Ischemic StrokeNCT05487287
Computational Assessment of Hand Motor Skills in Stroke Patients
An observational study of Ischemic Stroke, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial summary
This is a two phase prospective observational study that aims to validate the use of a motion capture software (Leap Motion) to measure and quantify functional deficits of the hand in stroke patients using a standard battery of exercises. The objectives of this study are: 1. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Kinematic computational analysis of the hand (Leap Motion device)
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 13 May 2021to 31 Dec 2022
- 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: Cases: 100 subjects with ischemic stroke with functional motor hand deficit Healthy subjects: 100 subjects matched by age with ischemic stroke patients.
Who may be able to join
- Stroke patients: clinically stable, with hand functional deficit at the momment they consent to participate in the study. Signed consent to participate.
- Healthy subjects: similar age to stroke patients, without previous clinical history of stroke or any disease that could affect hand motor skills. Signed consent to participate.
Who cannot join
- Aphasia or cognitive impairment, confusional syndrome or other conditions that could prevent comprehension and acomplishment of the task.
- Plegia or severe paresis of the hand that could prevent adecuate performance of the task.
- Previous stroke.
- Previous dependance.
- Previous diagnosis of any other neurologic disease or condition that could affect hand motricity.
- Life expectancy below three months.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario La Paz
Madrid, 2846
Maria Alonso de Leciñana Cases, 917277444 ext. +34, malecinanacases@salud.madrid.org
Elena de Celis Ruiz, 917277444, elena.decelis.ruiz@idipaz.es
About this study
This is a two phase prospective observational study that aims to validate the use of a motion capture software (Leap Motion) to measure and quantify functional deficits of the hand in stroke patients using a standard battery of exercises. The objectives of this study are:
- To compare the differences between results of hand kinematic computational analysis in patients with ischemic stroke and healthy subjects.
- To analyze the relation between hand kinematic computational analysis and clinical scales usually performed to evalutate neurologic deficits in stroke patients.
- To analyze the relation between hand kinematic computational analysis and stroke lesion on brain MRI.
- To analyze changes between results of hand kinematic computational analysis in the acute phase of stroke and at three months, and its relation with evolution of neurological evaluation clinical scales, functional clinical scales and quality of life.
- Conditions
- Ischemic Stroke
- Being tested
- Kinematic computational analysis of the hand (Leap Motion device)
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinematic computational analysis of the hand (Leap Motion device)Device
Kinematic computational analysis exercises:
- Finger extension
- Wrist extension
- Finger separation
- Finger clamp
| Study group | Role | What they receive |
|---|---|---|
| Ischemic stroke patients with functional deficit of the hand | Not described Receives: Device: Kinematic computational analysis of the hand (Leap Motion device) | |
| Healthy subjects | Not described Receives: Device: Kinematic computational analysis of the hand (Leap Motion device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand kinematic computational analysis
- compare the differences between results of hand kinematic computational analysis in patients with ischemic stroke and healthy subjects.
Measured: First month
Relation between hand kinematic computational analysis and clinical scales
To analyze the relation between hand kinematic computational analysis and clinical scales usually performed to evalutate neurologic deficits in stroke patients.
Measured: First month
Relation between hand kinematic computational analysis and stroke lesion on brain MRI.
To analyze the relation between hand kinematic computational analysis and stroke lesion on brain MRI.
Measured: First month
Results of hand kinematic computational analysis in the acute phase of stroke and at three months, and its relation with evolution of neurological evaluation clinical scales, functional clinical scales and quality of life.
Changes between results of hand kinematic computational analysis in the acute phase of stroke and at three months, and its relation with evolution of neurological evaluation clinical scales, functional clinical scales and quality of life.
Measured: 1 month and three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start13 May 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario La Paz, Universidad Politecnica de Madrid
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487287
- Sponsor's protocol ID
- PI-4776
- Status last verified
- May 2022
- First submitted
- 10 Jun 2022
- Last updated
- 4 Aug 2022
- 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 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computational Assessment of Hand Motor Skills in Stroke Patients
- ClinicalTrials.gov ID
- NCT05487287
- Acronym / sponsor ID
- PI-4776
- Conditions
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- Hospital Universitario La Paz, Universidad Politecnica de Madrid
- Study start
- 13 May 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 4 Aug 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.
This is a two phase prospective observational study that aims to validate the use of a motion capture software (Leap Motion) to measure and quantify functional deficits of the hand in stroke patients using a standard battery of exercises. The objectives of this study are:
- To compare the differences between results of hand kinematic computational analysis in patients with ischemic stroke and healthy subjects.
- To analyze the relation between hand kinematic computational analysis and clinical scales usually performed to evalutate neurologic deficits in stroke patients.
- To analyze the relation between hand kinematic computational analysis and stroke lesion on brain MRI.
- To analyze changes between results of hand kinematic computational analysis in the acute phase of stroke and at three months, and its relation with evolution of neurological evaluation clinical scales, functional clinical scales and quality of life.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ischemic stroke patients with functional deficit of the hand | – | Device: Kinematic computational analysis of the hand (Leap Motion device) |
| Healthy subjects | – | Device: Kinematic computational analysis of the hand (Leap Motion device) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cases: 100 subjects with ischemic stroke with functional motor hand deficit Healthy subjects: 100 subjects matched by age with ischemic stroke patients.
Key inclusion criteria (2 listed)
- Stroke patients: clinically stable, with hand functional deficit at the momment they consent to participate in the study. Signed consent to participate.
- Healthy subjects: similar age to stroke patients, without previous clinical history of stroke or any disease that could affect hand motor skills. Signed consent to participate.
Key exclusion criteria (6 listed)
- Aphasia or cognitive impairment, confusional syndrome or other conditions that could prevent comprehension and acomplishment of the task.
- Plegia or severe paresis of the hand that could prevent adecuate performance of the task.
- Previous stroke.
- Previous dependance.
- Previous diagnosis of any other neurologic disease or condition that could affect hand motricity.
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 |
|---|---|---|
| Kinematic computational analysis of the hand (Leap Motion device)Kinematic computational analysis exercises: 1. Finger extension 2. Wrist extension 3. Finger separation 4. Finger clamp | Device | Healthy subjects, Ischemic stroke patients with functional deficit of the hand |
Primary outcome
Hand kinematic computational analysis
Time frame: First month
o compare the differences between results of hand kinematic computational analysis in patients with ischemic stroke and healthy subjects.
Relation between hand kinematic computational analysis and clinical scales
Time frame: First month
To analyze the relation between hand kinematic computational analysis and clinical scales usually performed to evalutate neurologic deficits in stroke patients.
Relation between hand kinematic computational analysis and stroke lesion on brain MRI.
Time frame: First month
To analyze the relation between hand kinematic computational analysis and stroke lesion on brain MRI.
Results of hand kinematic computational analysis in the acute phase of stroke and at three months, and its relation with evolution of neurological evaluation clinical scales, functional clinical scales and quality of life.
Time frame: 1 month and three months
Changes between results of hand kinematic computational analysis in the acute phase of stroke and at three months, and its relation with evolution of neurological evaluation clinical scales, functional clinical scales and quality of life.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 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.
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 Ischemic Stroke, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
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 2 inclusion and 6 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 4 Aug 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 Spain. 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 María Alonso de Leciñana Cases (917277444 ext. +34, malecinanacases@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand kinematic computational analysis (time frame: First month). The study lists 4 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 4 Aug 2022.