NCT07151534

Brief Summary

The aim of this study is to investigate the relationship between body awareness, trunk stabilization, and upper extremity functionality in patients with Multiple Sclerosis (MS). Hypotheses of the study: H1: There is a significant relationship between body awareness and upper extremity functionality in patients with MS. H2: There is a significant relationship between body awareness and trunk stabilization in patients with MS. H3: Body awareness is reduced in patients with MS compared to healthy individuals. H4: Trunk stabilization is reduced in patients with MS compared to healthy individuals. H5: Upper extremity functionality is reduced in patients with MS compared to healthy individuals.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
2mo left

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
Aug 2025Aug 2026

First Submitted

Initial submission to the registry

August 6, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

August 6, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 3, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2026

Expected
Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

10 months

First QC Date

August 6, 2025

Last Update Submit

May 20, 2026

Conditions

Keywords

body awarenessupper extremitytrunk stabilizationmultiple sclerosis

Outcome Measures

Primary Outcomes (12)

  • Body Awareness Questionnaire

    To assess body awareness, the Body Awareness Questionnaire will be used.This questionnaire consists of 18 items, each scored on a scale from 1 to 7, and evaluates body awareness. Higher scores indicate better body awareness. The Turkish version has been validated and found to be reliable.

    up to 6 months

  • Body Awareness Rating Questionnaire

    To assess body awareness,the Body Awareness Rating Questionnaire will be used. Body Awareness Rating Questionnaire:This questionnaire includes 24 items across 4 domains: function, mood, feeling/sensation, and awareness. Higher scores indicate better body awareness. The Turkish version has been validated and shown to be reliable.

    up to 6 months

  • Upper Extremity Functionality-Grip strength

    Grip strength will be measured with a Jamar dynamometer. It will be performed three times bilaterally, and average values (kg) will be recorded.

    up to 6 months

  • Upper Extremity Functionality-Pinch strength

    Pinch strengths will be assessed using a Baseline pinch gauge. It will be performed three times bilaterally, and average values (kg) will be recorded.

    up to 6 months

  • Upper Extremity Functionality-Nine Hole Peg Test (9HPT)

    The 9HPT will evaluate hand dexterity by timing how quickly participants place and remove nine pegs. Each hand will be tested three times. It will be recorded in seconds. An average time ≥33.3 seconds will indicate dysfunction in MS patients.

    up to 6 months

  • Trunk Stabilization- Trunk Impairment Scale (TIS),

    Trunk stabilization will be evaluated using the TIS.TIS: Assesses static/dynamic balance and trunk coordination (17 items, 0-23 points).

    up to 6 months

  • Trunk Stabilization-plank endurance test

    Trunk stabilization will be evaluated using the plank endurance test. The test measures core endurance. Plank test: Time held in forearm plank recorded. It will be recorded in seconds.

    up to 6 months

  • Trunk Stabilization-side bridge test

    Trunk stabilization will be evaluated using the side bridge test. The test measures core endurance Time held in side plank on both sides recorded.It will be recorded in seconds.

    up to 6 months

  • Trunk Stabilization-Modified Biering-Sorensen

    Trunk stabilization will be evaluated using the Modified Biering-Sorensen test. The test measures core endurance. Time holding trunk in horizontal position prone over table edge. It will be recorded in seconds.

    up to 6 months

  • Trunk Stabilization-Trunk flexor test

    Trunk stabilization will be evaluated using the Trunk flexor test test.The test measures core endurance. Time maintaining 60° trunk flexion with knees/hips at 90°. It will be recorded in seconds.

    up to 6 months

  • Trunk Stabilization-Sit up test

    The 30-second Sit-up Test measures core strength. The person lies on their back with knees bent and feet on the floor. They do as many sit-ups as possible in 30 seconds, keeping proper form. The score is the number of correct sit-ups completed.

    up to 6 months

  • Trunk Stabilization-Modifiye push up test

    The 30-second Modified Push-up Test measures core strength. The person starts in a push-up position but with knees on the floor. They perform as many push-ups as possible in 30 seconds, keeping the body straight and lowering the chest close to the ground. The score is the number of correct push-ups completed.

    up to 6 months

Study Arms (2)

Multiple Sclerosis

Diagnosed with Multiple Sclerosis (MS) by a neurologist according to the McDonald criteria, aged 18 years or older, Expanded Disability Status Scale (EDSS) score of ≤ 5, Mini-Mental State Examination score of 24 or higher will be included in the study.

Healthy

A control group consisting of healthy individuals matched with MS patients by age and sex will be included in the study.

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

MS patients and healthy subjects with inclusion criteria

You may qualify if:

  • Diagnosed with Multiple Sclerosis (MS) by a neurologist according to the McDonald criteria
  • Aged 18 years or older
  • Expanded Disability Status Scale (EDSS) score ≤ 5
  • Mini-Mental State Examination (MMSE) score ≥ 24
  • A control group consisting of healthy individuals matched with MS patients in terms of age and sex

You may not qualify if:

  • Having a neurological disorder other than MS
  • Having experienced a relapse and/or used corticosteroids in the past 3 months
  • Having an orthopedic/systemic condition affecting the upper extremities or trunk
  • Being pregnant
  • Refusing to participate or not providing written informed consent
  • Healthy individuals who have an orthopedic/systemic condition affecting the upper extremities or trunk, who are pregnant, or who do not agree to participate and provide written informed consent will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Altındağ, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Muhammed Kılınç

    Hacettepe University

    PRINCIPAL INVESTIGATOR
  • Özge Onursal Kılınç

    Hacettepe University

    STUDY DIRECTOR

Central Study Contacts

Güngör Beyza Özvar Şenöz

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 6, 2025

First Posted

September 3, 2025

Study Start

August 6, 2025

Primary Completion

May 20, 2026

Study Completion (Estimated)

August 6, 2026

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations