NCT05487287

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 13, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 4, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

August 4, 2022

Status Verified

May 1, 2022

Enrollment Period

1.6 years

First QC Date

June 10, 2022

Last Update Submit

August 2, 2022

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

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

Kinematic computational analysis of the hand (Leap Motion device)DEVICE

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

Healthy subjectsIschemic stroke patients with functional deficit of the hand

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario La Paz

Madrid, 2846, Spain

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

María Alonso de Leciñana Cases

CONTACT

917277444malecinanacases@salud.madrid.org

Elena de Celis Ruiz

CONTACT

917277444elena.decelis.ruiz@idipaz.es

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2022

First Posted

August 4, 2022

Study Start

May 13, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

August 4, 2022

Record last verified: 2022-05

Locations

ES(1)