Foot PostureNCT04353167
Examination of the Relationship Between Foot - Body Posture and Balance and Gait in Duchenne Muscular Dystrophy
An observational study of Foot Posture and Balance, run by Hacettepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 5 to 13 years, men only
- Conditions the study is for
- Foot Posture, Balance, Gait Disorders, Neurologic
- What is being tested?
- observational evaluation
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2020to 15 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 13 years
- Men only
- No healthy volunteers
- Child
Study population: Study population include just patients with Duchenne Muscular Dystrophy
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- observational evaluation
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational evaluationOther
Patients will be evaluated only observationally without intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 10 minutes
Secondary outcomes (2)
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.
Measured: 10 minutes
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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start15 Mar 2020
- Primary completion15 Apr 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Foot PostureStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Güllü AYDIN YAĞCIOĞLU, Hacettepe University
- Investigators
- Güllü Aydın Yağcıoğlu, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04353167
- Sponsor's protocol ID
- GO19548
- Status last verified
- Jul 2022
- First submitted
- 16 Apr 2020
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Relationship Between Foot - Body Posture and Balance and Gait in Duchenne Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT04353167
- Acronym / sponsor ID
- GO19548
- Conditions
- Foot Posture, Balance, Gait Disorders, Neurologic, Body Posture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 20 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 13 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Study population include just patients with Duchenne Muscular Dystrophy
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational evaluationPatients will be evaluated only observationally without intervention | Other | – |
Primary outcome
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).
2 secondary outcomes
Foot Posture Index - 6
Time frame: 10 minutes
NewYork Posture Scale
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Derived from this study: PubMed 36205913Aydin 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Güllü Aydın Yağcıoğlu, PhD principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Foot Posture and Balance, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait instrumented walkway (GaitRite) (time frame: 10 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04353167, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.