Skip to main content
OpenTrials
Completed

NCT Number: NCT03668990

Feasability, Validty and Reliability of Inertial Sensors

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jessa Ziekenhuis, Hasselt, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • Jessa Hospital
  • Revalidatie & MS Centrum Overpelt

Registry information

Official study title

Feasibility, Validity and Reliability Kinematic Movement Analysis of Upper Limb Movements in Stroke and MS Patients Using Inertial Sensors

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 13, 2018
Registry last updated
Dec 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.