Computational Assessment of Hand Motor Skills in Stroke Patients

NCT ID: NCT05487287

Last Updated: 2022-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-13

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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. To compare the differences between results of hand kinematic computational analysis in patients with ischemic stroke and healthy subjects.
2. To analyze the relation between hand kinematic computational analysis and clinical scales usually performed to evalutate neurologic deficits in stroke patients.
3. To analyze the relation between hand kinematic computational analysis and stroke lesion on brain MRI.
4. 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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ischemic Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ischemic stroke patients with functional deficit of the hand

Kinematic computational analysis of the hand (Leap Motion device)

Intervention Type DEVICE

Kinematic computational analysis exercises:

1. Finger extension
2. Wrist extension
3. Finger separation
4. Finger clamp

Healthy subjects

Kinematic computational analysis of the hand (Leap Motion device)

Intervention Type DEVICE

Kinematic computational analysis exercises:

1. Finger extension
2. Wrist extension
3. Finger separation
4. Finger clamp

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital Universitario La Paz

OTHER

Sponsor Role collaborator

Universidad Politecnica de Madrid

OTHER

Sponsor Role collaborator

Instituto de Investigación Hospital Universitario La Paz

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Universitario La Paz

Madrid, , Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

María Alonso de Leciñana Cases

Role: CONTACT

917277444 ext. +34

Elena de Celis Ruiz

Role: CONTACT

917277444 ext. +34

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Maria Alonso de Leciñana Cases

Role: primary

917277444 ext. +34

Elena de Celis Ruiz

Role: backup

917277444

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PI-4776

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.