PerformanceNCT03529240
Kinesiology Taping in Duchenne Muscular Dystrophy: Effects on Performance, Gait Characteristics, and Energy Consumption
A study testing Kinesiology Taping in people with Performance and Energy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Investigators investigated that the effects of kinesilogy taping on performance, energy consumption and gait characteristics 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
- Performance, Energy, Gait
- What is being tested?
- Kinesiology Taping
- 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 5 Oct 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
- Duchenne Muscular Dystrophy diagnosis,
- age 5 to 14 years,
- able to cooperate with instructions of physiotherapist,
- able to walk independently,
- climb 4 steps independently/with minimal support from handrails.
Who cannot join
- severe contracture at lower extremities,
- other disease except for DMD, and
- history of any injury or orthopaedic/neurologic surgery within the past 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Investigators investigated that the effects of kinesilogy taping on performance, energy consumption and gait characteristics 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. Performance was assessed by measuring the distance in 6-minute walk test (6MWT) and the duration of timed performance tests; energy consumption by Physiological Consumption Index (PCI), and gait characteristics by footprint method on powdered ground at baseline. Kinesiology taping 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
- Performance, Energy, Gait, Duchenne Muscular Dystrophy
- Being tested
- Kinesiology Taping
- Keywords
- kinesiology taping, performance, energy consumption, gait, 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 TapingDevice
Kinesiology taping (KT) which was developed by Dr. Kenzo Kase, is a new application of elastic and adhesive taping. KT is applied by specialized physiotherapists and physicians. This type of taping is a very frequently used technique to accelerate recovery after musculoskeletal injuries. Also, this technique is usually used as an alternative to athletic taping to support fascias, muscles, and joints for many purpose such as positioning, inhibition, and fascilitation
| Study group | Role | What they receive |
|---|---|---|
| Kinesiology taping | Experimental | After performing the baseline assessments, kinesiology taping with facilitation technique was applied on bilateral quadriceps and tibialis anterior muscles of children. In both applications, the first and last 5 cm section of the bands were used as anchor and no tension was applied. Receives: Device: Kinesiology Taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six Minute Walk Test
Six Minute Walk Test was used commonly in DMD were found to be valid, reliable and easy to apply in the clinic. Children were asked to walk during 6 minutes as fast as they can at a corridor specified by two cones and walking distances were recorded as meter (m) for 6MWT. The time passed during timed performance tests were recorded as seconds.
Measured: 6 minute
Secondary outcomes (3)
Energy Consumption
Physiologic Consumption Index (PCI) was used to evaluate energy consumption of children during 6MWT. energy consumption was calculated by using the formula of PCI (walking heart rate)-(resting heart rate)/(walking speed)
Measured: 6 minutes
Gait
Gait analysis of the children was performed by footprint method on 10-meters powdered floor. First and last 2 meters of this floor were dissociated from the assessment, and both the right and left stride lengths, both right and left foot angles, and stride width were analyzed in the middle 6-meter section.. Stride length was measured by measuring the distance between right and left midpoint heels. Double stride length was sum of right and left stride length. Stride width was measured by horizontal distance between heel midpoints. Foot angles were measured by a goniometer considering the line between the first and second metatarsal heads and the heel midpoints of both feet separately 24. The number of steps during 6MWT was also calculated by pedometer (Omron, Walking style One 2.0 HJ-320-E) and recorded.
Measured: 2 minutes
Timed Performance Test
Ascending-descending standard 4 steps, walking 10m, standing from lying position were used in order to assess the performance of children.The time passed during timed performance tests were recorded as seconds.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start10 Jun 2017
- Primary completion5 Aug 2017
- Study completion5 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerformanceStudies 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., Study director, 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
- NCT03529240
- Sponsor's protocol ID
- KA-17070
- Status last verified
- May 2018
- First submitted
- 6 May 2018
- Last updated
- 18 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 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinesiology Taping in Duchenne Muscular Dystrophy: Effects on Performance, Gait Characteristics, and Energy Consumption
- ClinicalTrials.gov ID
- NCT03529240
- Acronym / sponsor ID
- KA-17070
- Conditions
- Performance, Energy, Gait, Duchenne Muscular Dystrophy
- Keywords
- kinesiology taping, performance, energy consumption, gait, 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
- 5 Aug 2017 (actual)
- Study completion
- 5 Oct 2017 (actual)
- First posted
- 18 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 performance, energy consumption and gait characteristics 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. Performance was assessed by measuring the distance in 6-minute walk test (6MWT) and the duration of timed performance tests; energy consumption by Physiological Consumption Index (PCI), and gait characteristics by footprint method on powdered ground at baseline. Kinesiology taping 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 TapingAfter performing the baseline assessments, kinesiology taping with facilitation technique was applied on bilateral quadriceps and tibialis anterior muscles of children. In both applications, the first and last 5 cm section of the bands were used as anchor and no tension was applied. |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Duchenne Muscular Dystrophy diagnosis,
- age 5 to 14 years,
- able to cooperate with instructions of physiotherapist,
- able to walk independently,
- climb 4 steps independently/with minimal support from handrails.
Key exclusion criteria (3 listed)
- severe contracture at lower extremities,
- other disease except for DMD, and
- history of any injury or orthopaedic/neurologic surgery within the past 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 |
|---|---|---|
| Kinesiology TapingKinesiology taping (KT) which was developed by Dr. Kenzo Kase, is a new application of elastic and adhesive taping. KT is applied by specialized physiotherapists and physicians. This type of taping is a very frequently used technique to accelerate recovery after musculoskeletal injuries. Also, this technique is usually used as an alternative to athletic taping to support fascias, muscles, and joints for many purpose such as positioning, inhibition, and fascilitation | Device | Kinesiology taping |
Primary outcome
Six Minute Walk Test
Time frame: 6 minute
Six Minute Walk Test was used commonly in DMD were found to be valid, reliable and easy to apply in the clinic. Children were asked to walk during 6 minutes as fast as they can at a corridor specified by two cones and walking distances were recorded as meter (m) for 6MWT. The time passed during timed performance tests were recorded as seconds.
3 secondary outcomes
Energy Consumption
Time frame: 6 minutes
Gait
Time frame: 2 minutes
Timed Performance Test
Time frame: 10 minutes
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 18 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. study director
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 Taping in people with Performance and Energy, 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 5 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 18 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?
Six Minute Walk Test (time frame: 6 minute). 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 18 May 2018.