Feasability, Validty and Reliability of Inertial Sensors

• ClinicalTrials.gov Identifier: NCT03668990
• Recruitment Status: Completed
• First Posted: September 13, 2018
• Last Update Posted: December 11, 2018
• Sponsor: Hasselt University
• Collaborators: Revalidatie & MS Centrum Overpelt; Jessa Hospital
• Information provided by (Responsible Party): Peter Feys, Hasselt University

Study Description

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Principal Investigator: peter Feys, prof. dr.; Hasselt University
• Study Chair: Joke Raats, drs; Hasselt University
• Study Chair: Liesbet De Baets, dr.; Hasselt University

More Information

• Responsible Party: Peter Feys, Principal Investigator, Hasselt University
• ClinicalTrials.gov Identifier: NCT03668990
• Other Study ID Numbers: Kinematic01
• First Posted: September 13, 2018
• Last Update Posted: December 11, 2018
• Last Verified: December 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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