StrokeNCT05205824
Validation IMU and EMG Algorithms in Stroke Patients
A study testing algorithm validation in people with Stroke, run by Roessingh Research and Development at 1 site in Netherlands.
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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- algorithm validation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Dec 2021to 25 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- subjects with neurological or motor disorders that could interfere with the measurements (other than stroke) or severe deficits in communication, memory and understanding.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- algorithm validation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
algorithm validationOther
stroke subjects are measured to validate algorithms previously developed after including healthy subjects
| Study group | Role | What they receive |
|---|---|---|
| Algorithm validation | Other | all subjects will be measured with inertial measurement units while performing tasks like walking, standing and sitting. Receives: Other: algorithm validation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inertial measurement unit data
Activity data of the sensors attached to various body parts
Measured: 1-2 hours
Secondary outcomes (1)
surface EMG-data
rectus femoris/vastus lateralis/gastrocnemius/soleus data
Measured: 1-2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start22 Dec 2021
- Primary completion25 May 2022
- Study completion25 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roessingh Research and Development
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- C Nikamp, PhD, Principal investigator, Roessingh Research and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205824
- Sponsor's protocol ID
- 2021-8218
- Status last verified
- Jul 2022
- First submitted
- 21 Dec 2021
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: not decided within the consortium yet
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation IMU and EMG Algorithms in Stroke Patients
- ClinicalTrials.gov ID
- NCT05205824
- Acronym / sponsor ID
- 2021-8218
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Roessingh Research and DevelopmentUniversity, hospital or other
- Study start
- 22 Dec 2021 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Algorithm validation | Other | Other: algorithm validationall subjects will be measured with inertial measurement units while performing tasks like walking, standing and sitting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- subjects with neurological or motor disorders that could interfere with the measurements (other than stroke) or severe deficits in communication, memory and understanding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| algorithm validationstroke subjects are measured to validate algorithms previously developed after including healthy subjects | Other | Algorithm validation |
Primary outcome
Inertial measurement unit data
Time frame: 1-2 hours
Activity data of the sensors attached to various body parts
1 secondary outcome
surface EMG-data
Time frame: 1-2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Individual participant dataSharing planned: Undecided. not decided within the consortium yet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
C Nikamp, PhD principal investigator
Roessingh Research and Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing algorithm validation in people with Stroke, run by Roessingh Research and Development at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inertial measurement unit data (time frame: 1-2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.