Cerebral PalsyNCT05649254
Effect of TENS in Children With Spastic Cerebral Palsy
An observational study of Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
TENS is cheap and simple tool for physiotherapist, free of many side effects compared with other tools. so The aim of study was record the effect of TENS on calf muscle tone in spastic cerebral palsy children. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Cerebral Palsy
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Nov 2022to Jun 2023
- Phase
- Observational
- 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 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: children diagnosed with spastic cerebral palsy diplgeia of both sexes will be selected from El-Menshawy public governmental hospital in Tanta City following the official rules and after gaining the agreements of the parents and explaining the aim and procedures of the study.
Who may be able to join
- The children will be included in this study is according to the following criteria
- Cerebral palsy spastic diaplegia.
- Their age ranged from 3-10 years.
- Both Sexes were included.
- The subjects with mild to moderate muscle tone according to MAS in which mild is 1 and 1+ , and moderate is 2.
Who cannot join
- The subject will be excluded if he/she has one or more of the following criteria:
- Children with a history of seizures.
- Children who could not lie prone for any cause.
- Children who could not react to pain.
- Children who had applied any surgical procedure which affect muscle tone or any inhibitory injections like BOTOX.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of physical therapy Cairo university
Giza, Dokki, 3387722
About this study
Official title: Immediate Effect of Transcutaneous Electrical Nerve Stimulation on Muscle Tone in Children With Spastic Cerebral Palsy
TENS is cheap and simple tool for physiotherapist, free of many side effects compared with other tools. so The aim of study was record the effect of TENS on calf muscle tone in spastic cerebral palsy children.
Read the detailed description
The Significance of this study is to determine whether TENS could have an immediate effect on reduction of spasticity in children diagnosed with spastic cerebral palsy by studying the change of spasticity of ankle plantarflexors immediately after applying TENS to the ankle dorsiflexors.
Muscle tone assessment will be applied before and after the application using objective tool which is electromyography and subjectively by using modified Ashworth scale and goniometer, to be insured is there is an immediate effect of TENS on muscle tone of calf muscle or not.
- Conditions
- Cerebral Palsy
- Keywords
- TENS
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| study group | in which TENS application will be applied | |
| Control group | placebo treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
MUSCLE TONE that will be measured subjectively by modified ashwoth scale
the study will assess if TENS have effect on muscle tone or not the tone will be measured subjectivly by using modified ashworth scale . The Modified Ashworth scale evaluation involves the rater manually moving a limb through the range of motion to passively stretch specific muscle groups and a six-point ordinal scale for grading the resistance encountered during such passive muscle stretching. 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start30 Nov 2022
- Primary completionMay 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amgad Elwy Ali Hussein, Cairo University
- Investigators
- Asmaa Osama Sayed, Phd, Study director, Assistant Professor at Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649254
- Sponsor's protocol ID
- TENS IN CP CHILDREN
- Status last verified
- Mar 2023
- First submitted
- 21 Nov 2022
- Last updated
- 4 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mills PB, Dossa F. Transcutaneous Electrical Nerve Stimulation for Management of Limb Spasticity: A Systematic Review. Am J Phys Med Rehabil. 2016 Apr;95(4):309-18. doi: 10.1097/PHM.0000000000000437.
PubMed 26829077Aydin G, Tomruk S, Keles I, Demir SO, Orkun S. Transcutaneous electrical nerve stimulation versus baclofen in spasticity: clinical and electrophysiologic comparison. Am J Phys Med Rehabil. 2005 Aug;84(8):584-92. doi: 10.1097/01.phm.0000171173.86312.69.
PubMed 16034227
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effect of Transcutaneous Electrical Nerve Stimulation on Muscle Tone in Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05649254
- Acronym / sponsor ID
- TENS IN CP CHILDREN
- Conditions
- Cerebral Palsy
- Keywords
- TENS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 14 Dec 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.
TENS is cheap and simple tool for physiotherapist, free of many side effects compared with other tools. so The aim of study was record the effect of TENS on calf muscle tone in spastic cerebral palsy children.
Detailed description
The Significance of this study is to determine whether TENS could have an immediate effect on reduction of spasticity in children diagnosed with spastic cerebral palsy by studying the change of spasticity of ankle plantarflexors immediately after applying TENS to the ankle dorsiflexors.
Muscle tone assessment will be applied before and after the application using objective tool which is electromyography and subjectively by using modified Ashworth scale and goniometer, to be insured is there is an immediate effect of TENS on muscle tone of calf muscle or not.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | –in which TENS application will be applied |
| Control group | – | –placebo treatment |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children diagnosed with spastic cerebral palsy diplgeia of both sexes will be selected from El-Menshawy public governmental hospital in Tanta City following the official rules and after gaining the agreements of the parents and explaining the aim and procedures of the study.
Key inclusion criteria (5 listed)
- The children will be included in this study is according to the following criteria
Key exclusion criteria (5 listed)
- The subject will be excluded if he/she has one or more of the following criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MUSCLE TONE that will be measured subjectively by modified ashwoth scale
Time frame: Baseline
the study will assess if TENS have effect on muscle tone or not the tone will be measured subjectivly by using modified ashworth scale . The Modified Ashworth scale evaluation involves the rater manually moving a limb through the range of motion to passively stretch specific muscle groups and a six-point ordinal scale for grading the resistance encountered during such passive muscle stretching. 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Background: PubMed 26829077Mills PB, Dossa F. Transcutaneous Electrical Nerve Stimulation for Management of Limb Spasticity: A Systematic Review. Am J Phys Med Rehabil. 2016 Apr;95(4):309-18. doi: 10.1097/PHM.0000000000000437.
- Results publication: PubMed 16034227Aydin G, Tomruk S, Keles I, Demir SO, Orkun S. Transcutaneous electrical nerve stimulation versus baclofen in spasticity: clinical and electrophysiologic comparison. Am J Phys Med Rehabil. 2005 Aug;84(8):584-92. doi: 10.1097/01.phm.0000171173.86312.69.
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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.
Asmaa Osama Sayed, Phd study director
Assistant Professor at Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by Cairo University at 1 site in Egypt.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 4 Apr 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amgad Elwy Hussein, Bachelor (00201100516508, amgad.elwy.hussein@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MUSCLE TONE that will be measured subjectively by modified ashwoth scale (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05649254, which also lists 2 linked publications.
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 4 Apr 2023.