Skip to main content
OpenTrials
Completed

NCT Number: NCT05205824

Validation IMU and EMG Algorithms in Stroke Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roessingh Research and Development

Enschede, 7522AH, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

algorithm validation

Other

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

Primary outcomes

  1. Inertial measurement unit data

    Time frame: 1-2 hours

    Activity data of the sensors attached to various body parts

Secondary outcomes

  1. surface EMG-data

    Time frame: 1-2 hours

    rectus femoris/vastus lateralis/gastrocnemius/soleus data

Other outcomes

  1. anonymized video data

    Time frame: 1-2 hours

    Video data of the measurements performed

  2. Age

    Time frame: at inclusion

    Age (in years)

  3. Height

    Time frame: at inclusion

    Height (in cm)

  4. Leg length

    Time frame: at inclusion

    Leg length (in cm)

  5. Time since stroke

    Time frame: at inclusion

    time since stroke (in years)

  6. Type of stroke

    Time frame: at inclusion

    type of stroke (ischemic or hemorrhagic)

  7. Body side

    Time frame: at inclusion

    Affected and dominant body side (left or right)

  8. FAC-score

    Time frame: at inclusion

    Functional Ambulation Categories score (0-5 points) to assess independence of walking

  9. Motricity Index

    Time frame: at inclusion

    Motricity index lower limb (0-33 points)

Sponsors and collaborators

Lead sponsor

Roessingh Research and Development

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 25, 2022
Registry last updated
Jul 19, 2022

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.