NCT04182269

Brief Summary

Patients with Multiple Sclerosis (MS) have reduced functional capacity due to clinical symptoms of the disease, resulting in decreased participation in daily living activities and reduced quality of life. Evaluation of functional capacity and activities of daily living is very important in order to determine appropriate rehabilitation programs and increase the participation of patients in daily life activities. However, although there are many scales evaluating functional capacity and activities of daily living in people with disabilities, there is no specific assessment scale specific to MS patients. Therefore, this study was planned to investigate whether the Glittre Daily Living Activities (ADL) Test, which was developed to measure functional capacity in chronic obstructive pulmonary disease, is a valid and reliable measurement tool in MS patients. For this purpose, a total of 51 participants (25 MS patients and 26 healthy participants) evaluated with Glittre ADL Test. The relationship between Glittre ADL Test and 6-minute walk test, Notthingham Extended Daily Living Activities Index, Multiple Sclerosis Quality of Life Scale, Fatigue Severity Scale, Balance Assessment Systems Test (MiniBEST Test), Extended Disability Status Scale and 5-repetition sit-to-stand test evaluated with Pearson or Spearman correlation coefficient. For the known group validity, the difference between the patient and control groups compared with the test of the difference between the two means. For reliability, test retest performed. Reliability evaluated with the intraclass correlation coefficient. Hypothesis 1: Glittre ADL Test results in MS patients and healthy subjects are different. Hypothesis 2: Glittre ADL Test is reliable in MS patients. Hypothesis 3: Glittre ADL Test is valid for evaluating functional exercise capacity in MS patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 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

Study Start

First participant enrolled

October 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 26, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 2, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2020

Completed
Last Updated

February 12, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

November 26, 2019

Last Update Submit

February 9, 2021

Conditions

Keywords

Multiple sclerosisGlittre ADL testFunctional capacity assesment

Outcome Measures

Primary Outcomes (1)

  • Glittre Activities of Dailiy Living Test

    Functional exercise capacity measurement

    10 minute

Secondary Outcomes (7)

  • 6 minute walk test (6MWT)

    10 minute

  • Nottingham Extended Daily Living Activities Index (NGGYAI)

    10 minute

  • Extended Disability Status Scale (EDSS)

    minimum 30 minute

  • Fatigue Severity Scale

    10 minute

  • Multiple Sclerosis Quality of Life İnstrument - 54 (MSQOL-54)

    15 minute

  • +2 more secondary outcomes

Study Arms (2)

Study Group

Multiple Sclerosis Patients

Other: Measurement of functional exercise capacity

Control Group

Healthy Subjects

Other: Measurement of functional exercise capacity

Interventions

The Glittre Activities of Daily Living (ADL) Test was used to evaluate functional exercise capacity.

Control GroupStudy Group

Eligibility Criteria

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

Volunteers of the patients who applied to Hacettepe University Neurology Department, diagnosed with MS by specialist physician and referred to Hacettepe University Faculty of Health Sciences Physiotherapy and Rehabilitation Department for physiotherapy and rehabilitation program were included in the study.

You may qualify if:

  • Between 18-65 years
  • Relapsing Remitting Multiple Sclerosis (RRMS) type MS disease.
  • Extended Disability Status Scale (EDSS) score of maximum 4.5
  • No attacks during the last 3 months
  • The medication has not been changed in the last 6 months.
  • Getting more than 24 points from the Standardized Mini Mental Test.

You may not qualify if:

  • Having had any musculoskeletal surgery.
  • Using a walking aid or orthosis.
  • Having a neurological disease other than MS.
  • Having orthopedic or rheumatological problems that will affect function.
  • Having a peripheral vestibular problem.
  • Having a cardiovascular and pulmonary disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Related Publications (16)

  • Langeskov-Christensen M, Heine M, Kwakkel G, Dalgas U. Aerobic capacity in persons with multiple sclerosis: a systematic review and meta-analysis. Sports Med. 2015 Jun;45(6):905-23. doi: 10.1007/s40279-015-0307-x.

    PMID: 25739555BACKGROUND
  • Skumlien S, Hagelund T, Bjortuft O, Ryg MS. A field test of functional status as performance of activities of daily living in COPD patients. Respir Med. 2006 Feb;100(2):316-23. doi: 10.1016/j.rmed.2005.04.022. Epub 2005 Jun 6.

    PMID: 15941658BACKGROUND
  • Savci S, Inal-Ince D, Arikan H, Guclu-Gunduz A, Cetisli-Korkmaz N, Armutlu K, Karabudak R. Six-minute walk distance as a measure of functional exercise capacity in multiple sclerosis. Disabil Rehabil. 2005 Nov 30;27(22):1365-71. doi: 10.1080/09638280500164479.

    PMID: 16372431BACKGROUND
  • Nicholl CR, Lincoln NB, Playford ED. The reliability and validity of the Nottingham Extended Activities of Daily Living Scale in patients with multiple sclerosis. Mult Scler. 2002 Oct;8(5):372-6. doi: 10.1191/1352458502ms827oa.

    PMID: 12356202BACKGROUND
  • Sahin F, Yilmaz F, Ozmaden A, Kotevoglu N, Sahin T, Kuran B. Reliability and validity of the Turkish version of the Nottingham Extended Activities of Daily Living Scale. Aging Clin Exp Res. 2008 Oct;20(5):400-5. doi: 10.1007/BF03325144.

    PMID: 19039280BACKGROUND
  • Moller AB, Bibby BM, Skjerbaek AG, Jensen E, Sorensen H, Stenager E, Dalgas U. Validity and variability of the 5-repetition sit-to-stand test in patients with multiple sclerosis. Disabil Rehabil. 2012;34(26):2251-8. doi: 10.3109/09638288.2012.683479. Epub 2012 May 22.

    PMID: 22612360BACKGROUND
  • Armutlu K, Korkmaz NC, Keser I, Sumbuloglu V, Akbiyik DI, Guney Z, Karabudak R. The validity and reliability of the Fatigue Severity Scale in Turkish multiple sclerosis patients. Int J Rehabil Res. 2007 Mar;30(1):81-5. doi: 10.1097/MRR.0b013e3280146ec4.

    PMID: 17293726BACKGROUND
  • Idiman E, Uzunel F, Ozakbas S, Yozbatiran N, Oguz M, Callioglu B, Gokce N, Bahar Z. Cross-cultural adaptation and validation of multiple sclerosis quality of life questionnaire (MSQOL-54) in a Turkish multiple sclerosis sample. J Neurol Sci. 2006 Jan 15;240(1-2):77-80. doi: 10.1016/j.jns.2005.09.009. Epub 2005 Nov 8.

    PMID: 16277993BACKGROUND
  • Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444.

    PMID: 6685237BACKGROUND
  • Cameron M, Mazumder R, Murchison C, King L. Mini Balance Evaluation Systems Test in people with multiple sclerosis: reflects imbalance but may not predict falls. Gait Posture. 2014;39(1):669. doi: 10.1016/j.gaitpost.2013.08.009. Epub 2013 Oct 17. No abstract available.

    PMID: 24184138BACKGROUND
  • Compston A, Coles A. Multiple sclerosis. Lancet. 2008 Oct 25;372(9648):1502-17. doi: 10.1016/S0140-6736(08)61620-7.

    PMID: 18970977BACKGROUND
  • Mansson E, Lexell J. Performance of activities of daily living in multiple sclerosis. Disabil Rehabil. 2004 May 20;26(10):576-85. doi: 10.1080/09638280410001684587.

    PMID: 15204511BACKGROUND
  • Marrie RA, Hanwell H. General health issues in multiple sclerosis: comorbidities, secondary conditions, and health behaviors. Continuum (Minneap Minn). 2013 Aug;19(4 Multiple Sclerosis):1046-57. doi: 10.1212/01.CON.0000433284.07844.6b.

    PMID: 23917100BACKGROUND
  • Stickland MK, Butcher SJ, Marciniuk DD, Bhutani M. Assessing exercise limitation using cardiopulmonary exercise testing. Pulm Med. 2012;2012:824091. doi: 10.1155/2012/824091. Epub 2012 Nov 19.

    PMID: 23213518BACKGROUND
  • Karloh M, Araujo CL, Gulart AA, Reis CM, Steidle LJ, Mayer AF. The Glittre-ADL test reflects functional performance measured by physical activities of daily living in patients with chronic obstructive pulmonary disease. Braz J Phys Ther. 2016 Apr 8;20(3):223-30. doi: 10.1590/bjpt-rbf.2014.0155.

    PMID: 27437713BACKGROUND
  • Kaya G, Kose N, Salci Y, Armutlu K, Karakaya J, Tuncer A, Karabudak R. Reliability and validity of the glittre activities of daily living test in fully ambulatory multiple sclerosis patients. Ir J Med Sci. 2023 Oct;192(5):2379-2386. doi: 10.1007/s11845-022-03237-x. Epub 2022 Dec 1.

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

  • Nezire KÖSE, Prof.

    Hacettepe University

    PRINCIPAL INVESTIGATOR
  • Rana KARABUDAK, Prof.

    Hacettepe University

    STUDY CHAIR
  • Meryem A TUNCER, Prof.

    Haceetepe University

    STUDY CHAIR
  • Kadriye ARMUTLU, Prof.

    Hacettepe University

    PRINCIPAL INVESTIGATOR
  • Yeliz SALCI, Asts. Prof.

    Hacettepe University

    PRINCIPAL INVESTIGATOR
  • Jale KARAKAYA, Assoc. Prof.

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
5 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

November 26, 2019

First Posted

December 2, 2019

Study Start

October 1, 2018

Primary Completion

October 15, 2019

Study Completion

August 4, 2020

Last Updated

February 12, 2021

Record last verified: 2021-02

Locations