Cerebral PalsyNCT06326164
Effect of Kinesio-taping of Lower Limbs
A study testing kinesio-taping. and A designed physiotherapy program. in people with Cerebral Palsy, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The goal of this clinical trail is to test if kinesio-taping on lower limbs has an effect on balance and gait in children with diplegic cerebral palsy. Children in study group will have designed physiotherapy for gait and balance, the control group will have designed physiotherapy in addition to kinesio-taping on both… Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- kinesio-taping. and A designed physiotherapy program.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2024to 18 Jul 2024
- 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 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- A medical diagnosis of spastic diplegic cerebral palsy made by pediatricians or pediatric neurologists.
- Children with spasticity grades ranged from 1 to 1 plus according to Modified ashworth scale.
- Their age range from 6 to 10 years.
- Children who can stand with poor balance and recognize and follow verbal orders and commands included in both testing and training techniques
- No orthopedic surgeries
Who cannot join
- Children who have skin sensitivity for using kinesio-taping.
- A history of cardiac or orthopedic disability.
- Children having visual or auditory defects.
- They had a permanent deformity.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Asmaa Mohamed Khalil Sedeek
Kafr ash Shaykh
asmaa M khalil, 01101011588, asmaakhalil011010@gmail.com
About this study
Official title: Effect of Kinesio-taping of Lower Limbs on Gait and Balance in Children With Diplegic Cerebral Palsy
The goal of this clinical trail is to test if kinesio-taping on lower limbs has an effect on balance and gait in children with diplegic cerebral palsy. Children in study group will have designed physiotherapy for gait and balance, the control group will have designed physiotherapy in addition to kinesio-taping on both lower limbs.
Read the detailed description
Diplegic cerebral palsy is the most prevalent type of cerebral palsy. The main challenge for spastic cerebral palsy is gross motor dysfunction. The motor problems of spastic cerebral palsy arise fundamentally from central nervous system dysfunction, which interferes in the development of normal alignment postural control against gravity and impedes normal motor development.
Positive effects of kinesio taping for improving range of motion in patients with different disorders are reported in some of the studies. In the present study, kinesio taping along with physiotherapy treatment is considered an effective method for postural control improvement in diplegic cerebral palsy children.
Given the importance of motion and functional mobility in daily life, design and execution of accurate scientific interventions is necessary for health care systems economically and ethically.
Research on this field and accurate analysis of functional mobility, spasticity, and range of motion are rare. The main goal of physical therapy in the rehabilitation of cerebral palsy is to improve motor function and increase the ability to control movement. therefore, the present study aims to explore the effects of kinesio taping of lower limbs on gait and balance of children with spastic diplegic cerebral palsy.
- Conditions
- Cerebral Palsy
- Being tested
- kinesio-taping., A designed physiotherapy program.
- Keywords
- cerebral palsy- Diplegia- Kinesio-taping- Balance- Gait
- 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-taping.Procedure or surgery
A therapeutic tape that's applied strategically to the body to provide support, reduce pain, swelling and improve performance. Kinesio taping will be applied on both lower limbs. Taping will be applied for 4 days, 24 hours a day, on the lower limbs, and it will be removed for only one day per week.
A designed physiotherapy program.Procedure or surgery
The designed physiotherapy program included passive stretching, weight bearing, muscle strengthening, functional exercises, neurodevelopmental treatment, splinting, balance training, and gait training. The treatment protocol will be repeated each session per weeks for twelve weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Control group. Receives: Procedure: kinesio-taping. |
| Group B | Active comparator | Experimental group. Receives: Procedure: kinesio-taping.; Procedure: A designed physiotherapy program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gait.
Measurement of gait using Kinovea software.
Measured: Change from Baseline gait at twelve weeks.
Change in balance.
Measurement of balance using the Biodex balance system.
