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Feasability, Validty and Reliability of Inertial Sensors

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03668990
Enrollment
18
Registered
2018-09-13
Start date
2017-10-01
Completion date
2018-05-31
Last updated
2018-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CVA, Multiple Sclerosis

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.

Interventions

OTHERIMUs (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.

Sponsors

Revalidatie & MS Centrum Overpelt
CollaboratorOTHER
Jessa Hospital
CollaboratorOTHER
Hasselt University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
kinematic parameterday 2The 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

MeasureTime frameDescription
The Brunnström Fugl Meyer (BFM)day 1The 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
Action Research arm testDay 1which assessed the patient's ability to handle objects varying in size
Trunk Impairment Scaleday 1To 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.
Manual Ability Measure-36 (questionnaire)day1Perceived performance on activity level

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026