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
2 other identifiers
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2022
CompletedStudy Start
First participant enrolled
August 15, 2022
CompletedFirst Posted
Study publicly available on registry
August 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedAugust 19, 2022
August 1, 2022
5 months
August 15, 2022
August 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
The Mini Balance Evaluation Systems Test (Mini-BESTest)
01 January 2023
Expanded Disability Status Scale (EDSS)
01 January 2023
Eligibility Criteria
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.
You may qualify if:
- MS diagnosis (McDonalds criteria)
- EDSS= 0-6.5
- Ability to walk minimum 6 meters
You may not qualify if:
- People will be excluded if not being able to follow test instructions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nordlandssykehuset HFlead
- Nord Universitycollaborator
- Helse Nordcollaborator
Study Sites (1)
Nordland Hospital Trust
Bodø, 8000, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Petter Øyen, PHD
Nordlandssykehuset HF
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2022
First Posted
August 16, 2022
Study Start
August 15, 2022
Primary Completion
January 1, 2023
Study Completion
January 1, 2023
Last Updated
August 19, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share