Multiple SclerosisNCT03668990

Feasability, Validty and Reliability of Inertial Sensors

A study testing IMUs (Xsens, MVN Studio) in people with Multiple Sclerosis and CVA, run by Hasselt University at 2 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study has 3 aimes: 1. To investigate the feasibility of using IMUs (Xsens, MVN Studio) during functional tasks to assess upper limb kinematics in pwMS and stroke survivors. On the one hand, the feasibility of performing the tasks will be investigated . On the other hand, does the XSens give valuable data? 2. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Multiple Sclerosis, CVA
What is being tested?: IMUs (Xsens, MVN Studio)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 2 sitesBelgium
Study dates: 1 Oct 2017to 31 May 2018
Phase: Interventional
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Inclusion criteria for all participants: Healthy controls, pwsMS and stroke patients
No orthopedic or neuro-muscular impairments in the upper limb
Age > 18 years
Able to understand and execute the test instructions
Perceived pain in one of the upper limbs of more than 4/10 (Visual Analog Scale)
Able to move a joint (wrist, elbow or shoulder) in the upper limb against gravity without resistance (Medical Research Council) (16).

Show all 10Show fewer

Diagnosed with MS using McDonald criteria (17)
First- ever single, unilateral (ischemic or hemorrhagic)
At least one month after stroke
No apraxia or hemi spatial neglect

Who cannot join

a relapse 3 months before the start of the study
A change of symptomatic medication during the testing period
People with predominantly ataxia or tremor are excluded from the reliability part of this study

Trial locations and contacts

2 sites in 1 country.

Belgium2 sites

Jessa Ziekenhuis
Hasselt, B-3500
Revalidatie & MS Centrum Overpelt
Overpelt, 3900

Other trials in Belgium

About this study

Official title: Feasibility, Validity and Reliability Kinematic Movement Analysis of Upper Limb Movements in Stroke and MS Patients Using Inertial Sensors

This study has 3 aimes:

To investigate the feasibility of using IMUs (Xsens, MVN Studio) during functional tasks to assess upper limb kinematics in pwMS and stroke survivors. On the one hand, the feasibility of performing the tasks will be investigated . On the other hand, does the XSens give valuable data?
To investigate the discriminative validity of kinematic measurements of upper limb movements post-stroke and pwMS in comparison with gender and age-matched healthy controls
To investigate the test-retest reliability of the kinematic parameters collected during the different functional tasks in pwMS and stroke survivors

It is a cross-sectional case-controlled observational study, with 3 different groups: 25 Persons with Multiple sclerosis, 25 stroke patients and 50 healthy controls, matched by age and gender.

Conditions: Multiple Sclerosis, CVA
Being tested: IMUs (Xsens, MVN Studio)
Medical subject headings: Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IMUs (Xsens, MVN Studio)Other
It is a full-body human measurement system based on inertial sensors, biomechanical models and sensor fusion algorithms applied in neurological patients for measuring upper limb movements.

Study groups in NCT03668990
Study group	Role	What they receive
persons with Multiple Sclerosis (MS)	Other	25 persons with MS Persons perform funtional-oriented upper limb movments while wearing IMUs (Xsens, MVN Studio). This is a full-body human measurement system based on inertial sensors, biomechanical models and sensor fusion algorithms applied in neurological patients for measuring upper limb movements. Funcitonal-oriented upper limb movements are performed at two different test days. Receives: Other: IMUs (Xsens, MVN Studio)
stroke patients	Other	25 stroke patients Persons perform funtional-oriented upper limb movments while wearing IMUs (Xsens, MVN Studio). This is a full-body human measurement system based on inertial sensors, biomechanical models and sensor fusion algorithms applied in neurological patients for measuring upper limb movements. Funcitonal-oriented upper limb movements are performed at two different test days. Receives: Other: IMUs (Xsens, MVN Studio)
Healthy controls	Other	50 healthy controls Persons perform funtional-oriented upper limb movments while wearing IMUs (Xsens, MVN Studio). This is a full-body human measurement system based on inertial sensors, biomechanical models and sensor fusion algorithms applied in neurological patients for measuring upper limb movements. Funcitonal-oriented upper limb movements are performed at two different test days. Receives: Other: IMUs (Xsens, MVN Studio)

What is being measured

The primary outcome is the main question the study is designed to answer.

kinematic parameter
The data received of the IMU's are the angles of point task achievement (PTA). PTA is defined as the instant when the ROM, needed for successful task execution, was achieved. Different joint angles of PTA will be calculated by MVN BIOMECH software. Matlab (software version R2016b) and excel will be used to process the data.
Measured: day 2
kinematic parameter
The data received of the IMU's are the angles of point task achievement (PTA). PTA is defined as the instant when the ROM, needed for successful task execution, was achieved. Different joint angles of PTA will be calculated by MVN BIOMECH software. Matlab (software version R2016b) and excel will be used to process the data.
Measured: day 3

Secondary outcomes (4)

The Brunnström Fugl Meyer (BFM)
The Brunnström Fugl Meyer (BFM) was used to measure motor control at the body functions and structures level. The upper limb section is applied: shoulder, elbow, forearm, wrist movements and grip
Measured: day 1
Action Research arm test
which assessed the patient's ability to handle objects varying in size
Measured: Day 1
Trunk Impairment Scale
To examine the clinimetric characteristics of the Trunk Impairment Scale (TIS). This scale evaluates motor impairment of the trunk after stroke. The TIS scores, on a range from 0 to 23, static and dynamic sitting balance as well as trunk co-ordination. It also aims to score the quality of trunk movement and to be a guide for treatment.
Measured: day 1
Manual Ability Measure-36 (questionnaire)
Perceived performance on activity level
Measured: day1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 201731 May 2018

First posted13 Sep 2018
Study start1 Oct 2017
Primary completion31 May 2018
Study completion31 May 2018

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: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03668990
Sponsor's protocol ID: Kinematic01
Status last verified: Dec 2018
First submitted: 14 Sep 2017
Last updated: 11 Dec 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Multiple Sclerosis trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility, Validity and Reliability Kinematic Movement Analysis of Upper Limb Movements in Stroke and MS Patients Using Inertial Sensors
ClinicalTrials.gov ID: NCT03668990
Acronym / sponsor ID: Kinematic01
Conditions: Multiple Sclerosis, CVA
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Hasselt UniversityUniversity, hospital or other
Collaborators: Revalidatie & MS Centrum Overpelt, Jessa Hospital
Study start: 1 Oct 2017 (actual)
Primary completion: 31 May 2018 (actual)
Study completion: 31 May 2018 (actual)
First posted: 13 Sep 2018 (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.

This study has 3 aimes:

To investigate the feasibility of using IMUs (Xsens, MVN Studio) during functional tasks to assess upper limb kinematics in pwMS and stroke survivors. On the one hand, the feasibility of performing the tasks will be investigated . On the other hand, does the XSens give valuable data?
To investigate the discriminative validity of kinematic measurements of upper limb movements post-stroke and pwMS in comparison with gender and age-matched healthy controls
To investigate the test-retest reliability of the kinematic parameters collected during the different functional tasks in pwMS and stroke survivors

It is a cross-sectional case-controlled observational study, with 3 different groups: 25 Persons with Multiple sclerosis, 25 stroke patients and 50 healthy controls, matched by age and gender.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
persons with Multiple Sclerosis (MS)	Other	Other: IMUs (Xsens, MVN Studio)25 persons with MS Persons perform funtional-oriented upper limb movments while wearing IMUs (Xsens, MVN Studio). This is a full-body human measurement system based on inertial sensors, biomechanical models and sensor fusion algorithms applied in neurological patients for measuring upper limb movements. Funcitonal-oriented upper limb movements are performed at two different test days.
stroke patients	Other	Other: IMUs (Xsens, MVN Studio)25 stroke patients Persons perform funtional-oriented upper limb movments while wearing IMUs (Xsens, MVN Studio). This is a full-body human measurement system based on inertial sensors, biomechanical models and sensor fusion algorithms applied in neurological patients for measuring upper limb movements. Funcitonal-oriented upper limb movements are performed at two different test days.
Healthy controls	Other	Other: IMUs (Xsens, MVN Studio)50 healthy controls Persons perform funtional-oriented upper limb movments while wearing IMUs (Xsens, MVN Studio). This is a full-body human measurement system based on inertial sensors, biomechanical models and sensor fusion algorithms applied in neurological patients for measuring upper limb movements. Funcitonal-oriented upper limb movements are performed at two different test days.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Inclusion criteria for all participants: Healthy controls, pwsMS and stroke patients
No orthopedic or neuro-muscular impairments in the upper limb
Age > 18 years
Able to understand and execute the test instructions
Perceived pain in one of the upper limbs of more than 4/10 (Visual Analog Scale)

Key exclusion criteria (3 listed)

a relapse 3 months before the start of the study
A change of symptomatic medication during the testing period
People with predominantly ataxia or tremor are excluded from the reliability part of this study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IMUs (Xsens, MVN Studio)It is a full-body human measurement system based on inertial sensors, biomechanical models and sensor fusion algorithms applied in neurological patients for measuring upper limb movements.	Other	Healthy controls, persons with Multiple Sclerosis (MS), stroke patients

Primary outcome

kinematic parameter
Time frame: day 2
The data received of the IMU's are the angles of point task achievement (PTA). PTA is defined as the instant when the ROM, needed for successful task execution, was achieved. Different joint angles of PTA will be calculated by MVN BIOMECH software. Matlab (software version R2016b) and excel will be used to process the data.
kinematic parameter
Time frame: day 3
The data received of the IMU's are the angles of point task achievement (PTA). PTA is defined as the instant when the ROM, needed for successful task execution, was achieved. Different joint angles of PTA will be calculated by MVN BIOMECH software. Matlab (software version R2016b) and excel will be used to process the data.

4 secondary outcomes

The Brunnström Fugl Meyer (BFM)
Time frame: day 1
Action Research arm test
Time frame: Day 1
Trunk Impairment Scale
Time frame: day 1
Manual Ability Measure-36 (questionnaire)
Time frame: day1

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
Individual participant dataSharing planned: Undecided

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Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
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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.

peter Feys, prof. dr. principal investigator

Hasselt University

Joke Raats, drs study chair

Hasselt University

Liesbet De Baets, dr. study chair

Hasselt University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing IMUs (Xsens, MVN Studio) in people with Multiple Sclerosis and CVA, run by Hasselt University at 2 sites in Belgium.

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 10 inclusion and 3 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: finished, as of the sponsor's last update on 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

kinematic parameter (time frame: day 2). 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?

On the ClinicalTrials.gov record for NCT03668990.

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 11 Dec 2018.