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

NCT ID: NCT05352607

Last Updated: 2022-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2022-04-03

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TENS group

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).

Group Type: EXPERIMENTAL

Transcutaneous Electrical Nerve Stimulation (TENS)

Intervention Type: 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.

Control group

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

Group Type: ACTIVE_COMPARATOR

Conventional physiotherapy treatment

Intervention Type: 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).

Interventions

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.

Intervention Type: DEVICE

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).

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Reem Alharthi

OTHER

Sponsor Role: lead

Responsible Party

Reem Alharthi

Physiotherapist

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Reem Alharthi

Ta'if, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

HAPO-02-K-012-2022-01-912

Identifier Type: -

Identifier Source: org_study_id