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Completed

NCT Number: NCT04353167

Examination of the Relationship Between Foot - Body Posture and Balance and Gait in Duchenne Muscular Dystrophy

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 characteristics 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.

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Key information

Conditions

Foot Posture Balance Body Posture Gait Disorders, Neurologic Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

5 year–13 year

Sex eligibility

Male

Study type

Observational

Primary location

Hacettepe University

Ankara, Sıhhiye, 06100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • To be between 5-13 years old
  • Being at level I or II according to Brooke Lower Extremity Functional Classification Scale
  • 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.
  • Agree to participate in the research voluntarily

Exclusion criteria

  • Having serious mental and psychological problems,
  • Failure to cooperate adequately with the physiotherapist making the evaluations,
  • Severe contracture in lower extremities,
  • Any injury and / or surgery of the lower extremities in the past 6 months.

Treatment and study plan

observational evaluation

Other

Patients will be evaluated only observationally without intervention

Primary outcomes

  1. Gait instrumented walkway (GaitRite)

    Time frame: 10 minutes

    The GAITRite® system 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 System (Bertec)

    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 outcomes

  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 kept slightly anterior to right malleolus for assessing posture in sagittal plane and at midpoint between the feet for assessing in the frontal plane. Scoring is done 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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 20, 2020
Registry last updated
Jul 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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