Duchenne Muscular DystrophyNCT05564962
Quality and Independence of Gait Classification Scale for DMD (QIGS-DMD)
An observational study of Duchenne Muscular Dystrophy and Gait Disorders in Children, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to develop a reliable and valid gait classification scale for Duchenne Muscular Dystrophy (QIGS-DMD). The items of the QIGS-DMD were designed based on the literature review considering existing functional classification scales, gait scales, and the opinions of the physiotherapists who were… Read more about this study
- Who is it for?
- Ages 5 to 18 years, men only
- Conditions the study is for
- Duchenne Muscular Dystrophy, Gait Disorders in Children
- What is being tested?
- Quality and Independence of Gait Classification Scale for Duchenne Muscular Dystrophy (QIGS-DMD)
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jan 2021to 20 Sep 2021
- 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 18 years
- Men only
- Child, Adult
Study population: Study population consisted of patients with Duchenne Muscular Dystrophy
Who may be able to join
- being 5 years old or above, and
- having a confirmed diagnosis of Duchenne Muscular Dystrophy.
Who cannot join
- having other coexisting medical or psychiatric diseases or injury and/or surgery related to the lower extremities within the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality and Independence of Gait Classification Scale for Duchenne Muscular Dystrophy (QIGS-DMD): The Development, Validity and Reliability
The aim of this study was to develop a reliable and valid gait classification scale for Duchenne Muscular Dystrophy (QIGS-DMD). The items of the QIGS-DMD were designed based on the literature review considering existing functional classification scales, gait scales, and the opinions of the physiotherapists who were expertized in rehabilitation of patients with DMD. Content validity was determined based on the opinions of a total of ten expert physiotherapists. Videos were recorded during gait of 69 children with DMD and inter- and intra-rater reliability were examined. Criterion validity was determined according to the relationship between QIGS-DMD and Motor Function Measure (MFM) and Vignos Lower Extremity Rating Scale (VLERS).
- Being tested
- Quality and Independence of Gait Classification Scale for Duchenne Muscular Dystrophy (QIGS-DMD)
- Keywords
- Duchenne Muscular Dystrophy, scale development, gait, classification, reliability, validitiy
- Medical subject headings
- Muscular Dystrophy, Duchenne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality and Independence of Gait Classification Scale for Duchenne Muscular Dystrophy (QIGS-DMD)Diagnostic test
Also called Motor Function Measure (MFM) and Vignos Lower Extremity Rating Scale (VLERS).
MFM is a valid and reliable measure to evaluate the severity of the motor deficit of both ambulatory and non-ambulatory children with neuromuscular diseases. MFM consists of 32 items in 3 dimensions and is scored as a percentage of the maximum possible score which higher scores indicate better functional status. VLERS is a 10-item ordinal scale that identifies the functional status of the lower limbs. According to VLERS, level 1 indicates that the patient can walk independently and climb stairs without assistance while level 10 indicates is the patient is bedridden.
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality and Independence of Gait Classification Scale for Duchenne Muscular Dystrophy (QIGS-DMD)
It is the scale developed within the scope of the study.
Measured: 10 minutes
Secondary outcomes (2)
Motor Fucntion Measure (MFM)
MFM is a valid and reliable measure to evaluate the severity of the motor deficit of both ambulatory and non-ambulatory children with neuromuscular diseases. MFM consists of 32 items in 3 dimensions and is scored as a percentage of the maximum possible score which higher scores indicate better functional status.
Measured: 20-30 minutes
Vignos Lower Extremity Rating Scale (VLERS)
VLERS is a 10-item ordinal scale that identifies the functional status of the lower limbs. According to VLERS, level 1 indicates that the patient can walk independently and climb stairs without assistance while level 10 indicates is the patient is bedridden
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 posted4 Oct 2022
- Study start19 Jan 2021
- Primary completion20 Jun 2021
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duchenne Muscular DystrophyStudies 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
- 69 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
- NCT05564962
- Sponsor's protocol ID
- QIGSDMD
- Status last verified
- Sep 2022
- First submitted
- 29 Sep 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality and Independence of Gait Classification Scale for Duchenne Muscular Dystrophy (QIGS-DMD): The Development, Validity and Reliability
- ClinicalTrials.gov ID
- NCT05564962
- Acronym / sponsor ID
- QIGSDMD
- Keywords
- Duchenne Muscular Dystrophy, scale development, gait, classification, reliability, validitiy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 20 Jun 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 4 Oct 2022 (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.
The aim of this study was to develop a reliable and valid gait classification scale for Duchenne Muscular Dystrophy (QIGS-DMD). The items of the QIGS-DMD were designed based on the literature review considering existing functional classification scales, gait scales, and the opinions of the physiotherapists who were expertized in rehabilitation of patients with DMD. Content validity was determined based on the opinions of a total of ten expert physiotherapists. Videos were recorded during gait of 69 children with DMD and inter- and intra-rater reliability were examined. Criterion validity was determined according to the relationship between QIGS-DMD and Motor Function Measure (MFM) and Vignos Lower Extremity Rating Scale (VLERS).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 18 years
- Sex
- Male only
- Age groups
- Child, Adult
- Study population
- Study population consisted of patients with Duchenne Muscular Dystrophy
Key inclusion criteria (2 listed)
- being 5 years old or above, and
- having a confirmed diagnosis of Duchenne Muscular Dystrophy.
Key exclusion criteria (1 listed)
- having other coexisting medical or psychiatric diseases or injury and/or surgery related to the lower extremities within the last 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 |
|---|---|---|
| Quality and Independence of Gait Classification Scale for Duchenne Muscular Dystrophy (QIGS-DMD)Also: Motor Function Measure (MFM) and Vignos Lower Extremity Rating Scale (VLERS).MFM is a valid and reliable measure to evaluate the severity of the motor deficit of both ambulatory and non-ambulatory children with neuromuscular diseases. MFM consists of 32 items in 3 dimensions and is scored as a percentage of the maximum possible score which higher scores indicate better functional status. VLERS is a 10-item ordinal scale that identifies the functional status of the lower limbs. According to VLERS, level 1 indicates that the patient can walk independently and climb stairs without assistance while level 10 indicates is the patient is bedridden. | Diagnostic test | – |
Primary outcome
Quality and Independence of Gait Classification Scale for Duchenne Muscular Dystrophy (QIGS-DMD)
Time frame: 10 minutes
It is the scale developed within the scope of the study.
2 secondary outcomes
Motor Fucntion Measure (MFM)
Time frame: 20-30 minutes
Vignos Lower Extremity Rating Scale (VLERS)
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 4 Oct 2022.
- 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 Duchenne Muscular Dystrophy and Gait Disorders in Children, 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 2 inclusion and 1 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 4 Oct 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?
Quality and Independence of Gait Classification Scale for Duchenne Muscular Dystrophy (QIGS-DMD) (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Oct 2022.