- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04353167
Examination of the Relationship Between Foot - Body Posture and Balance and Gait in Duchenne Muscular Dystrophy
July 24, 2022 updated by: Güllü AYDIN YAĞCIOĞLU, Hacettepe University
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
38
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sıhhiye
-
Ankara, Sıhhiye, Turkey, 06100
- Hacettepe University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 11 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Study population include just patients with Duchenne Muscular Dystrophy
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
10 minutes
|
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).
|
10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
10 minutes
|
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.
|
10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2020
Primary Completion (Actual)
April 15, 2022
Study Completion (Actual)
June 15, 2022
Study Registration Dates
First Submitted
April 16, 2020
First Submitted That Met QC Criteria
April 16, 2020
First Posted (Actual)
April 20, 2020
Study Record Updates
Last Update Posted (Actual)
July 27, 2022
Last Update Submitted That Met QC Criteria
July 24, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO19548
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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