StrokeNCT05295654
Validity of the Kinect™ Sensor for Measuring Range of Motion in Patients Post-stroke and Healthy Test Subject
A study testing Kinect validation in people with Stroke and Healthy, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial summary
The aim of this research is to investigate the validity of the Kinect™ sensor in post-stroke patients and in healthy test subjects during analytic and functional movements. Measurements will be compared with the Vicon-camera system (currently seen as the golden standard). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Kinect validation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Apr 2022to 31 Dec 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- People post-stroke or healthy test subjects
- Language: Dutch, English or French
- Age ≥ 18
- Able to sit and stand unsupported for 30 s or more
- Able to stand up from a chair without aid of another person
- Able to signal pain, fear of discomfort
- Able to give informed consent (based on the advice of a medical doctor)
- Able to understand and perform the instructions and to answer questions
Who cannot join
- Concurrent orthopedic and/or musculoskeletal pathologies or disorders that may limit the range of motion (including limb amputations)
- Concurrent neurological disorders (e.g. Parkinson's Disease, Multiple Sclerosis or Amyotrophic Lateral Sclerosis)
- Persons with comorbidity that could hinder the study (e.g. unstable cardiovascular system disorders, lung disorders, severe osteoporosis)
- People with difficulties of speech and/or memory providing that instruction cannot be followed or understood adequate
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Brubotics Rehabilitation Research Center
Brussels, 1090
Eva Swinnen
About this study
The aim of this research is to investigate the validity of the Kinect™ sensor in post-stroke patients and in healthy test subjects during analytic and functional movements. Measurements will be compared with the Vicon-camera system (currently seen as the golden standard).
Read the detailed description
STUDY DESIGN
This study is a cross-sectional study in which healthy people and people post stroke will perform 1 session where we will investigate the validity of the Kinect sensor.
MATERIALS
- The VICON system The Vicon Camera system is a marker-based system (MBS) to evaluate and analyse movements. Markers are placed on predetermined locations on the skin of the patient according to the Plug in Gait (PIG) full body model. Examination will take place in underwear. A 14-camera infrared opto-electronic video-based motion analysis system with a sample rate of 100 Hz (Vicon MX T40-S, Vicon Motion Systems, Oxford, UK) is used as golden standard. Two synchronized video cameras (Bonita 720C, Vicon, UK) will film the front and side of the participants at a sample rate of 100 Hz.
- The Kinect system
The Kinect™ system is a markerless-system. It uses a skeleton model to estimate the joint and relative segment orientations. The Kinect-camera will be placed on a tripod at 1,5m height and patients will stand 2m from the camera as recommended by the manufacturer The Kinect™ Azure is the newest version of this system and will be used in this study.
PROCEDURE
All participants will be informed about the study (information document) and a confirmed written informed consent will be obtained by each participant. Baseline demographic and/or clinical characteristics from participants will be obtained by questioning and by searching medical files.
The participant will perform following analytical movements bilateral, both in sitting and standing position:
Hip:
- Hip flexion (standing position): participant lifts one leg in standing position.
- Hip flexion (sitting position): participant lifts one knee as high as possible while seated. The leg can be bend.
- Hip abduction (standing position): participant lifts one leg sidewards as high as possible.
- Hip abduction (sitting position): participant starts with two knees together and then moves one knee outwards as far as possible.
- Hip adduction: patient moves one leg to the other side (in front of the standing leg)
Knee:
- Knee flexion (standing position): participant bends through his/her knees as deep as possible
- Knee flexion (standing position): participant brings one foot towards the butt while maintaining the thigh in the same position
- Knee flexion (sitting position): participant sits on a chair and moves one foot backward (under the chair).
- Knee extension (sitting position): participant sits on a chair and extend his/her knee.
Shoulder:
- Shoulder anteflexion: participant moves the arm upward in front of him/her as high as possible.
- Shoulder abduction (standing position): participant moves the arm upward next to his/her body as high as possible.
- Shoulder adduction: participant moves his/her arm in front of the body to the other side
- Shoulder horizontal adduction: participant lifts his/her arm to an angle of 90° and then moves the arm to the other shoulder (like going to touch the other shoulder with the hand that moves), but the elbow stays extended.
Elbow:
- Elbow flexion in 90° abduction in frontal plane: participant holds the arm in an angle of 90° next to his/her body and moves the hand towards the shoulder while keeping the upper arm in the same position.
- Elbow flexion in 90° anteflexion in sagittal plane: participant holds the arm in an angle of 90° in front of his/her body and moves the hand towards the shoulder while keeping the upper arm in the same position.
- Elbow flexion in 0° abduction: participant needs to bring the hand towards the shoulder in the front of his/her body while keeping the upper arm against the trunk
The following functional movements will be performed:
- Grasping + hand-to-mouth movement: The participant starts with hands next to his/her body. The participant will have to grasp something and bring it to his/her mouth.
- Sit-to-stand: The participant is seated and will have to stand up straight. Afterwards, the participant has to sit down again.
- Touching shoulder with heterolateral hand: The arm of the participant will hang next to his/her body. The participant has to touch the heterolateral shoulder. This will be performed with both sides.
Participants will perform 5 repetitions per movement, with 2 seconds between every repetition. Each side is moved separately.
If necessary, for safety reasons, the participant can use a walking aid to maintain the balance (e.g. rollator, crutch, …).
STATISTICAL ANALYSIS
Statistical analysis will be performed using SPSS version 23 (IBM, Chicago, IL). Significance will be set at 5%. The statistical analysis will be performed by the investigators.
To determine the validity, intraclass correlation coefficients will be calculated. Based on the 95% confidence intervals of the ICC estimates, agreement will be rated poor (less than 0.50), moderate (between 0.50 and 0.75), good (between 0.75 and 0.90) or excellent (greater than 0.90). Mean differences and standard deviations will also be calculated and interpreted.
- Being tested
- Kinect validation
- Keywords
- Kinect, Validity, Vicon
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinect validationOther
Participants will perform several movements while both the vicon and kinect are measuring.
| Study group | Role | What they receive |
|---|---|---|
| Kinect validation | Experimental | Kinect measurements will be compared with the vicon measurements to validate the kinect system. Receives: Other: Kinect validation |
What is being measured
The primary outcome is the main question the study is designed to answer.
3D kinematic measurements lower limb
Kinematic data (i.e. movement amplitudes of the bilateral hip, knee and ankle joint in degrees) of the lower limbs during the movements will be recorded continuously with the use of the VICON Vero 1.3 system at 100 Hz.
Measured: through study completion, an average of 1 year
3D kinematic measurements upper limb
Kinematic data (i.e. movement amplitudes of the head, neck, spine, thorax and bilateral shoulder, elbow and wrist joint in degrees) of the lower limbs during the movements will be recorded continuously with the use of the VICON Vero 1.3 system at 100 Hz.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start14 Apr 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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.
- More trials run by Vrije Universiteit BrusselThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emma De Keersmaecker, Vrije Universiteit Brussel
- Investigators
- Eva Swinnen, Prof. Ph.D, Principal investigator, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295654
- Sponsor's protocol ID
- Kinect validity study
- Status last verified
- Oct 2022
- First submitted
- 15 Mar 2022
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of the Kinect™ Sensor for Measuring Range of Motion in Patients Post-stroke and Healthy Test Subject
- ClinicalTrials.gov ID
- NCT05295654
- Acronym / sponsor ID
- Kinect validity study
- Keywords
- Kinect, Validity, Vicon
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 25 Mar 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 aim of this research is to investigate the validity of the Kinect™ sensor in post-stroke patients and in healthy test subjects during analytic and functional movements. Measurements will be compared with the Vicon-camera system (currently seen as the golden standard).
Detailed description
STUDY DESIGN
This study is a cross-sectional study in which healthy people and people post stroke will perform 1 session where we will investigate the validity of the Kinect sensor.
MATERIALS
- The VICON system The Vicon Camera system is a marker-based system (MBS) to evaluate and analyse movements. Markers are placed on predetermined locations on the skin of the patient according to the Plug in Gait (PIG) full body model. Examination will take place in underwear. A 14-camera infrared opto-electronic video-based motion analysis system with a sample rate of 100 Hz (Vicon MX T40-S, Vicon Motion Systems, Oxford, UK) is used as golden standard. Two synchronized video cameras (Bonita 720C, Vicon, UK) will film the front and side of the participants at a sample rate of 100 Hz.
- The Kinect system
The Kinect™ system is a markerless-system. It uses a skeleton model to estimate the joint and relative segment orientations. The Kinect-camera will be placed on a tripod at 1,5m height and patients will stand 2m from the camera as recommended by the manufacturer The Kinect™ Azure is the newest version of this system and will be used in this study.
PROCEDURE
All participants will be informed about the study (information document) and a confirmed written informed consent will be obtained by each participant. Baseline demographic and/or clinical characteristics from participants will be obtained by questioning and by searching medical files.
The participant will perform following analytical movements bilateral, both in sitting and standing position:
Hip:
- Hip flexion (standing position): participant lifts one leg in standing position.
- Hip flexion (sitting position): participant lifts one knee as high as possible while seated. The leg can be bend.
- Hip abduction (standing position): participant lifts one leg sidewards as high as possible.
