as long sitting on bed with a supported back and a pillow under the forearm, clean the skin by alcohol swab, setup the parameter, put a gel on electrodes then placed the negative electrode (black wire) over biceps belly and positive electrode (red wire) 3 cm distally from negative electrode , turn on TENS device . With increase the intensity gradually until patient feel a tingling sensation (no muscle contraction) and every 10 minutes ask patient about the feeling until complete 30 minutes.

OTHER

Conventional physiotherapy treatment

Application of a hot pack for 20 minutes to enhance muscle flexibility and get overall spastic muscle relaxation. Anti-spastic muscles (elbow extensors) facilitation: tapping followed by movements (three sets of 15 repetitions per session). Hand weight-bearing with bodyweight (two 5-minute per session). Passive stretching of tight muscles (elbow flexors) is used (this must be a slow and gradual stretch for 20 seconds, followed by 20 seconds of rest, five times per session). Upper-limb active exercises should be done gradually. include (finger flexion and extension exercises, elbow and shoulder (three sets of 20 reps for each session).

Sponsors & Collaborators

  • Reem Alharthi

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2022-02-09
Completion
2022-04-03

Countries

  • Saudi Arabia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05352607 on ClinicalTrials.gov