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A Measurement Study of TIS-modNV and AccuGait Force Platform in People With MS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05503628
Recruitment Status : Not yet recruiting
First Posted : August 16, 2022
Last Update Posted : August 19, 2022
Sponsor:
Collaborators:
Nord University
Helse Nord
Information provided by (Responsible Party):
Nordlandssykehuset HF

Brief Summary:
The current project will fill a knowledge gap in the follow-up of people with Multiple Sclerosis (MS) with mild and moderate disability levels, with the purpose to assess the adequacy of measurement tools for trunk control and balance, functions that are pre-requisites for optimal performance in everyday physical activities.

Condition or disease
Multiple Sclerosis

Detailed Description:

Trunk control and balance, necessary for daily activities, are frequently impaired in people with MS. Adequate measurement tools for clinical- and research purposes are thus warranted. In this study two measurement tools will be explored:

  1. The Trunk Impairment scale - modified Norwegian version (TIS-modNV), which has demonstrated high validity and reliability in individuals with stoke (Gjelsvik et al., 2012), however its properties has not yet been assessed in people with MS. Concurrent validity with a balance scale, the Mini-Balance Evaluation Systems Test (Mini-BESTest), will be assessed as well as its inter- and intra-rater reliability.
  2. The AMTI Accugait Optimized™ multi-axis force platform (AMTI, Inc., Newton, MA) will be examined as there is a lack of studies measuring its properties within the MS population. A validity assessment of this tool will be included in this measurement study.

This study is two-parted, each with a separate aim:

Aim part 1: To determine the validity and reliability of the TIS-modNV across mild and moderate disability levels in the MS population.

Aim part 2: To determine the concurrent validity of the AMTI AccuGait OptimizedTM force plate system compared to the Mini-BESTest across mild and moderate disability levels in the MS population.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Validity and Reliability of the Trunk Impairment Scale-modNV and the AMTI AccuGait Optimized Force Platform Across Mild and Moderate Disability Levels in the MS Population
Estimated Study Start Date : August 15, 2022
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. The modified Trunk Impairment Scale - Norwegian version (TIS-modNV) [ Time Frame: 01 January 2023 ]
    TIS-modNV is a six-item ordinal scale measuring impairments of trunk control. The total score ranges between 0-16, where 16 is the best score in trunk control. The scale is developed for and valid and reliable for people with stroke.

  2. AMTI AccuGait OptimizedTM (Advanced Mechanical technology, Inc., Watertown, USA) multi-axis force plate system [ Time Frame: 01 January 2023 ]
    Force- platform assessing different domains of balance (ie. centre of pressure, sway) in bi- and unipedal standing with eyes open and with eyes closed.


Other Outcome Measures:
  1. The Mini Balance Evaluation Systems Test (Mini-BESTest) [ Time Frame: 01 January 2023 ]
    Mini-BESTest is a 14-item ordinal scale, measuring balance in standing and walking. The total scores ranges from 0-28, were 28 is the best score of balance performance. The Norwegian translation of the test is valid and reliable for people with MS.

  2. Expanded Disability Status Scale (EDSS) [ Time Frame: 01 January 2023 ]
    EDSS is a method of quantifying and monitoring disability in people with MS on a scale from 0-10 and is widely used in clinic and research. A total score of 0 describes "no disability" and a score 10 describes "death due to MS". EDSS scores 0-6.5 (the levels included in this study) encompasses individuals with normal neurological exam/fully ambulatory (score 0) to individuals requiring a walking aids (cane, crutch) to walk about 20m without resting (score 6.5).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will be conducted in Bodø, Nordland county, Norway involving the MS population affiliated to the MS-outpatient clinic at Nordland Hospital (NLSH) and whose adress is in one of the eight municipalities in the Salten region. All people in this population, fitting the inclusion criteria will be requested to participate. People covering the whole range of EDSS 0-6.5 will be recruited. If too many people consents to participate there will be draw.
Criteria

Inclusion Criteria:

  • MS diagnosis (McDonalds criteria)
  • EDSS= 0-6.5
  • Ability to walk minimum 6 meters

Exclusion Criteria:

  • People will be excluded if not being able to follow test instructions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05503628


Contacts
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Contact: Ellen Christin Arntzen, PHD +47 91736886 ellen.c.arntzen@nord.no
Contact: Stine Susanne Haakonsen Dahl, MSc +4740473368 stine.s.dahl@nord.no

Locations
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Norway
Nordland Hospital Trust
Bodø, Norway, 8000
Contact: Ellen Christin Arntzen, PHD    +4791736886    ellen.c.arntzen@nord.no   
Contact: Stine Susanne Haakonsen Dahl, MSc    +47 40473368    stine.s.dahl@nord.no   
Sponsors and Collaborators
Nordlandssykehuset HF
Nord University
Helse Nord
Investigators
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Study Director: Petter Øyen, PHD Nordlandssykehuset HF
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Responsible Party: Nordlandssykehuset HF
ClinicalTrials.gov Identifier: NCT05503628    
Other Study ID Numbers: Trunk & balance tests in MS
HNF1608-21 ( Other Grant/Funding Number: Northern Norway Regional Health Authoroty )
First Posted: August 16, 2022    Key Record Dates
Last Update Posted: August 19, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nordlandssykehuset HF:
Multiple Sclerosis
Trunk control
Balance
Outcome measure
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases