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Clinical Trials/NCT04353167
NCT04353167
Completed
Not Applicable

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

Hacettepe University1 site in 1 country38 target enrollmentMarch 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Foot Posture
Sponsor
Hacettepe University
Enrollment
38
Locations
1
Primary Endpoint
Gait instrumented walkway (GaitRite)
Status
Completed
Last Updated
3 years ago

Overview

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 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.

Registry
clinicaltrials.gov
Start Date
March 15, 2020
End Date
June 15, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Güllü AYDIN YAĞCIOĞLU

Principal Investigator

Hacettepe University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

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

  • Foot Posture Index - 6(10 minutes)
  • NewYork Posture Scale(10 minutes)

Study Sites (1)

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