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

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Transcutaneous Electrical Nerve Stimulation (TENS)
Conventional physiotherapy treatment
Sponsored by
Reem Alharthi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral palsy, Adult, Spasticity, Transcutaneous electrical nerve stimulation, TENS, Conventional therapy

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Reem Alharthi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TENS group

Control group

Arm Description

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).

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

Outcomes

Primary Outcome Measures

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 ).
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.

Secondary Outcome Measures

Barthel Index to assess the activity of daily living changes
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 .

Full Information

First Posted
April 11, 2022
Last Updated
April 23, 2022
Sponsor
Reem Alharthi
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1. Study Identification

Unique Protocol Identification Number
NCT05352607
Brief Title
Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Spasticity in Adult Patients With Spastic Cerebral Palsy
Official Title
Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Upper Limb Spasticity in Adult Patients With Spastic Cerebral Palsy: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
February 9, 2022 (Actual)
Study Completion Date
April 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Reem Alharthi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Cerebral palsy, Adult, Spasticity, Transcutaneous electrical nerve stimulation, TENS, Conventional therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TENS group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The Control group will receive the conventional physiotherapy treatment for upper limb spasticity only.
Intervention Type
Device
Intervention Name(s)
Transcutaneous Electrical Nerve Stimulation (TENS)
Intervention Description
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
Other
Intervention Name(s)
Conventional physiotherapy treatment
Intervention Description
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 Outcome Measure Information:
Title
Modified Ashworth Scale (MAS) to assess the muscle spasticity changes
Description
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 ).
Time Frame
Pre intervention ( at baseline) , post 2 weeks and post 4 weeks
Title
Digital goniometer to assess the elbow range of motion changes
Description
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.
Time Frame
Pre intervention( at baseline), post 2 weeks and post 4 weeks
Secondary Outcome Measure Information:
Title
Barthel Index to assess the activity of daily living changes
Description
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 .
Time Frame
Pre intervention ( at baseline) , post 2 weeks and post 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Reem Alharthi
City
Ta'if
ZIP/Postal Code
26513
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Yes

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

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