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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: algorithm validation

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Enschede, Netherlands, 7522AH
    • Roessingh Research and Development

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Algorithm validation; all subjects will be measured with inertial measurement units while performing tasks like walking, standing and sitting.	Other: algorithm validation; stroke subjects are measured to validate algorithms previously developed after including healthy subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inertial measurement unit data	Activity data of the sensors attached to various body parts	1-2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
surface EMG-data	rectus femoris/vastus lateralis/gastrocnemius/soleus data	1-2 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
anonymized video data	Video data of the measurements performed	1-2 hours
Age	Age (in years)	at inclusion
Height	Height (in cm)	at inclusion
Leg length	Leg length (in cm)	at inclusion
Time since stroke	time since stroke (in years)	at inclusion
Type of stroke	type of stroke (ischemic or hemorrhagic)	at inclusion
Body side	Affected and dominant body side (left or right)	at inclusion
FAC-score	Functional Ambulation Categories score (0-5 points) to assess independence of walking	at inclusion
Motricity Index	Motricity index lower limb (0-33 points)	at inclusion

Collaborators and Investigators

• Sponsor: Roessingh Research and Development
• Investigators: Principal Investigator: C Nikamp, PhD, Roessingh Research and Development

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2021
• Primary Completion (Actual): May 25, 2022
• Study Completion (Actual): May 25, 2022

Study Registration Dates

• First Submitted: December 21, 2021
• First Submitted That Met QC Criteria: January 12, 2022
• First Posted (Actual): January 25, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 15, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2021-8218

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: not decided within the consortium yet

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No