BalanceNCT03541070
The Effect of Kinesiology Taping on Balance in Duchenne Muscular Dystrophy
A study testing Kinesiology tape in people with Balance and Duchenne Muscular Dystrophy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Investigators investigated that the effects of kinesilogy taping on balance in patients with Duchenne Muscular Dystrophy Read more about this study
- Who is it for?
- Ages 5 to 14 years, men only
- Conditions the study is for
- Balance, Duchenne Muscular Dystrophy
- What is being tested?
- Kinesiology tape
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2017to 10 Nov 2017
- 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 5 to 14 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- DMD diagnosis being Level I and II according to Brooke Lower Extremity Functional Classification no cooperation problem no injury or orthopedic/neurologic surgery within the past 6 months no severe contracture at ankle
Who cannot join
- children who did not meet the above criteria were not included
Trial locations and contacts
1 site in 1 country.
About this study
Investigators investigated that the effects of kinesilogy taping on balance in patients with Duchenne Muscular Dystrophy
Read the detailed description
Forty-five patients from Level 1 and 2 according to the Brooke Lower Extremity Functional Classification were included in the study. Balance was assessed by Pediatric Berg Balance Test (PBBT), Timed and Go Test (TUGT), and standing on one leg test. Kinesiology taping (KT) with facilitation technique was applied on bilateral quadriceps and tibialis anterior muscles and the assessments were repeated 1 hour after application. The comparison between before and after taping was analyzed.
- Conditions
- Balance, Duchenne Muscular Dystrophy
- Being tested
- Kinesiology tape
- Keywords
- kinesiology taping, balance, Duchenne Muscular Dystrophy
- Medical subject headings
- Muscular Dystrophy, Duchenne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesiology tapeDevice
Kinesiology taping (KT) was developed by Kenzo Kase in the 1970s. KT has similar thickness and flexibility to the skin. These tapes are used in orthopedic and sports injuries as well as neurological and rheumatic diseases, pediatric patients, lymph edema and painful conditions. These tapes are used for correcting muscle function, increasing circulation, increasing proprioception, reducing pain, and repositioning the sublease joint according to the usage method
| Study group | Role | What they receive |
|---|---|---|
| Kinesiology taping | Experimental | For tibialis anterior muscle taping, each children's feet were placed at plantar flexion and eversion position while knees were extended, and I-shaped band was applied over tibialis anterior from origin to insertion of muscle with approximately 25-50% tension of the original length of the band. No tension was applied to the first and last 5 cm section of the bands in both applications because it were used as anchor. The tapes were remained for 1 hour on skin of both quadriceps and tibialis anterior muscles, and in this time the children were rested. Receives: Device: Kinesiology tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance Test-Timed up and go test
Timed up and go test is a valid and practical objective measure for the pediatric population that measuring various components such as walking speed, postural control, functional mobility and balance. The children were asked to stand up from a chair, walk during 3 meters, turn, and walk back to chair and sit down. This time was recorded as second
Measured: About 15 seconds
Secondary outcomes (2)
Pediatric Berg Balance Test
Pediatric Berg Balance Test is a modified version of the Berg Balance Scale that a valid and reliable test for the elderly population, for children in school age with mild to moderate motor impairment. The patients were asked to maintain their balance at the positions indicated in the test. The score of each item varies according to the parameters of the test. The score of this test is between 0-4 and the highest total score is 56.
Measured: 15 minutes
duration in standing on one leg
Duration in standing on right and left leg was recorded as second
Measured: about 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start10 Jun 2017
- Primary completion15 Sep 2017
- Study completion10 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BalanceStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Güllü AYDIN, Hacettepe University
- Investigators
- Güllü Aydın, R.A, Principal investigator, Hacettepe Universityİpek Alemdaroğlu Gürbüz, Assoc. Prof., Principal investigator, Hacettepe UniversityÖznur Yılmaz, Prof., Principal investigator, Hacettepe UniversityAyşe Karaduman, Prof., Principal investigator, Hacettepe UniversityNuman Bulut, R.A, Principal investigator, Hacettepe UniversityHaluk Topaloğlu, Prof., Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541070
- Sponsor's protocol ID
- KA-17070-1
- Status last verified
- May 2018
- First submitted
- 15 May 2018
- Last updated
- 30 May 2018
- 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 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Kinesiology Taping on Balance in Duchenne Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT03541070
- Acronym / sponsor ID
- KA-17070-1
- Conditions
- Balance, Duchenne Muscular Dystrophy
- Keywords
- kinesiology taping, balance, Duchenne Muscular Dystrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 10 Jun 2017 (actual)
- Primary completion
- 15 Sep 2017 (actual)
- Study completion
- 10 Nov 2017 (actual)
- First posted
- 30 May 2018 (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.
Investigators investigated that the effects of kinesilogy taping on balance in patients with Duchenne Muscular Dystrophy
Detailed description
Forty-five patients from Level 1 and 2 according to the Brooke Lower Extremity Functional Classification were included in the study. Balance was assessed by Pediatric Berg Balance Test (PBBT), Timed and Go Test (TUGT), and standing on one leg test. Kinesiology taping (KT) with facilitation technique was applied on bilateral quadriceps and tibialis anterior muscles and the assessments were repeated 1 hour after application. The comparison between before and after taping was analyzed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kinesiology taping | Experimental | Device: Kinesiology tapeFor tibialis anterior muscle taping, each children's feet were placed at plantar flexion and eversion position while knees were extended, and I-shaped band was applied over tibialis anterior from origin to insertion of muscle with approximately 25-50% tension of the original length of the band. No tension was applied to the first and last 5 cm section of the bands in both applications because it were used as anchor. The tapes were remained for 1 hour on skin of both quadriceps and tibialis anterior muscles, and in this time the children were rested. |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- DMD diagnosis being Level I and II according to Brooke Lower Extremity Functional Classification no cooperation problem no injury or orthopedic/neurologic surgery within the past 6 months no severe contracture at ankle
Key exclusion criteria (1 listed)
- children who did not meet the above criteria were not included
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 |
|---|---|---|
| Kinesiology tapeKinesiology taping (KT) was developed by Kenzo Kase in the 1970s. KT has similar thickness and flexibility to the skin. These tapes are used in orthopedic and sports injuries as well as neurological and rheumatic diseases, pediatric patients, lymph edema and painful conditions. These tapes are used for correcting muscle function, increasing circulation, increasing proprioception, reducing pain, and repositioning the sublease joint according to the usage method | Device | Kinesiology taping |
Primary outcome
Balance Test-Timed up and go test
Time frame: About 15 seconds
Timed up and go test is a valid and practical objective measure for the pediatric population that measuring various components such as walking speed, postural control, functional mobility and balance. The children were asked to stand up from a chair, walk during 3 meters, turn, and walk back to chair and sit down. This time was recorded as second
2 secondary outcomes
Pediatric Berg Balance Test
Time frame: 15 minutes
duration in standing on one leg
Time frame: about 1 minute
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 30 May 2018.
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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.
Güllü Aydın, R.A principal investigator
Hacettepe University
İpek Alemdaroğlu Gürbüz, Assoc. Prof. principal investigator
Hacettepe University
Öznur Yılmaz, Prof. principal investigator
Hacettepe 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 Kinesiology tape in people with Balance and Duchenne Muscular Dystrophy, run by Hacettepe 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 1 inclusion and 1 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 30 May 2018. 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?
Balance Test-Timed up and go test (time frame: About 15 seconds). 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 30 May 2018.