Clinical trial NCT05487287: Computational Assessment of Hand Motor Skills in Stroke Patients
Official title: Computational Assessment of Hand Motor Skills in Stroke Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Stroke
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
Collaborators: name: Hospital Universitario La Paz
name: Universidad Politecnica de Madrid
First posted: 2022-08-04
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Hand kinematic computational analysis
timeFrame: First month
measure: Relation between hand kinematic computational analysis and clinical scales
timeFrame: First month
measure: Relation between hand kinematic computational analysis and stroke lesion on brain MRI.
timeFrame: First month
measure: 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.
timeFrame: 1 month and three months
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
References: