Duchenne Muscular Dystrophy Clinical Trial
Official title:
Kinesiology Taping in Duchenne Muscular Dystrophy: Effects on Performance, Gait Characteristics, and Energy Consumption
NCT number | NCT03529240 |
Other study ID # | KA-17070 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 10, 2017 |
Est. completion date | October 5, 2017 |
Verified date | May 2018 |
Source | Hacettepe University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Investigators investigated that the effects of kinesilogy taping on performance, energy consumption and gait characteristics in patients with Duchenne Muscular Dystrophy
Status | Completed |
Enrollment | 45 |
Est. completion date | October 5, 2017 |
Est. primary completion date | August 5, 2017 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 5 Years to 14 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - severe contracture at lower extremities, - other disease except for DMD, and - history of any injury or orthopaedic/neurologic surgery within the past 6 months. |
Country | Name | City | State |
---|---|---|---|
Turkey | Hacettepe University | Ankara | Sihhiye |
Lead Sponsor | Collaborator |
---|---|
Hacettepe University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 6 minute | |
Secondary | 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) | 6 minutes | |
Secondary | 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. | 2 minutes | |
Secondary | 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. | 10 minutes |
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