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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
Sponsor:
Information provided by (Responsible Party):
Güllü AYDIN, Hacettepe University

Tracking Information
First Submitted Date April 16, 2020
First Posted Date April 20, 2020
Last Update Posted Date July 29, 2020
Actual Study Start Date June 15, 2019
Actual Primary Completion Date March 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 19, 2020)
  • 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).
Original Primary Outcome Measures
 (submitted: April 16, 2020)
  • GaitRite instrumented walkway [ Time Frame: 10 minutes ]
  • Bertec Balance [ Time Frame: 10 minutes ]
Change History
Current Secondary Outcome Measures
 (submitted: April 19, 2020)
  • 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.
Original Secondary Outcome Measures
 (submitted: April 16, 2020)
  • Foot Posture Index - 6 [ Time Frame: 10 minutes ]
  • NewYork Posture Scale [ Time Frame: 10 minutes ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effect of Foot Structure and Foot and Body Posture on Gait and Balance in Duchenne Muscular Dystrophy
Official Title Hacettepe University
Brief Summary Foot and body postures of patients with DMD will be evaluated. Foot structure characteristics such as foot length, metatarsal width, calcaneal valgus angle will be calculated for the foot posture. Also, the Foot Posture Index (FPI-6) scale will be used. The body posture will be evaluated with the New York Posture Scale. Many gait fcharacteristics such as step length, cadence, support surface of the patients will be determined with GaitRite instrumented walkway. Patients' balance assessment will be evaluated with Bertec Balance Advantage. The statistical analysis method will determine the relationship between foot and body posture and gait and balance.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Study population include just patients with Duchenne Muscular Dystrophy
Condition
  • Foot Posture
  • Balance
  • Gait Disorders, Neurologic
  • Body Posture
Intervention Other: observational evaluation
Patients will be evaluated only observationally without intervention
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 16, 2020)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 10, 2020
Actual Primary Completion Date March 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. To be between 5-13 years old
  2. Being at level I or II according to Brooke Lower Extremity Functional Classification Scale
  3. In the balance assessment, there should be at least 90 degrees of joint range of motion in the ankle to provide base contact on the force platform.
  4. Agree to participate in the research voluntarily

Exclusion Criteria:

  1. Having serious mental and psychological problems,
  2. Failure to cooperate adequately with the physiotherapist making the evaluations,
  3. Severe contracture in lower extremities,
  4. Any injury and / or surgery of the lower extremities in the past 6 months.
Sex/Gender
Sexes Eligible for Study: Male
Ages 5 Years to 13 Years   (Child)
Accepts Healthy Volunteers No
Contacts
Contact: Güllü Aydın, MSc +905536140823 gulluaydin23@gmail.com
Contact: Öznur Yılmaz, Prof.
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT04353167
Other Study ID Numbers GO19548
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Güllü AYDIN, Hacettepe University
Study Sponsor Hacettepe University
Collaborators Not Provided
Investigators Not Provided
PRS Account Hacettepe University
Verification Date July 2020