Effect of Foot Structure and Foot and Body Posture on Gait and Balance in Duchenne Muscular Dystrophy
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|ClinicalTrials.gov Identifier: NCT04353167|
Recruitment Status : Recruiting
First Posted : April 20, 2020
Last Update Posted : July 29, 2020
|Condition or disease||Intervention/treatment|
|Foot Posture Balance Gait Disorders, Neurologic Body Posture||Other: observational evaluation|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Hacettepe University|
|Actual Study Start Date :||June 15, 2019|
|Actual Primary Completion Date :||March 15, 2020|
|Estimated Study Completion Date :||September 10, 2020|
- Other: observational evaluation
Patients will be evaluated only observationally without intervention
- GaitRite instrumented walkway [ Time Frame: 10 minutes ]The GAITRite® mat was positioned on the floor and connected to a laptop computer, with a 2 m acceleration/deceleration walkway at either end. Subjects were asked to walk at their typical speed to the designated end of the walkway.
- Bertec Balance [ Time Frame: 10 minutes ]The system consists of a 20 × 20-inch platform at ground level connected to a laptop computer. The balance plate detects body sway based on the pressure that the subject's feet apply to the plate surface. For testing, each subject stood for 10 seconds under 4 different testing conditions. The first two conditions were eyes open and eyes closed on the balance plate itself, defined as normal stability - eyes open (NSEO) and normal stability - eyes closed (NSEC). These were followed by the patient standing on a 4-inch thick foam rubber pad while on the balance plate. These were labeled as perturbed stability - eyes open (PSEO) and perturbed stability - eyes closed (PSEC). The primary measure assessed by the balance plate for each condition was maximum center of pressure excursion or COP (a distance measured in inches of the major axis of an ellipse calculated along the axis of maximum excursion).
- Foot Posture Index - 6 [ Time Frame: 10 minutes ]The Foot Posture Index - 6 (FPI-6) was evaluated with each child standing and using the original protocol. FPI-6 values ranged from -2 to +2 for each of the six criteria and from -12 to +12 for the total score, indicative of position of each foot along the supinated to pronated continuum of foot posture.
- NewYork Posture Scale [ Time Frame: 10 minutes ]The assessment of posture was done by New York Posture Rating Scale in which subjects were asked to stand in position of comfort and look forward on the wall at their eye level in order to establish a level head position. Then the plumb line was keptslightly anterior to right malleolus for assessing posture in sagittal plane and at midpoint between the feet for assessingin the frontal plane. Scoring isdone as 5, 3, 1 for no deviation, some deviation and marked deviation respectively for each 13 criteria in the rating scale of which components are head, shoulder, spine, hip, feet, arches in the frontal plane and head, chest, shoulder, upper back, trunk, abdomen and low back in the sagittal plane.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04353167
|Contact: Güllü Aydın, MScfirstname.lastname@example.org|
|Contact: Öznur Yılmaz, Prof.|