Measured: Change from Baseline balance at twelve weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start15 Feb 2024
- Primary completion15 Jun 2024 (estimated)
- Study completion18 Jul 2024 (estimated)
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 Kafrelsheikh 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Mohamed Khalil Sadeek, Kafrelsheikh University
- Investigators
- A M KH, Bachelor's, Principal investigator, Faculty of Physical Therapy Kafrelsheikh UniversityM B I, Ass. Prof, Study chair, Faculty of physical therapy Kafrelsheikh universityO A AE, Professor, Study chair, Faculty of medicine Kafrelshiekh universityS Y AE, lecturer, Study director, Faculty of physical therapy Kafrelshiekh university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326164
- Sponsor's protocol ID
- sample
- Status last verified
- Mar 2024
- First submitted
- 29 Feb 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kinesio-taping of Lower Limbs on Gait and Balance in Children With Diplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06326164
- Acronym / sponsor ID
- sample
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy- Diplegia- Kinesio-taping- Balance- Gait
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 18 Jul 2024 (estimated)
- First posted
- 22 Mar 2024 (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.
The goal of this clinical trail is to test if kinesio-taping on lower limbs has an effect on balance and gait in children with diplegic cerebral palsy. Children in study group will have designed physiotherapy for gait and balance, the control group will have designed physiotherapy in addition to kinesio-taping on both lower limbs.
Detailed description
Diplegic cerebral palsy is the most prevalent type of cerebral palsy. The main challenge for spastic cerebral palsy is gross motor dysfunction. The motor problems of spastic cerebral palsy arise fundamentally from central nervous system dysfunction, which interferes in the development of normal alignment postural control against gravity and impedes normal motor development.
Positive effects of kinesio taping for improving range of motion in patients with different disorders are reported in some of the studies. In the present study, kinesio taping along with physiotherapy treatment is considered an effective method for postural control improvement in diplegic cerebral palsy children.
Given the importance of motion and functional mobility in daily life, design and execution of accurate scientific interventions is necessary for health care systems economically and ethically.
Research on this field and accurate analysis of functional mobility, spasticity, and range of motion are rare. The main goal of physical therapy in the rehabilitation of cerebral palsy is to improve motor function and increase the ability to control movement. therefore, the present study aims to explore the effects of kinesio taping of lower limbs on gait and balance of children with spastic diplegic cerebral palsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: kinesio-taping.Control group. |
| Group B | Active comparator | Procedure: kinesio-taping., Procedure: A designed physiotherapy program.Experimental group. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- A medical diagnosis of spastic diplegic cerebral palsy made by pediatricians or pediatric neurologists.
- Children with spasticity grades ranged from 1 to 1 plus according to Modified ashworth scale.
- Their age range from 6 to 10 years.
- Children who can stand with poor balance and recognize and follow verbal orders and commands included in both testing and training techniques
- No orthopedic surgeries
Key exclusion criteria (4 listed)
- Children who have skin sensitivity for using kinesio-taping.
- A history of cardiac or orthopedic disability.
- Children having visual or auditory defects.
- They had a permanent deformity.
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-taping.A therapeutic tape that's applied strategically to the body to provide support, reduce pain, swelling and improve performance. Kinesio taping will be applied on both lower limbs. Taping will be applied for 4 days, 24 hours a day, on the lower limbs, and it will be removed for only one day per week. | Procedure or surgery | Group A, Group B |
| A designed physiotherapy program.The designed physiotherapy program included passive stretching, weight bearing, muscle strengthening, functional exercises, neurodevelopmental treatment, splinting, balance training, and gait training. The treatment protocol will be repeated each session per weeks for twelve weeks. | Procedure or surgery | Group B |
Primary outcome
Change in gait.
Time frame: Change from Baseline gait at twelve weeks.
Measurement of gait using Kinovea software.
Change in balance.
Time frame: Change from Baseline balance at twelve weeks.
Measurement of balance using the Biodex balance system.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
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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.
A M KH, Bachelor's principal investigator
Faculty of Physical Therapy Kafrelsheikh University
M B I, Ass. Prof study chair
Faculty of physical therapy Kafrelsheikh university
O A AE, Professor study chair
Faculty of medicine Kafrelshiekh 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. and A designed physiotherapy program. in people with Cerebral Palsy, run by Kafrelsheikh 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 4 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 22 Mar 2024. 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 A M KH, Bachelor's (01101011588, asmaakhalil011010@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gait. (time frame: Change from Baseline gait at twelve 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 22 Mar 2024.