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Feasability, Validty and Reliability of Inertial Sensors

Primary Purpose

Multiple Sclerosis, CVA

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
IMUs (Xsens, MVN Studio)
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Jessa Ziekenhuis
  • Revalidatie & MS Centrum Overpelt

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

persons with Multiple Sclerosis (MS)

stroke patients

Healthy controls

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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
Action Research arm test
which assessed the patient's ability to handle objects varying in size
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.
Manual Ability Measure-36 (questionnaire)
Perceived performance on activity level

Full Information

First Posted
September 14, 2017
Last Updated
December 8, 2018
Sponsor
Hasselt University
Collaborators
Revalidatie & MS Centrum Overpelt, Jessa Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03668990
Brief Title
Feasability, Validty and Reliability of Inertial Sensors
Official Title
Feasibility, Validity and Reliability Kinematic Movement Analysis of Upper Limb Movements in Stroke and MS Patients Using Inertial Sensors
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Revalidatie & MS Centrum Overpelt, Jessa Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, CVA

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
persons with Multiple Sclerosis (MS)
Arm Type
Other
Arm Description
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.
Arm Title
stroke patients
Arm Type
Other
Arm Description
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.
Arm Title
Healthy controls
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
IMUs (Xsens, MVN Studio)
Intervention Description
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 Measure Information:
Title
kinematic parameter
Description
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
Title
kinematic parameter
Description
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 Outcome Measure Information:
Title
The Brunnström Fugl Meyer (BFM)
Description
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
Title
Action Research arm test
Description
which assessed the patient's ability to handle objects varying in size
Time Frame
Day 1
Title
Trunk Impairment Scale
Description
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
Title
Manual Ability Measure-36 (questionnaire)
Description
Perceived performance on activity level
Time Frame
day1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
peter Feys, prof. dr.
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joke Raats, drs
Organizational Affiliation
Hasselt University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Liesbet De Baets, dr.
Organizational Affiliation
Hasselt University
Official's Role
Study Chair
Facility Information:
Facility Name
Jessa Ziekenhuis
City
Hasselt
ZIP/Postal Code
B-3500
Country
Belgium
Facility Name
Revalidatie & MS Centrum Overpelt
City
Overpelt
ZIP/Postal Code
3900
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Feasability, Validty and Reliability of Inertial Sensors

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