Cerebral PalsyNCT04243928
Role of Kinesiotape Over Dorsi Flexors Muscles on Balance in Children With Spastic Diplegia
A study testing kinesio taping in people with Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
To detect the effect of kinesio -tape on balance in children with spastic diplegia. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- kinesio taping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Feb 2019to 13 Oct 2019
- 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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • Thirty children with spastic diplegia of both genders participated in this study.
- Theywere selected from the out-patient clinic, faculty of physical therapy, Cairo University.
- Children height not less than 1 meter to be able to see the screen of the biodex balance system.
- Their agehad ranged from 4 to 8 years.
- All patients have mild spasticity according to modified Aschwar scale grade 1 \&1+ (Alhusaini, 2010) presented in (Appendix I).
- All patients wereable to stand alone GMFM presented in (Appendix II).
- They could understand and follow instructions.
- All Children used Ankle Foot Orthosis.
Who cannot join
- • Children with visual or auditory problems.
- Children with positive sensitivity to kinesiotape.
- Children with irrivisable muscle contracture at the calf muscles.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Kinesiotape Over Dorsi Flexors Muscles on Balance in Children With Spastic Diplegia (Using Biodex Balance System)
To detect the effect of kinesio -tape on balance in children with spastic diplegia.
Read the detailed description
The use of Kinesio Taping might influence the cutaneous receptors of the sensory motor system, resulting in the improvement of voluntary control and coordination in a physiotherapy program for children with CP. (Yasukawa et al., 2006).
The study will be conducted To investigate the effect of kinesiotape applied on dorsi fexors muscles on improving balance in spastic diplegic children .
- Conditions
- Cerebral Palsy
- Being tested
- kinesio taping
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kinesio tapingOther
apply kinesio taping on dorsi flexors muscles
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | 15 diplegic children received regular exercise program including balance exercise Receives: Other: kinesio taping |
| study group | Experimental | 15 diplegic children recieved regular exercise program plus putting kinesiotape Receives: Other: kinesio taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of K-Tape on balance
effect of using K-Tape on dorsi flexors to see its effect on balance
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start10 Feb 2019
- Primary completion11 Aug 2019
- Study completion13 Oct 2019
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- children rranged from 4 years uo to 10 years with Spastic diplegia
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Samy Ibrahim Hegazy, Cairo University
- Investigators
- I, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243928
- Sponsor's protocol ID
- peadiatrics 123
- Status last verified
- Dec 2017
- First submitted
- 22 Jan 2020
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Kinesiotape Over Dorsi Flexors Muscles on Balance in Children With Spastic Diplegia (Using Biodex Balance System)
- ClinicalTrials.gov ID
- NCT04243928
- Acronym / sponsor ID
- peadiatrics 123
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Feb 2019 (actual)
- Primary completion
- 11 Aug 2019 (actual)
- Study completion
- 13 Oct 2019 (actual)
- First posted
- 28 Jan 2020 (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.
To detect the effect of kinesio -tape on balance in children with spastic diplegia.
Detailed description
The use of Kinesio Taping might influence the cutaneous receptors of the sensory motor system, resulting in the improvement of voluntary control and coordination in a physiotherapy program for children with CP. (Yasukawa et al., 2006).
The study will be conducted To investigate the effect of kinesiotape applied on dorsi fexors muscles on improving balance in spastic diplegic children .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- children rranged from 4 years uo to 10 years with Spastic diplegia
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: kinesio taping15 diplegic children received regular exercise program including balance exercise |
| study group | Experimental | Other: kinesio taping15 diplegic children recieved regular exercise program plus putting kinesiotape |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- • Thirty children with spastic diplegia of both genders participated in this study.
Key exclusion criteria (3 listed)
- • Children with visual or auditory problems.
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 |
|---|---|---|
| kinesio tapingapply kinesio taping on dorsi flexors muscles | Other | control group, study group |
Primary outcome
effect of K-Tape on balance
Time frame: three months
effect of using K-Tape on dorsi flexors to see its effect on balance
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 28 Jan 2020.
- Individual participant dataSharing planned: No
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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.
I principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing kinesio taping in people with 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 8 inclusion and 3 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 28 Jan 2020. 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?
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?
effect of K-Tape on balance (time frame: three months). 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 28 Jan 2020.