Validation IMU and EMG Algorithms in Stroke Patients

NCT ID: NCT05205824

Last Updated: 2022-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-22

Study Completion Date

2022-05-25

Brief Summary

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The objective is to validate the algorithms for movement analysis that were developed previously in healthy participants, in a small study with stroke patients. Stroke subjects will be measured while performing tasks like walking, sitting and standing while wearing light-weight inertial measurements units (IMUs) incorporating 3D accelerometers, 3D gyroscopes and surface electromyography. During the measurements subjects will be recorded on video that serves as ground truth when validating the implemented algorithms for movement analysis. A face blurring program will be used for all video footage.

Detailed Description

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Subjects will perform the following tasks: 30 sec stationary sitting/standing/lying; 10m walk test; L-test; 8-figure walking test; daily life task; stepping over small obstacles; walk in the corridor. During the measurments IMU will be placed at: sternum; sacrum; bilateral wrists; bilateral shanks; bilateral upper legs; both feet. Surface EMG of bilateral rectus femoris; vastus lateralis; medial gastrocnemius and soleus will be measured.

Conditions

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Algorithm validation

all subjects will be measured with inertial measurement units while performing tasks like walking, standing and sitting.

Group Type OTHER

algorithm validation

Intervention Type OTHER

stroke subjects are measured to validate algorithms previously developed after including healthy subjects

Interventions

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algorithm validation

stroke subjects are measured to validate algorithms previously developed after including healthy subjects

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* min 18 yrs of age; history of previous stroke; unilateral affected;able to walk without supervision (FAC-score min 4);able to perform activities of daily living without assistance (self-reported); written informed consent.

Exclusion Criteria

* subjects with neurological or motor disorders that could interfere with the measurements (other than stroke) or severe deficits in communication, memory and understanding.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roessingh Research and Development

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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C Nikamp, PhD

Role: PRINCIPAL_INVESTIGATOR

Roessingh Research and Development

Locations

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Roessingh Research and Development

Enschede, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2021-8218

Identifier Type: -

Identifier Source: org_study_id

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