Validation IMU and EMG Algorithms in Stroke Patients

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: algorithm validation

• Registration Number: NCT05205824
• Lead Sponsor: Roessingh Research and Development

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-12-21
• Study Start: 2021-12-22
• Study First Submitted QC: 2022-01-12
• Study First Posted: 2022-01-25
• Primary Completion: 2022-05-25
• Study Completion: 2022-05-25
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-15
• Last Update Posted: 2022-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Algorithm validation	algorithm validation	all subjects will be measured with inertial measurement units while performing tasks like walking, standing and sitting.

Primary Outcome Measures

Name	Time	Method
Inertial measurement unit data	1-2 hours	Activity data of the sensors attached to various body parts

Secondary Outcome Measures

Name	Time	Method
surface EMG-data	1-2 hours	rectus femoris/vastus lateralis/gastrocnemius/soleus data

Trial Locations

Locations (1)

Roessingh Research and Development; 🇳🇱 Enschede, Netherlands