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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05487287
Other study ID # PI-4776
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 13, 2021
Est. completion date December 31, 2022

Study information

Verified date May 2022
Source Instituto de Investigación Hospital Universitario La Paz
Contact María Alonso de Leciñana Cases
Phone 917277444
Email malecinanacases@salud.madrid.org
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Kinematic computational analysis of the hand (Leap Motion device)
Kinematic computational analysis exercises: Finger extension Wrist extension Finger separation Finger clamp

Locations

Country Name City State
Spain Hospital Universitario La Paz Madrid

Sponsors (3)

Lead Sponsor Collaborator
Instituto de Investigación Hospital Universitario La Paz Hospital Universitario La Paz, Universidad Politecnica de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hand kinematic computational analysis o compare the differences between results of hand kinematic computational analysis in patients with ischemic stroke and healthy subjects. First month
Primary 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. First month
Primary 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. First month
Primary 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. 1 month and three months
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