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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Ellen Christin Arntzen, PHD; Phone Number: +47 91736886; Email: ellen.c.arntzen@nord.no
• Study Contact Backup: Name: Stine Susanne Haakonsen Dahl, MSc; Phone Number: +4740473368; Email: stine.s.dahl@nord.no

Study Locations

• Norway
  • Bodø, Norway, 8000
    • Nordland Hospital Trust
    • Contact: Ellen Christin Arntzen, PHD; Phone Number: +4791736886; Email: ellen.c.arntzen@nord.no
    • Contact: Stine Susanne Haakonsen Dahl, MSc; Phone Number: +47 40473368; Email: stine.s.dahl@nord.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Mini Balance Evaluation Systems Test (Mini-BESTest)	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.	01 January 2023
Expanded Disability Status Scale (EDSS)	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).	01 January 2023

Collaborators and Investigators

• Sponsor: Nordlandssykehuset HF
• Collaborators: Helse Nord; Nord University
• Investigators: Study Director: Petter Øyen, PHD, Nordlandssykehuset HF

Study record dates

Study Major Dates

• Study Start (Anticipated): August 15, 2022
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: August 15, 2022
• First Submitted That Met QC Criteria: August 15, 2022
• First Posted (Actual): August 16, 2022

Study Record Updates

• Last Update Posted (Actual): August 19, 2022
• Last Update Submitted That Met QC Criteria: August 17, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Balance; Trunk control; Outcome measure
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: Trunk & balance tests in MS; HNF1608-21 (Other Grant/Funding Number: Northern Norway Regional Health Authoroty)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No