- Hip abduction (sitting position): participant starts with two knees together and then moves one knee outwards as far as possible.
- Hip adduction: patient moves one leg to the other side (in front of the standing leg)
Knee:
- Knee flexion (standing position): participant bends through his/her knees as deep as possible
- Knee flexion (standing position): participant brings one foot towards the butt while maintaining the thigh in the same position
- Knee flexion (sitting position): participant sits on a chair and moves one foot backward (under the chair).
- Knee extension (sitting position): participant sits on a chair and extend his/her knee.
Shoulder:
- Shoulder anteflexion: participant moves the arm upward in front of him/her as high as possible.
- Shoulder abduction (standing position): participant moves the arm upward next to his/her body as high as possible.
- Shoulder adduction: participant moves his/her arm in front of the body to the other side
- Shoulder horizontal adduction: participant lifts his/her arm to an angle of 90° and then moves the arm to the other shoulder (like going to touch the other shoulder with the hand that moves), but the elbow stays extended.
Elbow:
- Elbow flexion in 90° abduction in frontal plane: participant holds the arm in an angle of 90° next to his/her body and moves the hand towards the shoulder while keeping the upper arm in the same position.
- Elbow flexion in 90° anteflexion in sagittal plane: participant holds the arm in an angle of 90° in front of his/her body and moves the hand towards the shoulder while keeping the upper arm in the same position.
- Elbow flexion in 0° abduction: participant needs to bring the hand towards the shoulder in the front of his/her body while keeping the upper arm against the trunk
The following functional movements will be performed:
- Grasping + hand-to-mouth movement: The participant starts with hands next to his/her body. The participant will have to grasp something and bring it to his/her mouth.
- Sit-to-stand: The participant is seated and will have to stand up straight. Afterwards, the participant has to sit down again.
- Touching shoulder with heterolateral hand: The arm of the participant will hang next to his/her body. The participant has to touch the heterolateral shoulder. This will be performed with both sides.
Participants will perform 5 repetitions per movement, with 2 seconds between every repetition. Each side is moved separately.
If necessary, for safety reasons, the participant can use a walking aid to maintain the balance (e.g. rollator, crutch, …).
STATISTICAL ANALYSIS
Statistical analysis will be performed using SPSS version 23 (IBM, Chicago, IL). Significance will be set at 5%. The statistical analysis will be performed by the investigators.
To determine the validity, intraclass correlation coefficients will be calculated. Based on the 95% confidence intervals of the ICC estimates, agreement will be rated poor (less than 0.50), moderate (between 0.50 and 0.75), good (between 0.75 and 0.90) or excellent (greater than 0.90). Mean differences and standard deviations will also be calculated and interpreted.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kinect validation | Experimental | Other: Kinect validationKinect measurements will be compared with the vicon measurements to validate the kinect system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- People post-stroke or healthy test subjects
- Language: Dutch, English or French
- Age ≥ 18
- Able to sit and stand unsupported for 30 s or more
- Able to stand up from a chair without aid of another person
Key exclusion criteria (4 listed)
- Concurrent orthopedic and/or musculoskeletal pathologies or disorders that may limit the range of motion (including limb amputations)
- Concurrent neurological disorders (e.g. Parkinson's Disease, Multiple Sclerosis or Amyotrophic Lateral Sclerosis)
- Persons with comorbidity that could hinder the study (e.g. unstable cardiovascular system disorders, lung disorders, severe osteoporosis)
- People with difficulties of speech and/or memory providing that instruction cannot be followed or understood adequate
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 |
|---|---|---|
| Kinect validationParticipants will perform several movements while both the vicon and kinect are measuring. | Other | Kinect validation |
Primary outcome
3D kinematic measurements lower limb
Time frame: through study completion, an average of 1 year
Kinematic data (i.e. movement amplitudes of the bilateral hip, knee and ankle joint in degrees) of the lower limbs during the movements will be recorded continuously with the use of the VICON Vero 1.3 system at 100 Hz.
3D kinematic measurements upper limb
Time frame: through study completion, an average of 1 year
Kinematic data (i.e. movement amplitudes of the head, neck, spine, thorax and bilateral shoulder, elbow and wrist joint in degrees) of the lower limbs during the movements will be recorded continuously with the use of the VICON Vero 1.3 system at 100 Hz.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
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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.
Eva Swinnen, Prof. Ph.D principal investigator
Vrije Universiteit Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinect validation in people with Stroke and Healthy, run by Vrije Universiteit Brussel at 1 site in Belgium.
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 8 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 19 Oct 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eva Swinnen, Prof. Ph.D (003224774527, eva.swinnen@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3D kinematic measurements lower limb (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 Oct 2022.