Clinical trial NCT03668990: 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
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
CVA
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Revalidatie & MS Centrum Overpelt
name: Jessa Hospital
First posted: 2018-09-13
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: kinematic parameter
timeFrame: day 2
measure: kinematic parameter
timeFrame: day 3
Secondary outcomes:
measure: The Brunnström Fugl Meyer (BFM)
timeFrame: day 1
measure: Action Research arm test
timeFrame: Day 1
measure: Trunk Impairment Scale
timeFrame: day 1
measure: Manual Ability Measure-36 (questionnaire)
timeFrame: day1
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Overpelt
country: Belgium
facility: Revalidatie & MS Centrum Overpelt
Study officials:
affiliation: Hasselt University
name: peter Feys, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Joke Raats, drs
role: STUDY_CHAIR
affiliation: Hasselt University
name: Liesbet De Baets, dr.
role: STUDY_CHAIR
References: