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CompletedNCT03668990Updated Dec 11, 2018

Feasability, Validty and Reliability of Inertial Sensors

An interventional study of IMUs (Xsens, MVN Studio) in Multiple Sclerosis and CVA, sponsored by Hasselt University. Completed at 2 sites in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-11.

Sponsored by Hasselt University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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
  3. 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.

02

Conditions studied

  • Multiple Sclerosis
  • CVA

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03

In context

Multiple Sclerosis

3,524 studies on the registry are indexed under Multiple Sclerosis; 668 are open to participants now.

This study's enrollment of 18 is below the median of 50 across 2,386 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Hasselt University is the lead sponsor of 203 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

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).

Inclusion criteria for PwMS:

- Diagnosed with MS using McDonald criteria (17)

Inclusion criteria Stroke patients

  • First- ever single, unilateral (ischemic or hemorrhagic)
  • At least one month after stroke
  • No apraxia or hemi spatial neglect

Exclusion Criteria:

Exclusion Criteria for pwMS only:

  • a relapse 3 months before the start of the study
  • A change of symptomatic medication during the testing period

Exclusion Criteria:

- People with predominantly ataxia or tremor are excluded from the reliability part of this study

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Other
    persons with Multiple Sclerosis (MS)

    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.

    Other: IMUs (Xsens, MVN Studio)

  • Other
    stroke patients

    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.

    Other: IMUs (Xsens, MVN Studio)

  • Other
    Healthy controls

    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.

    Other: IMUs (Xsens, MVN Studio)

Interventions

  • OtherIMUs (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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: day 2

  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.

    Time frame: day 3

Secondary outcomes

  1. 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

    Time frame: day 1

  2. Action Research arm test

    which assessed the patient's ability to handle objects varying in size

    Time frame: Day 1

  3. 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.

    Time frame: day 1

  4. Manual Ability Measure-36 (questionnaire)

    Perceived performance on activity level

    Time frame: day1

07

Study locations

2 sites
  • Jessa Ziekenhuis
    Hasselt, B-3500, Belgium
  • Revalidatie & MS Centrum Overpelt
    Overpelt, 3900, Belgium
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03668990
Lead sponsor
Hasselt University
Collaborators
Revalidatie & MS Centrum Overpelt, Jessa Hospital
Responsible party
Peter Feys (Principal Investigator, Hasselt University) — Principal investigator
First posted
Sep 13, 2018
Start date
Oct 1, 2017
Primary completion
May 31, 2018
Completion
May 31, 2018
Last update
Dec 11, 2018

Study contacts

peter Feys, prof. dr.
principal investigator · Hasselt University
Joke Raats, drs
study chair · Hasselt University
Liesbet De Baets, dr.
study chair · Hasselt University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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