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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05503628
Enrollment
60
Registered
2022-08-16
Start date
2022-08-15
Completion date
2023-01-01
Last updated
2022-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis, Trunk control, Balance, Outcome measure

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.

Interventions

None listed

Sponsors

Nord University
CollaboratorOTHER
Helse Nord
CollaboratorINDUSTRY
Nordlandssykehuset HF
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
The modified Trunk Impairment Scale - Norwegian version (TIS-modNV)01 January 2023TIS-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.
AMTI AccuGait OptimizedTM (Advanced Mechanical technology, Inc., Watertown, USA) multi-axis force plate system01 January 2023Force- platform assessing different domains of balance (ie. centre of pressure, sway) in bi- and unipedal standing with eyes open and with eyes closed.

Other

MeasureTime frameDescription
The Mini Balance Evaluation Systems Test (Mini-BESTest)01 January 2023Mini-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.
Expanded Disability Status Scale (EDSS)01 January 2023EDSS 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).

Countries

Norway

Contacts

Primary ContactEllen Christin Arntzen, PHD
ellen.c.arntzen@nord.no+47 91736886
Backup ContactStine Susanne Haakonsen Dahl, MSc
stine.s.dahl@nord.no+4740473368

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026