Computational Assessment of Hand Motor Skills in Stroke Patients

• Conditions: Ischemic Stroke
• Interventions: Device: Kinematic computational analysis of the hand (Leap Motion device)

• Registration Number: NCT05487287
• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-13
• Status Verified: 2022-05
• Study First Submitted: 2022-06-10
• Study First Submitted QC: 2022-08-02
• Last Update Submitted: 2022-08-02
• Study First Posted: 2022-08-04
• Last Update Posted: 2022-08-04
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ischemic stroke patients with functional deficit of the hand	Kinematic computational analysis of the hand (Leap Motion device)	-
Healthy subjects	Kinematic computational analysis of the hand (Leap Motion device)	-

Primary Outcome Measures

Name	Time	Method
Relation between hand kinematic computational analysis and stroke lesion on brain MRI.	First month	To analyze the relation between hand kinematic computational analysis and stroke lesion on brain MRI.
Relation between hand kinematic computational analysis and clinical scales	First month	To analyze the relation between hand kinematic computational analysis and clinical scales usually performed to evalutate neurologic deficits in stroke patients.
Hand kinematic computational analysis	First month	o compare the differences between results of hand kinematic computational analysis in patients with ischemic stroke and healthy subjects.
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	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.

Trial Locations

Locations (1)

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain