Stroke SequelaeSMART-REHABNCT05801874
Gait and Posture Analysis in Hemiparetic Patients Through Optoelectronic Systems, "Smart" Tools and Clinical Evaluation
An observational study of Stroke Sequelae and Hemiparesis, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
The purpose of the study is to validate the use of smart and widespread instruments to detect kinematic, kinetic and spatio-temporal parameters in gait and postural analysis in hemiparetic and healthy individuals. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stroke Sequelae, Hemiparesis, Gait Disorders, Neurologic
- What is being tested?
- Movement analysis
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2021to 1 Sep 2023
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Single laboratory movement analysis with different tools and tecniques
Who may be able to join
- patient with post-stroke chronic hemiparesis (at least 6 month post-acute event)
- ability to stand erect for 30 seconds
- ability to walk with or without aids for 10 meters
Who cannot join
- Moderate/severe cognitive impairment (MMSE < 22)
- Moderate/severe depression (Hamilton Depression Scale > 20)
- Severe spasticity
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto Auxologico Italiano
Milan, 20145
Matteo Bigoni, MD
About this study
The purpose of the study is to validate the use of smart and widespread instruments to detect kinematic, kinetic and spatio-temporal parameters in gait and postural analysis in hemiparetic and healthy individuals. Device as single Microsoft sensor Kinect v2, wearable sensorized clothing and/or smartphone-type devices will be used; it is also planned to analyze and compare such parameters with those obtained through a technique of manual palpatory analysis. Finally the obtained measures will be compared with the corresponding ones obtained with Three-dimensional instrumented gait analysis (3D-GA).
- Conditions
- Stroke Sequelae, Hemiparesis, Gait Disorders, Neurologic
- Being tested
- Movement analysis
- Medical subject headings
- Paresis, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Movement analysisDiagnostic test
Qualitative and quantitative computerized and instrumental assessment of gait and posture.
| Study group | Role | What they receive |
|---|---|---|
| Hemiparetic patients | Hemiparetic patients assessed during gait and stance performance by means of different instrumental tools (smart and portable device vs 3D laboratory gait analysis) in order to evidence gait pattern; kinematics, kinetics and spatio-temporal data. Receives: Diagnostic Test: Movement analysis | |
| Healthy age matched subjects | Healthy age matched subjects assessed during gait and stance performance by means of different instrumental tools (smart and portable device vs 3D laboratory gait analysis) in order to evidence gait pattern; kinematics, kinetics and spatio-temporal data. Receives: Diagnostic Test: Movement analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
GPS (Gait Profile Score index) - differences between techniques
% of agreement between 3D-GA (3 dimensional Gait Analysis - optoelectronic system) and Kinect motion analysis in the detection of kinematic data about gait collected within the GPS (Gait Profile Score Index)
Measured: During movement analysis
Secondary outcomes (1)
Gait cycle values (stance and swing duration) - differences between techniques
% of agreement between 3D-GA (3 dimensional Gait Analysis - optoelectronic system) and Kinect motion analysis in the detection of Gait cycle values (stance and swing duration)
Measured: During movement analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start1 Sep 2021
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke SequelaeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matteo Bigoni, MD, Principal investigator, Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801874
- Sponsor's protocol ID
- 21C130
- Acronym
- SMART-REHAB
- Status last verified
- Mar 2023
- First submitted
- 26 Feb 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait and Posture Analysis in Hemiparetic Patients Through Optoelectronic Systems, "Smart" Tools and Clinical Evaluation
- ClinicalTrials.gov ID
- NCT05801874
- Acronym / sponsor ID
- SMART-REHAB / 21C130
- Conditions
- Stroke Sequelae, Hemiparesis, Gait Disorders, Neurologic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 6 Apr 2023 (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 purpose of the study is to validate the use of smart and widespread instruments to detect kinematic, kinetic and spatio-temporal parameters in gait and postural analysis in hemiparetic and healthy individuals. Device as single Microsoft sensor Kinect v2, wearable sensorized clothing and/or smartphone-type devices will be used; it is also planned to analyze and compare such parameters with those obtained through a technique of manual palpatory analysis. Finally the obtained measures will be compared with the corresponding ones obtained with Three-dimensional instrumented gait analysis (3D-GA).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemiparetic patients | – | Diagnostic Test: Movement analysisHemiparetic patients assessed during gait and stance performance by means of different instrumental tools (smart and portable device vs 3D laboratory gait analysis) in order to evidence gait pattern; kinematics, kinetics and spatio-temporal data. |
| Healthy age matched subjects | – | Diagnostic Test: Movement analysisHealthy age matched subjects assessed during gait and stance performance by means of different instrumental tools (smart and portable device vs 3D laboratory gait analysis) in order to evidence gait pattern; kinematics, kinetics and spatio-temporal data. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Single laboratory movement analysis with different tools and tecniques
Key inclusion criteria (3 listed)
- patient with post-stroke chronic hemiparesis (at least 6 month post-acute event)
- ability to stand erect for 30 seconds
- ability to walk with or without aids for 10 meters
Key exclusion criteria (3 listed)
- Moderate/severe cognitive impairment (MMSE < 22)
- Moderate/severe depression (Hamilton Depression Scale > 20)
- Severe spasticity
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 |
|---|---|---|
| Movement analysisQualitative and quantitative computerized and instrumental assessment of gait and posture. | Diagnostic test | Healthy age matched subjects, Hemiparetic patients |
Primary outcome
GPS (Gait Profile Score index) - differences between techniques
Time frame: During movement analysis
% of agreement between 3D-GA (3 dimensional Gait Analysis - optoelectronic system) and Kinect motion analysis in the detection of kinematic data about gait collected within the GPS (Gait Profile Score Index)
1 secondary outcome
Gait cycle values (stance and swing duration) - differences between techniques
Time frame: During movement analysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
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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.
Matteo Bigoni, MD principal investigator
Istituto Auxologico Italiano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke Sequelae and Hemiparesis, run by Istituto Auxologico Italiano at 1 site in Italy.
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 3 inclusion and 3 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 6 Apr 2023. 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 Italy. 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 Matteo Bigoni, MD (+390323514445, m.bigoni@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GPS (Gait Profile Score index) - differences between techniques (time frame: During movement analysis). 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 6 Apr 2023.