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

Sponsor
Nordlandssykehuset HF (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05503628
Collaborator
Nord University (Other), Helse Nord (Industry)
60
1
4.6
13.1

Study Details

Study Description

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 Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated 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
    Anticipated Study Start Date :
    Aug 15, 2022
    Anticipated Primary Completion Date :
    Jan 1, 2023
    Anticipated Study Completion Date :
    Jan 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. The modified Trunk Impairment Scale - Norwegian version (TIS-modNV) [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 [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) [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) [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nordland Hospital Trust Bodø Norway 8000

    Sponsors and Collaborators

    • Nordlandssykehuset HF
    • Nord University
    • Helse Nord

    Investigators

    • Study Director: Petter Øyen, PHD, Nordlandssykehuset HF

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nordlandssykehuset HF
    ClinicalTrials.gov Identifier:
    NCT05503628
    Other Study ID Numbers:
    • Trunk & balance tests in MS
    • HNF1608-21
    First Posted:
    Aug 16, 2022
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nordlandssykehuset HF
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 19, 2022