Validation IMU and EMG Algorithms in Stroke Patients

Stroke Clinical Trial

Official title:

Validation IMU and EMG Algorithms in Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05205824
• Other study ID #: 2021-8218
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Stroke

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