NCT05205824

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

December 22, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 25, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2022

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

5 months

First QC Date

December 21, 2021

Last Update Submit

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

OTHER

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

Other: algorithm validation

Interventions

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

Algorithm validation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • C Nikamp, PhD

    Roessingh Research and Development

    PRINCIPAL INVESTIGATOR

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

Locations