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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05503628
• Other study ID #: Trunk & balance tests in MS
• Secondary ID: HNF1608-21
• Status: Not yet recruiting
• Start date: August 15, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: August 2022
• Source: Nordlandssykehuset HF
• Contact: Ellen Christin Arntzen, PHD
• Phone: +47 91736886
• Email: ellen.c.arntzen[@]nord.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
Norway	Nordland Hospital Trust	Bodø

Sponsors (3)

Lead Sponsor	Collaborator
Nordlandssykehuset HF	Helse Nord, Nord University

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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
Primary	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