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

NCT04353167 | Completed

• 1 other identifier: GO19548
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Foot Posture; Balance; Gait Disorders, Neurologic; Body Posture

Outcome Measures

Primary Outcomes (2)

• 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.

  10 minutes

• 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).

  10 minutes

Secondary Outcomes (2)

• Foot Posture Index - 6

  10 minutes

• NewYork Posture Scale

  10 minutes

Interventions

observational evaluation OTHER

Patients will be evaluated only observationally without intervention

Eligibility Criteria

• Age: 5 Years - 13 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Study population include just patients with Duchenne Muscular Dystrophy

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Sıhhiye, 06100, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 36205913 DERIVED

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Güllü Aydın Yağcıoğlu, PhD

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 20, 2020
• Study Start: March 15, 2020
• Primary Completion: April 15, 2022
• Study Completion: June 15, 2022
• Last Updated: July 27, 2022

Record last verified: 2022-07

Locations

TU (1)