Clinical trial NCT04464863: Kinematic Analysis in Stroke Patients Using Microsoft Kinect and Akira Software: Kinect-Akira Movement Study
Official title: Kinematic Analysis in Stroke Patients Using Microsoft Kinect and Akira Software: Kinect-Akira Movement Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute stroke patients and healthy controls, matched by age and sex. The inclusion and exclusion criteria are defined below

Brief summary: In this prospective, unicentric, case-control study, the main aim is to analyze joint movement and walking patterns in patients with acute stroke with a marker-free motion capture system. Case group: Stroke patients who fulfill the inclusion criteria are invited to participate in the study during admission. The evaluation consists of a workout designed by expert rehabilitation physicians and neurologists that is performed by the patient in front of the Microsoft Kinect camera. The custom-built software Akira record the joint angles of body trunk and upper limbs during the workout. The kinematic data will be analyzed with a machine learning algorithm that classifies the participant according to the kinematic data in normal movement or impaired movement (with the degree of impairment) by age decade. Control group: healthy participants (without neurological or osteomuscular diseases) matched by age and sex with cases 1:1. The correlation between kinematic and clinical scales (NIHSS) and functional scales (modified Rankin Scale) will be analyzed. A secondary objective will be to analyze the predictive value of the kinematic measurements with the functional outcome at three months


Eligibility criteria: Inclusion Criteria:

* Acute Stroke patients (within the first week of index stroke)
* Neurological deficit present at the moment of the evaluation.
* Informed consent signed.

Exclusion Criteria:

* Clinical instability
* Aphasia or cognitive decline that prevents the understanding of the workout.
* Refuse to participate
* Previous neurological or osteomuscular conditions.
* Previous conditions with less than 3 months of expectancy of life.

Primary outcomes:
measure: Kinematic metrics: join angles
timeFrame: The change between the first week of index stroke (acute phase) and at 3 months after index stroke
measure: Kinematic metrics: movement acceleration
timeFrame: The change between the first week of index stroke (acute phase) and at 3 months after index stroke
measure: Kinematic metrics: movement pattern
timeFrame: The change between the first week of index stroke (acute phase) and at 3 months after index stroke
Secondary outcomes:
measure: Relationship of kinematic measures with the degree of disability after stroke.
timeFrame: At 3 months after the index stroke
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: La Paz University Hospital, IdiPAZ
Study officials:
affiliation: Hospital Universitario La Paz, IdiPAZ
name: María Alonso de Leciñana, MD PhD
role: STUDY_DIRECTOR
References: