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Status unknownNCT05487287Updated Aug 4, 2022

Computational Assessment of Hand Motor Skills in Stroke Patients

An observational study in Ischemic Stroke, sponsored by Instituto de Investigación Hospital Universitario La Paz. Status unknown at 1 site in Spain. Per ClinicalTrials.gov, last updated 2022-08-04.

Sponsored by Instituto de Investigación Hospital Universitario La Paz · Observational

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
200
Sex
All
01

Study 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.
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Conditions studied

  • Ischemic Stroke

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03

In context

Ischemic Stroke

2,653 studies on the registry are indexed under Ischemic Stroke; 936 are open to participants now.

This study's planned enrollment of 200 is below the median of 300 across 787 observational studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz is the lead sponsor of 104 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Cases: 100 subjects with ischemic stroke with functional motor hand deficit Healthy subjects: 100 subjects matched by age with ischemic stroke patients.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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)

Interventions

  • DeviceKinematic computational analysis of the hand (Leap Motion device)

    Kinematic computational analysis exercises: 1. Finger extension 2. Wrist extension 3. Finger separation 4. Finger clamp

06

What researchers measure

Primary outcomes

  1. Hand kinematic computational analysis

    o compare the differences between results of hand kinematic computational analysis in patients with ischemic stroke and healthy subjects.

    Time frame: First month

  2. 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.

    Time frame: First month

  3. 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.

    Time frame: First month

  4. 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.

    Time frame: 1 month and three months

07

Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05487287
Collaborators
Hospital Universitario La Paz, Universidad Politecnica de Madrid
Responsible party
Sponsor
First posted
Aug 4, 2022
Start date
May 13, 2021
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Aug 4, 2022

Study contacts

María Alonso de Leciñana Cases
Contact
malecinanacases@salud.madrid.org
917277444 ext. +34
Elena de Celis Ruiz
Contact
elena.decelis.ruiz@idipaz.es
917277444 ext. +34

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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