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

NCT ID: NCT05503628

Last Updated: 2022-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-15

Study Completion Date

2023-01-01

Brief Summary

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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

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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.

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nord University

OTHER

Sponsor Role collaborator

Helse Nord

INDUSTRY

Sponsor Role collaborator

Nordlandssykehuset HF

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Petter Øyen, PHD

Role: STUDY_DIRECTOR

Nordlandssykehuset HF

Locations

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Nordland Hospital Trust

Bodø, , Norway

Site Status

Countries

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Norway

Central Contacts

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Ellen Christin Arntzen, PHD

Role: CONTACT

+47 91736886

Stine Susanne Haakonsen Dahl, MSc

Role: CONTACT

+4740473368

Facility Contacts

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Ellen Christin Arntzen, PHD

Role: primary

+4791736886

Stine Susanne Haakonsen Dahl, MSc

Role: backup

+47 40473368

Other Identifiers

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HNF1608-21

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Trunk & balance tests in MS

Identifier Type: -

Identifier Source: org_study_id

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