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

NCT05352607 | Completed

• 1 other identifier: HAPO-02-K-012-2022-01-912
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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).

Conditions

Cerebral Palsy

Keywords

Cerebral palsy; Adult; Spasticity; Transcutaneous electrical nerve stimulation; TENS; Conventional therapy

Outcome Measures

Primary Outcomes (2)

• Modified Ashworth Scale (MAS) to assess the muscle spasticity changes

  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 ).

  Pre intervention ( at baseline) , post 2 weeks and post 4 weeks

• Digital goniometer to assess the elbow range of motion changes

  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.

  Pre intervention( at baseline), post 2 weeks and post 4 weeks

Secondary Outcomes (1)

• Barthel Index to assess the activity of daily living changes

  Pre intervention ( at baseline) , post 2 weeks and post 4 weeks

Study Arms (2)

TENS group

EXPERIMENTAL

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).

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Control group

ACTIVE COMPARATOR

The Control group will receive the conventional physiotherapy treatment for upper limb spasticity only.

Other: Conventional physiotherapy treatment

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS) DEVICE

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.

TENS group

Conventional physiotherapy treatment OTHER

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).

Control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Reem Alharthi: lead

Study Sites (1)

Reem Alharthi

Ta'if, 26513, Saudi Arabia

Location

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physiotherapist

Model Details: 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.

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 29, 2022
• Study Start: February 1, 2022
• Primary Completion: February 9, 2022
• Study Completion: April 3, 2022
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

SA (1)