Cerebral Palsy, SpasticNCT05251519
The Efficacy of Derotation Banding on Outcome Measures in Children With Cerebral Palsy
A study testing Kinesio Taping and Conventional Rehabilitation in people with Cerebral Palsy, Spastic, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to compare the conventional rehabilitation program and derotation taping applied with Kinesio Tex tape in addition to conventional rehabilitation in children with hemiplegic or monoplegic cerebral palsy with femoral internal rotation deformity. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Cerebral Palsy, Spastic
- What is being tested?
- Kinesio Taping and Conventional Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2022to 26 Aug 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with cerebral palsy aged 4-12 years with unilateral involvement who are hemiplegic or monoplegic
- Cases with Gross Motor Function Classification (GMFCS) level 1 or 2
- Understanding simple commands and signing the consent form
Who cannot join
- Presence of a static cause of femoral internal rotation deformity
- Situations that may prevent assessments or communication
- Lack of cooperation during work
- Presence of surgery that may affect assessments, such as joint freezing
- Presence of botulinum toxin administration in the last 6 months
- Development of an allergic reaction on the skin to the tape
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fethiye Private Son Atılım Special Education and Rehabilitation Center
Muğla, Fethiye, 48300
About this study
Official title: The Efficacy of Derotation Taping on Balance, Performance, Gait, Spasticity and Quality of Life in Femoral Internal Rotation Deformity in Children With Cerebral Palsy
The aim of the study is to compare the conventional rehabilitation program and derotation taping applied with Kinesio Tex tape in addition to conventional rehabilitation in children with hemiplegic or monoplegic cerebral palsy with femoral internal rotation deformity.
Read the detailed description
Conventional rehabilitation (CR) practices will be applied to the control group. Conventional rehabilitation (KT) application will be applied to the study group in addition to Kinesio Tex tape derotation banding. With the kinesio tape application, it is aimed to provide economical, ergonomic and effective support to the patients in non-clinical times. It is aimed to evaluate the patients' balance, quality of life, performance test, spasticity level and gait quality.
- Conditions
- Cerebral Palsy, Spastic
- Being tested
- Kinesio Taping, Conventional Rehabilitation
- Keywords
- Kinesio taping, Cerebral palsy
- 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
Derotation taping with Kinesio Tex is applied to the patients through a pediatric physiotherapist.
Conventional RehabilitationOther
Conventional rehabilitation program is applied to the patients through a pediatric physiotherapist
| Study group | Role | What they receive |
|---|---|---|
| Kinesio Taping Group (KTG) | Experimental | Conventional rehabilitation application will be performed in addition to Kinesio Tex tape derotation taping. Receives: Other: Kinesio Taping |
| Conventional Rehabilitation Group (CRG) | Active comparator | A conventional rehabilitation program will be applied to the patients through a pediatric physiotherapist. Receives: Other: Conventional Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
6MWT
The 6-meter course was mapped as 10 meters in length with a 2-meter acceleration interval and a 6-meter testing interval. There is no scoring range for the 6MWT.
Measured: Change from Baseline 6MWT at 3 days
PBBT
PBBT is a 14-item, criterion-referenced measure and examines functional balance in the context of everyday tasks. PBBT is scored between 0 to 56. Higher scores indicate better function.
Measured: Change from Baseline PBBT at 3 days
MAS
The Modified Ashworth Scale is a 6-point rating scale for gauging muscle resistance to passive movement. MAS is scored from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity.
Measured: Change from Baseline MAS at 3 days
EVGS
EVGS was developed to evaluate gait in children with CP using video recordings. It includes 17 variables, and each of these variables can be scored as 0, 1, or 2 based on movement deviation from normal. enced measure and examines functional balance in the context of everyday tasks. EVGS is scored between 0 to 34. Higher scores indicate worse gait function.
Measured: Change from Baseline EVGS at 3 days
KINDL
The KINDL was derived from a conceptual model, in which the four main components of quality of life, namely psychological well-being, social relationships, physical function and everyday life activities, were included in interviews with children. KINDL is scored between 0 to 100. Higher scores indicate better quality of life.
