NCT05559710

Brief 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, 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 29, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2023

Completed
Last Updated

December 5, 2023

Status Verified

November 1, 2023

Enrollment Period

12 months

First QC Date

September 26, 2022

Last Update Submit

November 29, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    15 minutes

Secondary Outcomes (4)

  • Movement Imagery Questionnaire-Children(MIQ-C)

    20 minutes

  • Modified Mini Mental Test (MMMT)

    5 minutes

  • Mini Mental State Test

    5 minutes

  • Montreal Cognitive Assessment Scale (MoCA)

    10 minutes

Study Arms (2)

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

Eligibility Criteria

Age7 Years - 18 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsBecause DMD is X linked recessive disorder, this disorder is seen in male
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06680, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Condition Hierarchy (Ancestors)

Muscular DystrophiesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

September 26, 2022

First Posted

September 29, 2022

Study Start

June 20, 2022

Primary Completion

June 19, 2023

Study Completion

September 25, 2023

Last Updated

December 5, 2023

Record last verified: 2023-11

Locations