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NCT Number: NCT05352607

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

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).

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Reem Alharthi

Ta'if, 26513, Saudi Arabia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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).

Primary outcomes

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

    Time frame: 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 ).

  2. Digital goniometer to assess the elbow range of motion changes

    Time frame: 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 outcomes

  1. Barthel Index to assess the activity of daily living changes

    Time frame: 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 .

Sponsors and collaborators

Lead sponsor

Reem Alharthi

Other

Registry information

Official study title

Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Upper Limb Spasticity in Adult Patients With Spastic Cerebral Palsy: A Randomized Control Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 29, 2022
Registry last updated
Apr 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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