Measured: Change from Baseline KINDL at 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start15 Mar 2022
- Primary completion15 Aug 2022
- Study completion26 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy, SpasticStudies 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
- Randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Ozden, Muğla Sıtkı Koçman University
- Investigators
- Ahmet İmerci, PhD, Principal investigator, Muğla Sıtkı Koçman Universityİsmet Tümtürk, BSc, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251519
- Sponsor's protocol ID
- CPKT1
- Status last verified
- Aug 2022
- First submitted
- 31 Jan 2022
- Last updated
- 31 Aug 2022
- 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 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Derotation Taping on Balance, Performance, Gait, Spasticity and Quality of Life in Femoral Internal Rotation Deformity in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05251519
- Acronym / sponsor ID
- CPKT1
- Conditions
- Cerebral Palsy, Spastic
- Keywords
- Kinesio taping, Cerebral palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 26 Aug 2022 (actual)
- First posted
- 22 Feb 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.
The aim of the study is to compare the conventional rehabilitation program and derotation taping applied with Kinesio Tex tape in addition to conventional rehabilitation in children with hemiplegic or monoplegic cerebral palsy with femoral internal rotation deformity.
Detailed description
Conventional rehabilitation (CR) practices will be applied to the control group. Conventional rehabilitation (KT) application will be applied to the study group in addition to Kinesio Tex tape derotation banding. With the kinesio tape application, it is aimed to provide economical, ergonomic and effective support to the patients in non-clinical times. It is aimed to evaluate the patients' balance, quality of life, performance test, spasticity level and gait quality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Kinesio Taping Group (KTG) | Experimental | Other: Kinesio TapingConventional rehabilitation application will be performed in addition to Kinesio Tex tape derotation taping. |
| Conventional Rehabilitation Group (CRG) | Active comparator | Other: Conventional RehabilitationA conventional rehabilitation program will be applied to the patients through a pediatric physiotherapist. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children with cerebral palsy aged 4-12 years with unilateral involvement who are hemiplegic or monoplegic
- Cases with Gross Motor Function Classification (GMFCS) level 1 or 2
- Understanding simple commands and signing the consent form
Key exclusion criteria (6 listed)
- Presence of a static cause of femoral internal rotation deformity
- Situations that may prevent assessments or communication
- Lack of cooperation during work
- Presence of surgery that may affect assessments, such as joint freezing
- Presence of botulinum toxin administration in the last 6 months
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 TapingDerotation taping with Kinesio Tex is applied to the patients through a pediatric physiotherapist. | Other | Kinesio Taping Group (KTG) |
| Conventional RehabilitationConventional rehabilitation program is applied to the patients through a pediatric physiotherapist | Other | Conventional Rehabilitation Group (CRG) |
Primary outcome
6MWT
Time frame: Change from Baseline 6MWT at 3 days
The 6-meter course was mapped as 10 meters in length with a 2-meter acceleration interval and a 6-meter testing interval. There is no scoring range for the 6MWT.
PBBT
Time frame: Change from Baseline PBBT at 3 days
PBBT is a 14-item, criterion-referenced measure and examines functional balance in the context of everyday tasks. PBBT is scored between 0 to 56. Higher scores indicate better function.
MAS
Time frame: Change from Baseline MAS at 3 days
The Modified Ashworth Scale is a 6-point rating scale for gauging muscle resistance to passive movement. MAS is scored from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity.
EVGS
Time frame: Change from Baseline EVGS at 3 days
EVGS was developed to evaluate gait in children with CP using video recordings. It includes 17 variables, and each of these variables can be scored as 0, 1, or 2 based on movement deviation from normal. enced measure and examines functional balance in the context of everyday tasks. EVGS is scored between 0 to 34. Higher scores indicate worse gait function.
KINDL
Time frame: Change from Baseline KINDL at 3 days
The KINDL was derived from a conceptual model, in which the four main components of quality of life, namely psychological well-being, social relationships, physical function and everyday life activities, were included in interviews with children. KINDL is scored between 0 to 100. Higher scores indicate better quality of life.
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 31 Aug 2022.
- 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.
Ahmet İmerci, PhD principal investigator
Muğla Sıtkı Koçman University
İsmet Tümtürk, BSc principal investigator
Ege 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 Conventional Rehabilitation in people with Cerebral Palsy, Spastic, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
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 3 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 31 Aug 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 Turkey (Türkiye). 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?
6MWT (time frame: Change from Baseline 6MWT at 3 days). The study lists 5 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 31 Aug 2022.