Feasability, Validty and Reliability of Inertial Sensors

NCT03668990 | Completed

• 1 other identifier: Kinematic01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

This study has 3 aimes:

1. 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. 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. 3.To investigate the test-retest reliability of the kinematic parameters collected during the different functional tasks in pwMS and stroke survivors

Conditions

Multiple Sclerosis; CVA

Outcome Measures

Primary Outcomes (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.

  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.

  day 3

Secondary Outcomes (4)

• The Brunnström Fugl Meyer (BFM)

  day 1

• Action Research arm test

  Day 1

• Trunk Impairment Scale

  day 1

• Manual Ability Measure-36 (questionnaire)

  day1

Study Arms (3)

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.

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.

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.

Other: IMUs (Xsens, MVN Studio)

Interventions

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.

Healthy controls; persons with Multiple Sclerosis (MS); stroke patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasselt University: lead
• Revalidatie & MS Centrum Overpelt: collaborator
• Jessa Hospital: collaborator

Study Sites (2)

Jessa Ziekenhuis

Hasselt, B-3500, Belgium

Location

Revalidatie & MS Centrum Overpelt

Overpelt, 3900, Belgium

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• peter Feys, prof. dr.

  Hasselt University

  PRINCIPAL INVESTIGATOR

• Joke Raats, drs

  Hasselt University

  STUDY CHAIR

• Liesbet De Baets, dr.

  Hasselt University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 13, 2018
• Study Start: October 1, 2017
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: December 11, 2018

Record last verified: 2018-12

Locations

BE (2)