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Effect of Foot Structure and Foot and Body Posture on Gait and Balance in Duchenne Muscular Dystrophy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment
Foot Posture Balance Gait Disorders, Neurologic Body Posture Other: observational evaluation

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
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



Intervention Details:
  • Other: observational evaluation
    Patients will be evaluated only observationally without intervention


Primary Outcome Measures :
  1. 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.

  2. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   5 Years to 13 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study population include just patients with Duchenne Muscular Dystrophy
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Güllü Aydın, MSc +905536140823 gulluaydin23@gmail.com
Contact: Öznur Yılmaz, Prof.

Locations
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Turkey
Hacettepe University Recruiting
Ankara, Sıhhiye, Turkey, 06100
Contact: Öznur Tunca Yılmaz, Prof.    +903123051576 ext 145    oznurtunca@yahoo.com   
Contact: Güllü Aydın, R.A    +903123051576 ext 179    gulluaydin23@gmail.com   
Sponsors and Collaborators
Hacettepe University
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Responsible Party: Güllü AYDIN, Principal Investigator, Hacettepe University
ClinicalTrials.gov Identifier: NCT04353167    
Other Study ID Numbers: GO19548
First Posted: April 20, 2020    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gait Disorders, Neurologic
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms