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Validation IMU and EMG Algorithms in Stroke Patients

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
algorithm validation
Sponsored by
Roessingh Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Roessingh Research and Development

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Algorithm validation

Arm Description

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

Outcomes

Primary Outcome Measures

Inertial measurement unit data
Activity data of the sensors attached to various body parts

Secondary Outcome Measures

surface EMG-data
rectus femoris/vastus lateralis/gastrocnemius/soleus data

Full Information

First Posted
December 21, 2021
Last Updated
July 15, 2022
Sponsor
Roessingh Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05205824
Brief Title
Validation IMU and EMG Algorithms in Stroke Patients
Official Title
Validation IMU and EMG Algorithms in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
December 22, 2021 (Actual)
Primary Completion Date
May 25, 2022 (Actual)
Study Completion Date
May 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roessingh Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Algorithm validation
Arm Type
Other
Arm Description
all subjects will be measured with inertial measurement units while performing tasks like walking, standing and sitting.
Intervention Type
Other
Intervention Name(s)
algorithm validation
Intervention Description
stroke subjects are measured to validate algorithms previously developed after including healthy subjects
Primary Outcome Measure Information:
Title
Inertial measurement unit data
Description
Activity data of the sensors attached to various body parts
Time Frame
1-2 hours
Secondary Outcome Measure Information:
Title
surface EMG-data
Description
rectus femoris/vastus lateralis/gastrocnemius/soleus data
Time Frame
1-2 hours
Other Pre-specified Outcome Measures:
Title
anonymized video data
Description
Video data of the measurements performed
Time Frame
1-2 hours
Title
Age
Description
Age (in years)
Time Frame
at inclusion
Title
Height
Description
Height (in cm)
Time Frame
at inclusion
Title
Leg length
Description
Leg length (in cm)
Time Frame
at inclusion
Title
Time since stroke
Description
time since stroke (in years)
Time Frame
at inclusion
Title
Type of stroke
Description
type of stroke (ischemic or hemorrhagic)
Time Frame
at inclusion
Title
Body side
Description
Affected and dominant body side (left or right)
Time Frame
at inclusion
Title
FAC-score
Description
Functional Ambulation Categories score (0-5 points) to assess independence of walking
Time Frame
at inclusion
Title
Motricity Index
Description
Motricity index lower limb (0-33 points)
Time Frame
at inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C Nikamp, PhD
Organizational Affiliation
Roessingh Research and Development
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roessingh Research and Development
City
Enschede
ZIP/Postal Code
7522AH
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
not decided within the consortium yet

Learn more about this trial

Validation IMU and EMG Algorithms in Stroke Patients

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