NCT03597451

Brief Summary

Muscle weakness, which is one of the most common symptoms in patients with MS, limits the activities of daily life activities of patients by causing balance and gait disturbance. Lower extremity muscle strengths of MS patients are reported to be weaker than healthy individuals. Broekmans et al. showed that the weakness of the knee flexor and extensor muscles in patients with MS caused a decrease in walking distance and they are important determinants of walking capacity. The effects of the endurance and strength of core muscles, as well as the extremity muscles, are important on physical performance. The weakness of the extremities and core muscles in MS patients also affects the sit-to-stand performance negatively as well as a decrease in walking speed and capacity. In this study, it was aimed to investigate the effects of extremity and core muscle strength on walking and sitting-up performance of MS patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2018

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

First Submitted

Initial submission to the registry

July 9, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 24, 2018

Completed
20 days until next milestone

Study Start

First participant enrolled

August 13, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2020

Completed
Last Updated

April 9, 2020

Status Verified

April 1, 2020

Enrollment Period

1.5 years

First QC Date

July 9, 2018

Last Update Submit

April 7, 2020

Conditions

Keywords

strengthwalkingsit-to-stand

Outcome Measures

Primary Outcomes (1)

  • strength of extremity muscles

    The isometric strength of lower extremity muscles will be assessed respectively using a hand-held dynamometer (Baseline®, White Plains, New York, USA).

    baseline

Secondary Outcomes (7)

  • 6 minutes walking test

    baseline

  • timed up and go test

    baseline

  • sit-to-stand test

    baseline

  • Side Bridge Test (core muscles endurance)

    baseline

  • Modified Biering-Sorensen test (core muscles endurance)

    baseline

  • +2 more secondary outcomes

Study Arms (2)

Multiple sclerosis

Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS)

Control

Healthy individuals of similar age and sex to patients

Eligibility Criteria

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

MS patients who are ambulatory

You may qualify if:

  • Participants who 18-65 years of age
  • MS patients who are ambulatory (Expanded Disability Status Scale score ≤ 5,5 ) in a stable phase of the disease, without relapses in the last 3 month.

You may not qualify if:

  • Participants who have orthopedic, vision, hearing, or perception problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

Related Publications (5)

  • Yahia A, Ghroubi S, Mhiri C, Elleuch MH. Relationship between muscular strength, gait and postural parameters in multiple sclerosis. Ann Phys Rehabil Med. 2011 May;54(3):144-55. doi: 10.1016/j.rehab.2011.02.004. Epub 2011 Mar 9. English, French.

    PMID: 21493176BACKGROUND
  • Broekmans T, Gijbels D, Eijnde BO, Alders G, Lamers I, Roelants M, Feys P. The relationship between upper leg muscle strength and walking capacity in persons with multiple sclerosis. Mult Scler. 2013 Jan;19(1):112-9. doi: 10.1177/1352458512444497. Epub 2012 May 4.

    PMID: 22562952BACKGROUND
  • Ketelhut NB, Kindred JH, Manago MM, Hebert JR, Rudroff T. Core muscle characteristics during walking of patients with multiple sclerosis. J Rehabil Res Dev. 2015;52(6):713-24. doi: 10.1682/JRRD.2015.01.0006.

    PMID: 26562753BACKGROUND
  • Fry DK, Huang M, Rodda BJ. Core muscle strength and endurance measures in ambulatory persons with multiple sclerosis: validity and reliability. Int J Rehabil Res. 2015 Sep;38(3):206-12. doi: 10.1097/MRR.0000000000000109.

    PMID: 25647356BACKGROUND
  • Bliss LS, Teeple P. Core stability: the centerpiece of any training program. Curr Sports Med Rep. 2005 Jun;4(3):179-83. doi: 10.1007/s11932-005-0064-y.

    PMID: 15907272BACKGROUND

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

  • Cagla Ozkul

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 9, 2018

First Posted

July 24, 2018

Study Start

August 13, 2018

Primary Completion

February 28, 2020

Study Completion

March 6, 2020

Last Updated

April 9, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations