Clinical trial NCT05503628: A Measurement Study of TIS-modNV and AccuGait Force Platform in People With MS
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Trunk control
Balance
Outcome measure
Lead sponsor: Nordlandssykehuset HF
Sponsor class: OTHER
Collaborators: name: Nord University
name: Helse Nord
First posted: 2022-08-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: The modified Trunk Impairment Scale - Norwegian version (TIS-modNV)
timeFrame: 01 January 2023
measure: AMTI AccuGait OptimizedTM (Advanced Mechanical technology, Inc., Watertown, USA) multi-axis force plate system
timeFrame: 01 January 2023
Secondary outcomes:
Other outcomes:
measure: The Mini Balance Evaluation Systems Test (Mini-BESTest)
timeFrame: 01 January 2023
measure: Expanded Disability Status Scale (EDSS)
timeFrame: 01 January 2023
Locations:
city: Bodø
country: Norway
facility: Nordland Hospital Trust
Study officials:
affiliation: Nordlandssykehuset HF
name: Petter Øyen, PHD
role: STUDY_DIRECTOR
References: