NCT06572059

Brief Summary

Multiple sclerosis (MS) is a chronic inflammatory and autoimmune disease of the central nervous system (CNS) characterised by axonal loss and demyelination. MS is characterized by myelin, oligodendrocyte and axon damage. MS progresses in a wide spectrum, with motor, sensory, autonomic and cognitive disorders depending on the area affected. Upper extremity dysfunction is common in patients with MS (pwMS), too. 75% of pwMS have impaired ability to perform activities of daily living (ADL) and quality of life (QoL). Motor imagery (MI) refers to the mental simulation of an action without physical intervention. MS is also characterised by motor and cognitive symptoms. Cognitive impairment, seen in approximately 40-70% of patients, is mainly related to problems in attention, information processing speed, memory, cognitive and visual structure. MI refers to the mental simulation of an action without physical intervention, which can be classified as explicit or implicit. MI skill is linked to motor planning and execution skills. MI is related to the subconscious activation of motor systems that play a role not only in producing movement, but also in imagining actions, learning through observation, recognising tools, and also understanding other people's behaviour.The speed and quality of upper extremity functional skills in pwMS may be related to MI ability. Health-related quality of life (HRQoL) is an individual's assessment of how a health problem and its treatment affect their ability to perform daily activities and roles. Research studies have shown that pwMS report lower QoL scores than healthy controls. Losses in upper extremity functional skills may affect the activities of daily living and work life in pwMS, leading to a decrease in their QoL. When evaluating MI ability in these patients, the patient's functional skills and cognitive status should also be taken into consideration. It is thought that upper extremity MI skills may be negatively affected by impairments with the cognitive syptoms in pwMS. The aim of this study is to investigate the relationship between upper extremity MI ability, upper extremity functional skills and QoL in pwMS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

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

July 7, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 26, 2024

Completed
Last Updated

August 29, 2024

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

August 22, 2024

Last Update Submit

August 27, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • The Kinesthetic and Visual Imagery Questionnaire (KVIQ)

    It was created by Malouin and his colleagues in 2007 based on the KVIQ to assess the kinesthetic and visual imagery abilities of healthy and physically disabled individuals. The movements in the items in the questionnaire are first physically performed by the individual and then the same movement is imagined. The clarity of visual imagery and the intensity of kinesthetic imagery are scored on a 5-point scale. Since the Kinesthetic and Visual Imagery Questionnaire includes simple movements performed while sitting, it was developed for individuals who cannot stand for various reasons, cannot perform complex movements, and need guidance during imagery. A higher score indicates better kinesthetic perception. Minimum score is 20 and maxmum score is 100.

    1st day of the interview

  • Mental Stopwatch

    Mental chronometry is based on comparing the time taken to perform a movement with the time taken to image the same movement. The score obtained from mental chronometry can be affected by various factors such as the duration of the activity, complexity, type of motor imagery (kinesthetic or visual) and the instructions given. Mental chronometry is related to the individual's ability to maintain and control the imaged image. Mental chronometry is based on the comparison between the physical execution time of a task and the imagined one, with a close temporal relationship indicating correct MI. In our study, DDPT will be used as the mental chronometry evaluation method due to its practicality and accessibility.

    1st day of the interview

  • Nine Hole Peg Test (NHPT)

    It was first introduced by Kellor et al. in 1971. During the test, the patient sits at a table with a 9-hole board in front of him, inserts and removes wooden or plastic rods into 9 empty holes. The insertion and removal times are recorded. The test is performed 3 times in succession for the dominant hand and the non-dominant hand. The test score is the average of these three trials. In our study, the NHPT will be applied as a mental stopwatch test. In the application part, after a practice trial, three physical applications and three motor imagery trials will be performed for each hand, respectively. During the imagery trials, participants will be instructed to use visual images from a first-person perspective and will be asked to imagine performing the same task physically. The average time of these three physical applications and imagery trials for both hands will be calculated and recorded.

    1st day of the interview

  • Jebson-Taylor Hand Function Test (JTHFT)

    It was developed in 1969 to evaluate the effectiveness of treatment and disability in patients with hand injuries. The JTHFT consists of tasks aimed at evaluating a wide range of one-handed hand functions required for daily living activities. The 7 test items required to be performed must be repeated for both hands. The functions of both hands are evaluated with the following operations; writing, turning over 8x13 cm paper cards, picking up small objects, simulating eating, stacking backgammon-checker checkers, picking up large objects, picking up large and heavy objects. The completion time of each task is recorded separately. The tasks are performed using both hands, first the non-dominant hand. The total application time of the test is around 45 minutes.

    1st day of the interview1

  • Manual Ability Measure-36 (MAM-36)

    MAM-36 has been used to assess subjective upper extremity function in people with a variety of neurological and non-neurological diseases. Additionally, the MAM-36 is one of the most commonly used patient-reported outcome measures in patients with multiple sclerosis (pwMS). The MAM-36 contains 36 items asking about the perceived ease or difficulty of performing common tasks; rated on a 4-point Likert-type scale from 0 (almost not performed) to 4 (easy).Higher MAM-36 scores indicate higher functional ability.

    1st day of the interview

  • multiple sclerosis impact scale-29

    It is a scale that evaluates the quality of life in MS patients, developed by Hobart et al. in 2001. It contains 20 statements covering physical parameters related to MS disease and a 9-item statement covering psychological problems. The physical section includes items from 1 to 20. The psychological section is ranked from 21 to 29. Participants are asked to answer each item regarding the impact of the condition on their daily lives in the last two weeks. Patients select the response that most strongly represents their condition and respond to each item on a 5-point Likert scale. The patient's scores on the two subscales can be added and converted to a measurement between 0 and 100. Higher scores indicate higher disease impact.

    1st day of the interview

Secondary Outcomes (4)

  • Expanded disability status scale (EDSS)

    1st day of the interview

  • Mini-Mental State Examination (MMSE)

    1st day of the interview

  • Fatigue Severity Scale (FSS)

    1st day of the interview

  • Beck Depression Inventory (BDI)

    1st day of the interview

Study Arms (2)

study/1(Assesments will be done for once)

It will consist of individuals with MS (\>18years old). who were followed up in the Multiple Sclerosis clinic of the Neurology Department of Kahramanmaraş Sutcu Imam University (KSU) Health Practice and Research Hospital. Patients who meet the inclusion criteria will be evaluated using the following parameters, respectively: * EDSS score (patient reports recorded by the physician will be used.) * Demographic information * Fatigue Severity Scale (FSS) * Beck Depression Inventory (BDI) * Kinesthetic and Visual Imagery Questionnaire (KVIQ) * Mental Chronometer Test (Nine-Hole Peg Test (DDPT) will be used.) * Jebson-Taylor Hand Function Test (JHEFT) * Manual Ability Test (MAM-36) * Multiple Sclerosis Impact Scale (MSIS-29) Assesments will be done for once.

Other: assesments for once

healthy control/2 (Assesments will be done for once)

It will consist of individuals with healthy volunteers with the similar age (\>18years old). Healthy volunteers who meet the inclusion criteria will be evaluated using the following parameters, respectively: * EDSS score (patient reports recorded by the physician will be used.) * Demographic information * Fatigue Severity Scale (FSS) * Beck Depression Inventory (BDI) * Kinesthetic and Visual Imagery Questionnaire (KVIQ) * Mental Chronometer Test (Nine-Hole Peg Test (DDPT) will be used. * Jebson-Taylor Hand Function Test (JHEFT) * Manual Ability Test (MAM-36) * Multiple Sclerosis Impact Scale (MSIS-29) Assesments will be done for once.

Other: assesments for once

Interventions

* EDSS score (patient reports recorded in the physician's record will be used.) * Demographic information * Fatigue Severity Scale (FSS) * Beck Depression Inventory (BDI) * Kinesthetic and Visual Imagery Questionnaire (KSVI) * Mental Chronometer Test (Nine-Hole Peg Test (DDPT)) will be used.) * Jebson-Taylor Hand Function Test (JHEFT) * Manual Ability Test (MAM-36) * Multiple Sclerosis Impact Scale (MSIS-29)

healthy control/2 (Assesments will be done for once)study/1(Assesments will be done for once)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Inclusion Criteria: * Have a confirmed MS diagnosis according to the revised McDonald criteria * Be 18 years of age or older * Have a Mini Mental Test score of 24 or higher * Have not changed medication in the last 6 months * Have not had an attack in the last 3 months Exclusion Criteria: * Being pregnant * Having a neuromusculoskeletal disease other than Multiple Sclerosis * Having any contractures in the upper extremity

You may qualify if:

  • Being 18 years old or older
  • Mini Mental Test score of 24 or higher
  • No neuro-musculoskeletal disease

You may not qualify if:

  • Being pregnant
  • Having a neuromusculoskeletal disease other than Multiple Sclerosis
  • Having any contractures in the upper extremity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hatice Adiguzel

Kahramanmaraş, Onikisubat, 46040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple SclerosisMotor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Study Officials

  • Mehmet Ozkeskin, Pt, PhD

    Ege University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asistant Professor

Study Record Dates

First Submitted

August 22, 2024

First Posted

August 26, 2024

Study Start

July 7, 2023

Primary Completion

October 30, 2023

Study Completion

October 30, 2023

Last Updated

August 29, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations