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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05205824
Other study ID # 2021-8218
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 22, 2021
Est. completion date May 25, 2022

Study information

Verified date July 2022
Source Roessingh Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date May 25, 2022
Est. primary completion date May 25, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
algorithm validation
stroke subjects are measured to validate algorithms previously developed after including healthy subjects

Locations

Country Name City State
Netherlands Roessingh Research and Development Enschede

Sponsors (1)

Lead Sponsor Collaborator
Roessingh Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Other anonymized video data Video data of the measurements performed 1-2 hours
Other Age Age (in years) at inclusion
Other Height Height (in cm) at inclusion
Other Leg length Leg length (in cm) at inclusion
Other Time since stroke time since stroke (in years) at inclusion
Other Type of stroke type of stroke (ischemic or hemorrhagic) at inclusion
Other Body side Affected and dominant body side (left or right) at inclusion
Other FAC-score Functional Ambulation Categories score (0-5 points) to assess independence of walking at inclusion
Other Motricity Index Motricity index lower limb (0-33 points) at inclusion
Primary Inertial measurement unit data Activity data of the sensors attached to various body parts 1-2 hours
Secondary surface EMG-data rectus femoris/vastus lateralis/gastrocnemius/soleus data 1-2 hours
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