NCT05634993

Brief Summary

Trunk control disorders are frequently encountered in individuals with MS. Trunk control is very important for safe and quality movement. Impairment of trunk control reduces the level of independence of individuals during activities of daily living. For this reason, it is extremely important to evaluate the trunk in the examination and treatment of individuals. When the literature was examined, it was seen that studies examining trunk control were insufficient. Therefore, our study was planned to investigate the relationship between disability level and trunk control in individuals with MS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 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 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 2, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

February 7, 2025

Status Verified

February 1, 2025

Enrollment Period

1 year

First QC Date

November 11, 2022

Last Update Submit

February 6, 2025

Conditions

Keywords

multiple sclerosisdisability leveltrunk control

Outcome Measures

Primary Outcomes (8)

  • Expanded Disability Status Scale

    It is used for the follow-up of neurological disability and disease stage in MS patients. A score of 0 on the scale indicates normal neurological status, while a score of 10 means death due to MS. The higher the score, the higher the disability level.

    baseline

  • Trunk Impairment Scale

    This scale; It consists of 3 sub-headings: static sitting balance, dynamic sitting balance and coordination. The lowest score that can be obtained from the scale is 0, and the highest score is 23. The higher the score, the higher the trunk control.

    baseline

  • "Sit-ups" test

    This test is used to evaluate the strength of the core stability muscles. Individuals are asked to flex the trunk while the knees are flexed in the supine position. The number of repetitions they can do for 30 seconds is recorded.

    baseline

  • Modified "Push-ups" test

    This test is used to evaluate the strength of the core stability muscles. Individuals are asked to raise their body up by extending their elbows while in the prone position. The number of repetitions they can do for 30 seconds is recorded.

    baseline

  • Lateral bridge test

    This test is used to evaluate the endurance of the core stability muscles. Individuals are asked to lift their bodies on their forearms and toes in the side-lying position and maintain this position. The time held in the position is recorded. The test is done separately for the right and left sides.

    baseline

  • Modified "Biering-Sorensen" trunk extension test

    This test is used to evaluate the endurance of the core stability muscles. In the prone position, individuals are asked to hang their upper body over the edge of the bed and slightly extend them while their ankles are supported. The time held in the position is recorded.

    baseline

  • Trunk flexion test

    This test is used to evaluate the endurance of the core stability muscles. Individuals are asked to stand with their torso at 60º with the floor, and their knees and hips at 90º. The time held in the position is recorded.

    baseline

  • "Prone Bridge" test

    This test is used to evaluate the endurance of the core stability muscles.Individuals are asked to lift their torso up in the prone position while the elbows are flexed, carrying their body weight on their forearms and toes. The time held in the position is recorded.

    baseline

Study Arms (1)

MS Group

Other: Assessment

Interventions

Assessment of disability level and trunk control

MS Group

Eligibility Criteria

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

The population of the study will consist of patients who applied to the Neurology Outpatient Clinic for outpatient treatment and were diagnosed with Multiple Sclerosis by a neurologist and volunteered to participate in the study.

You may qualify if:

  • Being between the ages of 18-65
  • Having a definite diagnosis of MS
  • Expanded Disability Status Scale (EDSS) score of 8.5 and below
  • Not having an attack in the last 3 months

You may not qualify if:

  • Having another musculoskeletal, cardiovascular, pulmonary, metabolic, or neurological disease severe enough to preclude participation in the study.
  • Having severe vision and hearing problems
  • The presence of severe cognitive impairment detected by the physician at a level that prevents the tests from being performed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Melike Sumeyye Ozen

Bandırma, Balıkesir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Design

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

Study Record Dates

First Submitted

November 11, 2022

First Posted

December 2, 2022

Study Start

June 1, 2022

Primary Completion

June 1, 2023

Study Completion

September 1, 2023

Last Updated

February 7, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations