Cerebral PalsyNCT05352607
Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Spasticity in Adult Patients With Spastic Cerebral Palsy
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) and Conventional physiotherapy treatment in people with Cerebral Palsy, run by Reem Alharthi at 1 site in Saudi Arabia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation (TENS) and Conventional physiotherapy treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Feb 2022to 3 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Upper Limb Spasticity in Adult Patients With Spastic Cerebral Palsy: A Randomized Control Trial
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.
Read more
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
- Being tested
- Transcutaneous Electrical Nerve Stimulation (TENS), Conventional physiotherapy treatment
- Keywords
- Cerebral palsy, Adult, Spasticity, Transcutaneous electrical nerve stimulation, TENS, Conventional therapy
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 treatmentOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS) |
| Control group | Active comparator | The Control group will receive the conventional physiotherapy treatment for upper limb spasticity only. Receives: Other: Conventional physiotherapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 ).
Measured: 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.
Measured: Pre intervention( at baseline), post 2 weeks and post 4 weeks
Secondary outcomes (1)
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 .
Measured: Pre intervention ( at baseline) , post 2 weeks and post 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start1 Feb 2022
- Primary completion9 Feb 2022
- Study completion3 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reem Alharthi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Reem Alharthi, Umm Al-Qura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352607
- Sponsor's protocol ID
- HAPO-02-K-012-2022-01-912
- Status last verified
- Apr 2022
- First submitted
- 11 Apr 2022
- Last updated
- 29 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Upper Limb Spasticity in Adult Patients With Spastic Cerebral Palsy: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05352607
- Acronym / sponsor ID
- HAPO-02-K-012-2022-01-912
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, Adult, Spasticity, Transcutaneous electrical nerve stimulation, TENS, Conventional therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Reem AlharthiUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 9 Feb 2022 (actual)
- Study completion
- 3 Apr 2022 (actual)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| TENS group | Experimental | Device: Transcutaneous Electrical Nerve Stimulation (TENS)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). |
| Control group | Active comparator | Other: Conventional physiotherapy treatmentThe Control group will receive the conventional physiotherapy treatment for upper limb spasticity only. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- Patient with epilepsy
- Under antispastic medication
- Severe psychological or behavioral problem
- Sensory abnormalities
- Orthopedic surgery or severe deformities in upper limb
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | TENS group |
| Conventional physiotherapy treatmentApplication 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). | Other | Control group |
Primary outcome
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 ).
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.
1 secondary outcome
Barthel Index to assess the activity of daily living changes
Time frame: Pre intervention ( at baseline) , post 2 weeks and post 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) and Conventional physiotherapy treatment in people with Cerebral Palsy, run by Reem Alharthi at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ashworth Scale (MAS) to assess the muscle spasticity changes (time frame: Pre intervention ( at baseline) , post 2 weeks and post 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.