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Feasability, Validty and Reliability of Inertial Sensors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03668990
Recruitment Status : Completed
First Posted : September 13, 2018
Last Update Posted : December 11, 2018
Sponsor:
Collaborators:
Revalidatie & MS Centrum Overpelt
Jessa Hospital
Information provided by (Responsible Party):
Peter Feys, Hasselt University

Brief 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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis CVA Other: IMUs (Xsens, MVN Studio) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Feasibility, Validity and Reliability Kinematic Movement Analysis of Upper Limb Movements in Stroke and MS Patients Using Inertial Sensors
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)
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.

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)
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.

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)
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. The Brunnström Fugl Meyer (BFM) [ Time Frame: day 1 ]
    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

  2. Action Research arm test [ Time Frame: Day 1 ]
    which assessed the patient's ability to handle objects varying in size

  3. Trunk Impairment Scale [ Time Frame: day 1 ]
    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.

  4. Manual Ability Measure-36 (questionnaire) [ Time Frame: day1 ]
    Perceived performance on activity level



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668990


Locations
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Belgium
Jessa Ziekenhuis
Hasselt, Belgium, B-3500
Revalidatie & MS Centrum Overpelt
Overpelt, Belgium, 3900
Sponsors and Collaborators
Hasselt University
Revalidatie & MS Centrum Overpelt
Jessa Hospital
Investigators
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Principal Investigator: peter Feys, prof. dr. Hasselt University
Study Chair: Joke Raats, drs Hasselt University
Study Chair: Liesbet De Baets, dr. Hasselt University
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Responsible Party: Peter Feys, Principal Investigator, Hasselt University
ClinicalTrials.gov Identifier: NCT03668990    
Other Study ID Numbers: Kinematic01
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases