Multiple SclerosisNCT05503628
A Measurement Study of TIS-modNV and AccuGait Force Platform in People With MS
An observational study of Multiple Sclerosis, run by Nordlandssykehuset HF at 1 site in Norway.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- 15 Aug 2022to 1 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- MS diagnosis (McDonalds criteria)
- EDSS= 0-6.5
- Ability to walk minimum 6 meters
Who cannot join
- People will be excluded if not being able to follow test instructions
Trial locations and contacts
1 site in 1 country.
Norway1 site
Nordland Hospital Trust
Bodø, 8000
Ellen Christin Arntzen, PHD, +4791736886, ellen.c.arntzen@nord.no
Stine Susanne Haakonsen Dahl, MSc, +47 40473368, stine.s.dahl@nord.no
About this study
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
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.
Read the 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:
- 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.
- 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
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Trunk control, Balance, Outcome measure
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 01 January 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start15 Aug 2022 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordlandssykehuset HF
- Sponsor type
- University, hospital or other
- Collaborators
- Nord University, Helse Nord
- Responsible party
- Sponsor
- Investigators
- Petter Øyen, PHD, Study director, Nordlandssykehuset HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503628
- Sponsor's protocol ID
- Trunk & balance tests in MS
- Other IDs
- HNF1608-21
- Status last verified
- Aug 2022
- First submitted
- 15 Aug 2022
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05503628
- Acronym / sponsor ID
- Trunk & balance tests in MS
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Trunk control, Balance, Outcome measure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nordlandssykehuset HFUniversity, hospital or other
- Collaborators
- Nord University, Helse Nord
- Study start
- 15 Aug 2022 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 16 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- MS diagnosis (McDonalds criteria)
- EDSS= 0-6.5
- Ability to walk minimum 6 meters
Key exclusion criteria (1 listed)
- People will be excluded if not being able to follow test instructions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The modified Trunk Impairment Scale - Norwegian version (TIS-modNV)
Time frame: 01 January 2023
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.
AMTI AccuGait OptimizedTM (Advanced Mechanical technology, Inc., Watertown, USA) multi-axis force plate system
Time frame: 01 January 2023
Force- platform assessing different domains of balance (ie. centre of pressure, sway) in bi- and unipedal standing with eyes open and with eyes closed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petter Øyen, PHD study director
Nordlandssykehuset HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Nordlandssykehuset HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ellen Christin Arntzen, PHD (+47 91736886, ellen.c.arntzen@nord.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The modified Trunk Impairment Scale - Norwegian version (TIS-modNV) (time frame: 01 January 2023). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2022; AzTrials last refreshed its copy on 6 Nov 2026.