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CompletedNCT04353167Updated Jul 27, 2022

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

An observational study in Foot Posture, Balance and Gait Disorders, Neurologic, sponsored by Hacettepe University. Completed at 1 site in Turkey. Open to male participants aged 5 Years to 13 Years. Per ClinicalTrials.gov, last updated 2022-07-27.

Sponsored by Hacettepe University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
38
Ages
5 Years to 13 Years
Sex
Male
01

Study 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.

02

Conditions studied

03

In context

Muscular Dystrophies

548 studies on the registry are indexed under Muscular Dystrophies; 89 are open to participants now.

This study's enrollment of 38 is below the median of 69 across 179 observational studies indexed under Muscular Dystrophies.

Browse Muscular Dystrophies studies →

Lead sponsor

Hacettepe University is the lead sponsor of 983 studies on the registry; 212 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 13 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Study population include just patients with Duchenne Muscular Dystrophy

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
38 participants (actual)
Patient registry
No

Interventions

  • Otherobservational evaluation

    Patients will be evaluated only observationally without intervention

06

What researchers measure

Primary outcomes

  1. Gait instrumented walkway (GaitRite)

    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.

    Time frame: 10 minutes

  2. Bertec Balance System (Bertec)

    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).

    Time frame: 10 minutes

Secondary outcomes

  1. Foot Posture Index - 6

    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.

    Time frame: 10 minutes

  2. NewYork Posture Scale

    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.

    Time frame: 10 minutes

07

Study locations

1 site
  • Hacettepe University
    Ankara, Sıhhiye 06100, Turkey
08

References and documents

Publications

  • Aydin Yagcioglu G, Yilmaz O, Alemdaroglu Gurbuz I, Bulut N, Karaduman A, Ozkal O, Topuz S. Examination of the relationship between foot-body posture and balance and gait in Duchenne muscular dystrophy. Ir J Med Sci. 2023 Aug;192(4):1883-1888. doi: 10.1007/s11845-022-03178-5. Epub 2022 Oct 7. PubMed 36205913 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04353167
Lead sponsor
Hacettepe University
Responsible party
Güllü AYDIN YAĞCIOĞLU (Principal Investigator, Hacettepe University) — Principal investigator
First posted
Apr 20, 2020
Start date
Mar 15, 2020
Primary completion
Apr 15, 2022
Completion
Jun 15, 2022
Last update
Jul 27, 2022

Study contacts

Güllü Aydın Yağcıoğlu, PhD
principal investigator · Hacettepe University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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