Cerebral Palsy, SpasticNCT05251532
The Efficacy of Distortion 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 the distortion taping applied with Kinesio Tex tape in addition to conventional rehabilitation in children with hemiplegic or monoplegic cerebral palsy with ankle varus 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 25 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 equinus 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 Distortion Taping on Balance, Performance, Gait, Spasticity and Quality of Life in Ankle Varus Deformity in Children With Cerebral Palsy
The aim of the study is to compare the conventional rehabilitation program and the distortion taping applied with Kinesio Tex tape in addition to conventional rehabilitation in children with hemiplegic or monoplegic cerebral palsy with ankle varus deformity.
Read the detailed description
Conventional rehabilitation practices will be applied to the control group. In addition to Kinesio Tex tape distortion taping, conventional rehabilitation will be applied to the intervention group. 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
- Cerebral palsy, 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
In addition to Kinesio Tex tape distortion taping, conventional rehabilitation is applied.
Conventional RehabilitationOther
Conventional rehabilitation practices are carried out
| Study group | Role | What they receive |
|---|---|---|
| Kinesio Taping Group (KTG) | Experimental | Distortion taping with Kinesio Tex will be applied to the patients in addition to conventional rehabilitation through a pediatric physiotherapist. Receives: Other: Kinesio Taping |
| Conventional Rehabilitation Group (CRG) | Active comparator | 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.
TUG
Patients are asked to get up from a standard chair, walk 3 meters at a safe and comfortable pace, and return without stopping to sit back in the chair safely. The elapsed time is calculated. There is no score range in TUG.
Measured: Change from Baseline TUG at 3 days
SLS
The one-leg standing test measures the time one is able to stand on one lower limb without support. There is no score range in SLS.
Measured: Change from Baseline SLS at 3 days
Modified Ashworth Scale (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
WGS
The scale allows for a multifactorial gait analysis, takes in to account 14 observable gait parameters divided into four sub-scales referring to particular phases of gait, i.e. stance phase, toe off, swing phase, andheel strike. WGS is scored from 13.35 to 42.0. Higher scores indicate higher impairment.
Measured: Change from Baseline WGS at 3 days
CHQ
The CHQ is a validated multidimensional instrument that measures the functional health and well-being of children and young people. CHQ is scored from 0 to 100. Higher scores indicate better health status.
Measured: Change from Baseline CHQ 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 completion25 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
- NCT05251532
- Sponsor's protocol ID
- CPKT2
- Status last verified
- Aug 2022
- First submitted
- 31 Jan 2022
- Last updated
- 1 Sep 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 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Distortion Taping on Balance, Performance, Gait, Spasticity and Quality of Life in Ankle Varus Deformity in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05251532
- Acronym / sponsor ID
- CPKT2
- Conditions
- Cerebral Palsy, Spastic
- Keywords
- Cerebral palsy, Kinesio taping
- 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
- 25 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 the distortion taping applied with Kinesio Tex tape in addition to conventional rehabilitation in children with hemiplegic or monoplegic cerebral palsy with ankle varus deformity.
Detailed description
Conventional rehabilitation practices will be applied to the control group. In addition to Kinesio Tex tape distortion taping, conventional rehabilitation will be applied to the intervention group. 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 TapingDistortion taping with Kinesio Tex will be applied to the patients in addition to conventional rehabilitation through a pediatric physiotherapist. |
| Conventional Rehabilitation Group (CRG) | Active comparator | Other: Conventional RehabilitationConventional 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 equinus 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 TapingIn addition to Kinesio Tex tape distortion taping, conventional rehabilitation is applied. | Other | Kinesio Taping Group (KTG) |
| Conventional RehabilitationConventional rehabilitation practices are carried out | Other | Conventional Rehabilitation Group (CRG) |
Primary outcome
TUG
Time frame: Change from Baseline TUG at 3 days
Patients are asked to get up from a standard chair, walk 3 meters at a safe and comfortable pace, and return without stopping to sit back in the chair safely. The elapsed time is calculated. There is no score range in TUG.
SLS
Time frame: Change from Baseline SLS at 3 days
The one-leg standing test measures the time one is able to stand on one lower limb without support. There is no score range in SLS.
Modified Ashworth Scale (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.
WGS
Time frame: Change from Baseline WGS at 3 days
The scale allows for a multifactorial gait analysis, takes in to account 14 observable gait parameters divided into four sub-scales referring to particular phases of gait, i.e. stance phase, toe off, swing phase, andheel strike. WGS is scored from 13.35 to 42.0. Higher scores indicate higher impairment.
CHQ
Time frame: Change from Baseline CHQ at 3 days
The CHQ is a validated multidimensional instrument that measures the functional health and well-being of children and young people. CHQ is scored from 0 to 100. Higher scores indicate better health status.
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 1 Sep 2022.
- Individual participant dataSharing planned: No
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Video-based Visual Feedback Combined With Task-oriented Physiotherapy Among Cerebral Palsy
Cerebral Palsy (CP)
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Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
Not yet recruitingObservational study
Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
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Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy
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 1 Sep 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?
TUG (time frame: Change from Baseline TUG 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 1 Sep 2022.