Feasability, Validty and Reliability of Inertial Sensors

Not Applicable

Completed

• Conditions: Multiple Sclerosis; CVA
• Interventions: Other: IMUs (Xsens, MVN Studio)

• Registration Number: NCT03668990
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-14
• Study Start: 2017-10-01
• Primary Completion: 2018-05-31
• Study Completion: 2018-05-31
• Study First Submitted QC: 2018-09-11
• Study First Posted: 2018-09-13
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-08
• Last Update Posted: 2018-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
persons with Multiple Sclerosis (MS)	IMUs (Xsens, MVN Studio)	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.
Healthy controls	IMUs (Xsens, MVN Studio)	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.
stroke patients	IMUs (Xsens, MVN Studio)	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.

Primary Outcome Measures

Name	Time	Method
kinematic parameter	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

Name	Time	Method
Action Research arm test	Day 1	which assessed the patient's ability to handle objects varying in size
Trunk Impairment Scale	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.
The Brunnström Fugl Meyer (BFM)	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
Manual Ability Measure-36 (questionnaire)	day1	Perceived performance on activity level

Trial Locations

Locations (2)

Jessa Ziekenhuis; 🇧🇪 Hasselt, Belgium

Revalidatie & MS Centrum Overpelt; 🇧🇪 Overpelt, Belgium