NCT04750733

Brief Summary

Optimal trunk control relies on somatosensory, motor and musculoskeletal integrity, which is often damaged in multiple sclerosis (MS). Researches on postural control in people with MS (PwMS) have revealed that reduced somatosensory conduction may adversely affect some functions. PwMS have increased postural sway in upright posture than healthy people. They move closer and slower when reaching out or taking a step. Trunk controls are weak and postural responses are delayed. The activation of core muscles is very important for an effective trunk control. Because the core region is considered a kinetic link that facilitates the transfer of torque and angular momentum between the upper and lower extremities during body movements. The decrease in core stability affects both trunk control and the quality of limb movements due to the kinetic chain in the body. There are a limited number of studies in the literature showing that core stability is reduced in PwMS. Our knowledge about the effects of this reduction on function in PwMS is very limited.

Trial Health

87
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
Completed

Started Feb 2021

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

February 20, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2022

Completed
Last Updated

July 8, 2022

Status Verified

July 1, 2022

Enrollment Period

1.4 years

First QC Date

February 7, 2021

Last Update Submit

July 7, 2022

Conditions

Keywords

Multiple sclerosiscore stabilitypostural controlisokinetic strengthphysical capacityfatigue

Outcome Measures

Primary Outcomes (4)

  • Core strength

    Core strength will be evaluated within the scope of core assessment. Curl-Up and Modified Push-Up test will be used for the evaluation of core strength.

    Baseline

  • Core endurance

    Core endurance will be evaluated within the scope of core assessment. Trunk flexor, extensor, lateral endurance and plank will be used in the evaluation of core endurance and recorded as seconds.

    Baseline

  • Postural sway

    Postural sways will be evaluated with biodex balance system in different condition such as open eyes on firm and foam surface, closed eyes on firm and foam surface, double stance on firm and foam surface, tandem stance on firm and foam surface.

    Baseline

  • İsokinetic strength

    Concentric isokinetic muscle strength of the knee flexor and extensor muscles will be evaluated with Biodex isokinetic dynamometer at angular velocities of 30,60 and 90°/s.

    Baseline

Secondary Outcomes (3)

  • Physical capacity

    Baseline

  • Mobility

    Baseline

  • Fatigue

    Baseline

Study Arms (1)

Multiple Sclerosis

Ambulatory MS patients

Other: Assessment

Interventions

Assessment of core strength and endurance, muscle strength, postural sway in different condition, physical capacity and fatigue

Multiple Sclerosis

Eligibility Criteria

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

People with MS followed in the Neurology Department of Bakirkoy Prof. Dr. Mazhar Osman Education and Research Hospital for Psychiatric and Neurological Diseases will be included.

You may qualify if:

  • Being diagnosed with MS according to McDonald's criteria
  • Disability level less than 6 according to EDSS (Expanded Disability Status Scale) score
  • No attacks during the last 3 months
  • Being an ambulatory
  • Volunteering to participate in the study

You may not qualify if:

  • Having orthopedic, neurological, psychological, etc. diseases that accompany MS and may affect treatment outcomes
  • Doing regular sports
  • Being involved in another physiotherapy and rehabilitation program related to MS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple SclerosisFatigue

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

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
Physiotherapist, Research Assistant

Study Record Dates

First Submitted

February 7, 2021

First Posted

February 11, 2021

Study Start

February 20, 2021

Primary Completion

July 1, 2022

Study Completion

July 5, 2022

Last Updated

July 8, 2022

Record last verified: 2022-07

Locations