Duchenne Muscular DystrophyNCT05559710
Motor Imagery in Duchenne Muscular Dystrophy
An observational study of Duchenne Muscular Dystrophy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Motor imagery (MI) can be defined as a dynamic process in which the person is mentally stimulated without performing the given motor movement. Studies of imagery; demonstrated that it alters a person's ability to learn, performance skills, and important cognitive skills (self-efficacy, self-confidence, effort… Read more about this study
- Who is it for?
- Ages 7 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Duchenne Muscular Dystrophy
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2022to 25 Sep 2023
- 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 7 to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Study population: Duchenne Muscular Dystrophy (DMD), X-linked recessive It is a genetic disease that is inherited and has a prevalence of approximately 1/3600-6000 live male births. The disorder is caused by a mutation in the dystrophin gene located on the X chromosome, resulting in complete or partial absence of the dystrophin protein in the cell membrane, resulting in irreversible progressive loss of functional abilities. The symptoms are manifested by gait disturbance between 3-5 years of age, primarily due to progressive weakness in the proximal muscles. Delayed gait, toe walking, duck-like gait, difficulty climbing stairs and running are early signs of Gower's sign. Gait begins to deteriorate between the ages of 3 and 6, and patients become wheelchair dependent at around 10-12 years of age.
Who may be able to join
- Having a diagnosis of DMD confirmed by a genetic test result,
- Be between the ages of 7-18,
- More than 27 (27-35 indicates normal cognitive level) from the Modified Mini Mental Test of children aged 7-15 years to be able to cooperate with the physiotherapist's instructions; Children between the ages of 16-18 get more than 24 points from the Mini Mental State Test (24-30 points indicate no cognitive impairment, 20-23 indicates mild, 10-19 moderate, and below 9 indicates severe cognitive impairment),
- Ability to sit for at least 30 minutes with/without support,
- Volunteering to participate in the study.
Who cannot join
- Insufficient cooperation with the physiotherapist,
- Any injury and/or surgery to the lower/upper extremities in the last 6 months
- Having any additional neurological/orthopedic problems other than DMD.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Validity and Reliability of the Kinesthetic and Visual Imagery Questionnaire in Children With Duchenne Muscular Dystrophy
Motor imagery (MI) can be defined as a dynamic process in which the person is mentally stimulated without performing the given motor movement. Studies of imagery; demonstrated that it alters a person's ability to learn, performance skills, and important cognitive skills (self-efficacy, self-confidence, effort, motivation). In recent years, it has been shown that motor imagery techniques are used for therapeutic purposes as a current neurorehabilitation approach and that imagery can have positive effects on improving motor activity and functions. However, it has been reported that the biggest difficulty in the use of imagery techniques is the inability to determine to what extent the individual can perform mental representation of movements. For this reason, it is thought that it is necessary to evaluate the motor imagery ability first in order to identify the patients who are suitable for motor imagery training. The Kinesthetic and Visual Imagery Questionnaire (KVIQ) is a motor imagery questionnaire developed for individuals with limited mobility for different reasons. The questionnaire assesses both the visual and kinesthetic dimensions of motor imagery. of the KVIQ; It has also been shown in the literature that it is a valid and reliable questionnaire that enables the appropriate evaluation of motor imagery in different neurological disease groups such as Multiple Sclerosis, Parkinson's disease, and stroke. However, the literature When examined, no evidence was found about the motor imagery ability of individuals with Duchenne muscular dystrophy (DMD). It is foreseen that KVIQ will be especially suitable for patients with DMD of different functional levels, since all its items have been developed to be applied to people with limited physical mobility or physically disabled people in a sitting position. Therefore, in this study, it is aimed to investigate the validity and reliability of the Kinesthetic and Visual Imagery Questionnaire for patients with DMD.
Read the detailed description
DMD and age matched healthy individuals will be participate the study between the ages of 7 and 18 years.
Children who cannot cooperate with the physiotherapist adequately and who have had any injury and/or surgery to the lower/upper extremities in the last 6 months will not be included in the study.
- Conditions
- Duchenne Muscular Dystrophy
- 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.
| Study group | Role | What they receive |
|---|---|---|
| DMD Group | Children with Duchenne Muscular Dystrophy (DMD) between the ages of 7 and 18 who have been diagnosed with DMD as a result of genetic testing | |
| Healthy Controls | Helathy children with similar physical characteristics between the ages of 7 and 8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinesthetic and Visual Imagery Questionnaire (KVIQ)
he Kinesthetic and Visual Imagery Questionnaire is a representative tool to assess motor imagery ability. The questionnaire can be used to assess healthy individuals, as well as those with physical disabilities. It allows easy evaluation of motor imagery ability in a sitting position with single joint motions. Furthermore, the questionnaire assesses both visual and kinesthetic dimensions of motor imagery. The questionnaire is not self-administered, rather it is administered by a trained assessor. It assesses the vividness of each dimension of motor imagery (clarity of the image/intensity of sensation) on a 5-point ordinal scale.The long version comprises 20 items (10 movements for each scale) and the short version includes 10 items (5 movements for each scale). Higher scores mean a better outcome.
Measured: 15 minutes
Secondary outcomes (4)
Movement Imagery Questionnaire-Children(MIQ-C)
Visual and Kinesthetic motor imagery ability will be evaluated with MIQ-C. Includes 12 items in total. The individual is asked to visualize four different movements from three different imagery perspectives. The clearness of the imagination is scored using a Likert-type scale between 1 (very difficult to feel) -7 (very easy to feel)
Measured: 20 minutes
Modified Mini Mental Test (MMMT)
This test; orientation, memory (recording), attention and calculation, recall and language subtests. The highest score that can be obtained from MMMT is 35. The application time of the test is approximately 5-10 minutes. It has been reported that this test is a suitable tool for the examination of mental functions from the age of 4 and can be easily included in routine neurological examinations of children. Children between the ages of 7 and 15 who get 27 points below the MMMT will be excluded from the study. Children's total score will be recorded
Measured: 5 minutes
Mini Mental State Test
A mini mental state test will be used to evaluate the mental state of children aged 16-18. Test; It evaluates verbal responses including attention, orientation, memory and language skills, ability to obey verbal and written orders, write spontaneous sentences, and copy a complex drawing. The maximum score that can be obtained from the test is 30, the minimum score is 0.
Measured: 5 minutes
Montreal Cognitive Assessment Scale (MoCA)
In this test, which was developed as a rapid screening test for mild cognitive disorders; 8 different cognitive functions are evaluated, including attention, concentration, executive functions, memory, language, visual construction skills, abstract thinking, calculation and orientation. The application time of MoCA, which evaluates abstract thinking in addition to the other test, is approximately 10 minutes. The minimum score that can be taken from the test is 0 and the maximum score is 30. Accordingly, a score of 21 and above indicates normal cognitive functions.
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 posted29 Sep 2022
- Study start20 Jun 2022
- Primary completion19 Jun 2023
- Study completion25 Sep 2023
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 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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Bora, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559710
- Sponsor's protocol ID
- GO 22/750
- Status last verified
- Nov 2023
- First submitted
- 26 Sep 2022
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bora-Zereyak M, Bulut N, Yilmaz O, Alemdaroglu-Gurbuz I. Motor imagery ability of children with duchenne muscular dystrophy: Reliability and validity of kinesthetic and Visual Imagery Questionnaire-10, and its association with cognitive status. Eur J Paediatr Neurol. 2024 Jul;51:118-124. doi: 10.1016/j.ejpn.2024.06.003. Epub 2024 Jun 15.
PubMed 38917696
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Validity and Reliability of the Kinesthetic and Visual Imagery Questionnaire in Children With Duchenne Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT05559710
- Acronym / sponsor ID
- GO 22/750
- Conditions
- Duchenne Muscular Dystrophy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 19 Jun 2023 (actual)
- Study completion
- 25 Sep 2023 (actual)
- First posted
- 29 Sep 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.
Motor imagery (MI) can be defined as a dynamic process in which the person is mentally stimulated without performing the given motor movement. Studies of imagery; demonstrated that it alters a person's ability to learn, performance skills, and important cognitive skills (self-efficacy, self-confidence, effort, motivation). In recent years, it has been shown that motor imagery techniques are used for therapeutic purposes as a current neurorehabilitation approach and that imagery can have positive effects on improving motor activity and functions. However, it has been reported that the biggest difficulty in the use of imagery techniques is the inability to determine to what extent the individual can perform mental representation of movements. For this reason, it is thought that it is necessary to evaluate the motor imagery ability first in order to identify the patients who are suitable for motor imagery training. The Kinesthetic and Visual Imagery Questionnaire (KVIQ) is a motor imagery questionnaire developed for individuals with limited mobility for different reasons. The questionnaire assesses both the visual and kinesthetic dimensions of motor imagery. of the KVIQ; It has also been shown in the literature that it is a valid and reliable questionnaire that enables the appropriate evaluation of motor imagery in different neurological disease groups such as Multiple Sclerosis, Parkinson's disease, and stroke. However, the literature When examined, no evidence was found about the motor imagery ability of individuals with Duchenne muscular dystrophy (DMD). It is foreseen that KVIQ will be especially suitable for patients with DMD of different functional levels, since all its items have been developed to be applied to people with limited physical mobility or physically disabled people in a sitting position. Therefore, in this study, it is aimed to investigate the validity and reliability of the Kinesthetic and Visual Imagery Questionnaire for patients with DMD.
Detailed description
DMD and age matched healthy individuals will be participate the study between the ages of 7 and 18 years.
Children who cannot cooperate with the physiotherapist adequately and who have had any injury and/or surgery to the lower/upper extremities in the last 6 months will not be included in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DMD Group | – | –Children with Duchenne Muscular Dystrophy (DMD) between the ages of 7 and 18 who have been diagnosed with DMD as a result of genetic testing |
| Healthy Controls | – | –Helathy children with similar physical characteristics between the ages of 7 and 8 |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Duchenne Muscular Dystrophy (DMD), X-linked recessive It is a genetic disease that is inherited and has a prevalence of approximately 1/3600-6000 live male births. The disorder is caused by a mutation in the dystrophin gene located on the X chromosome, resulting in complete or partial absence of the dystrophin protein in the cell membrane, resulting in irreversible progressive loss of functional abilities. The symptoms are manifested by gait disturbance between 3-5 years of age, primarily due to progressive weakness in the proximal muscles. Delayed gait, toe walking, duck-like gait, difficulty climbing stairs and running are early signs of Gower's sign. Gait begins to deteriorate between the ages of 3 and 6, and patients become wheelchair dependent at around 10-12 years of age.
Key inclusion criteria (5 listed)
- Having a diagnosis of DMD confirmed by a genetic test result,
- Be between the ages of 7-18,
- More than 27 (27-35 indicates normal cognitive level) from the Modified Mini Mental Test of children aged 7-15 years to be able to cooperate with the physiotherapist's instructions; Children between the ages of 16-18 get more than 24 points from the Mini Mental State Test (24-30 points indicate no cognitive impairment, 20-23 indicates mild, 10-19 moderate, and below 9 indicates severe cognitive impairment),
- Ability to sit for at least 30 minutes with/without support,
- Volunteering to participate in the study.
Key exclusion criteria (3 listed)
- Insufficient cooperation with the physiotherapist,
- Any injury and/or surgery to the lower/upper extremities in the last 6 months
- Having any additional neurological/orthopedic problems other than DMD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Kinesthetic and Visual Imagery Questionnaire (KVIQ)
Time frame: 15 minutes
he Kinesthetic and Visual Imagery Questionnaire is a representative tool to assess motor imagery ability. The questionnaire can be used to assess healthy individuals, as well as those with physical disabilities. It allows easy evaluation of motor imagery ability in a sitting position with single joint motions. Furthermore, the questionnaire assesses both visual and kinesthetic dimensions of motor imagery. The questionnaire is not self-administered, rather it is administered by a trained assessor. It assesses the vividness of each dimension of motor imagery (clarity of the image/intensity of sensation) on a 5-point ordinal scale.The long version comprises 20 items (10 movements for each scale) and the short version includes 10 items (5 movements for each scale). Higher scores mean a better outcome.
4 secondary outcomes
Movement Imagery Questionnaire-Children(MIQ-C)
Time frame: 20 minutes
Modified Mini Mental Test (MMMT)
Time frame: 5 minutes
Mini Mental State Test
Time frame: 5 minutes
Montreal Cognitive Assessment Scale (MoCA)
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 5 Dec 2023.
- Derived from this study: PubMed 38917696Bora-Zereyak M, Bulut N, Yilmaz O, Alemdaroglu-Gurbuz I. Motor imagery ability of children with duchenne muscular dystrophy: Reliability and validity of kinesthetic and Visual Imagery Questionnaire-10, and its association with cognitive status. Eur J Paediatr Neurol. 2024 Jul;51:118-124. doi: 10.1016/j.ejpn.2024.06.003. Epub 2024 Jun 15.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, 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 5 inclusion and 3 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 5 Dec 2023. 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?
Kinesthetic and Visual Imagery Questionnaire (KVIQ) (time frame: 15 minutes). 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 NCT05559710, 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 5 Dec 2023.