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

Balance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04353167
• Other study ID #: GO19548
• Status: Completed
• Start date: March 15, 2020
• Est. completion date: June 15, 2022

Study information

• Verified date: July 2022
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 15, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 5 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Balance
• Body Posture
• Foot Posture
• Gait Disorders, Neurologic
• Muscular Dystrophies
• Muscular Dystrophy, Duchenne
• Nervous System Diseases

Intervention

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

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara	Sihhiye

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	10 minutes
Secondary	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.	10 minutes