Validation IMU and EMG Algorithms in Stroke Patients
1 other identifier
interventional
7
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Dec 2021
Shorter than P25 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2021
CompletedStudy Start
First participant enrolled
December 22, 2021
CompletedFirst Posted
Study publicly available on registry
January 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2022
CompletedJuly 19, 2022
July 1, 2022
5 months
December 21, 2021
July 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Inertial measurement unit data
Activity data of the sensors attached to various body parts
1-2 hours
Secondary Outcomes (1)
surface EMG-data
1-2 hours
Other Outcomes (9)
anonymized video data
1-2 hours
Age
at inclusion
Height
at inclusion
- +6 more other outcomes
Study Arms (1)
Algorithm validation
OTHERall subjects will be measured with inertial measurement units while performing tasks like walking, standing and sitting.
Interventions
stroke subjects are measured to validate algorithms previously developed after including healthy subjects
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- subjects with neurological or motor disorders that could interfere with the measurements (other than stroke) or severe deficits in communication, memory and understanding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Roessingh Research and Development
Enschede, 7522AH, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
C Nikamp, PhD
Roessingh Research and Development
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2021
First Posted
January 25, 2022
Study Start
December 22, 2021
Primary Completion
May 25, 2022
Study Completion
May 25, 2022
Last Updated
July 19, 2022
Record last verified: 2022-07