Feasability, Validty and Reliability of Inertial Sensors

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03668990
• Other study ID #: Kinematic01
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: December 2018
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• CVA
• Multiple Sclerosis

Intervention

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.

Locations

Country	Name	City	State
Belgium	Jessa Ziekenhuis	Hasselt
Belgium	Revalidatie & MS Centrum Overpelt	Overpelt

Sponsors (3)

Lead Sponsor	Collaborator
Hasselt University	Jessa Hospital, Revalidatie & MS Centrum Overpelt

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	kinematic parameter	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.	day 2
Primary	kinematic parameter	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.	day 3
Secondary	The Brunnström Fugl Meyer (BFM)	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	day 1
Secondary	Action Research arm test	which assessed the patient's ability to handle objects varying in size	Day 1
Secondary	Trunk Impairment Scale	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.	day 1
Secondary	Manual Ability Measure-36 (questionnaire)	Perceived performance on activity level	day1