Kinematic Analysis in Stroke Patients Using Microsoft Kinect and Akira Software: Kinect-Akira Movement Study (KAM)

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

Study Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: Other: Kinematic metrics

• Study Type: Observational
• Enrollment (Anticipated): 140

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28046
    • Recruiting
    • La Paz University Hospital, IdiPAZ
    • Sub-Investigator: Silvia Pastor Yvorra
    • Contact: Exuperio Díez Tejedor, MD, PhD, Prof.; Phone Number: +34 917277444; Email: exuperio-diez@salud.madrid.org
    • Contact: Raquel Gutiérrez Zúñiga, MD; Phone Number: +34 917277444; Email: rgutierrezz@salud.madrid.org
    • Sub-Investigator: Blanca Fuentes Gimeno
    • Sub-Investigator: María Alonso de Leciñana
    • Sub-Investigator: Elena de Celis Ruiz
    • Sub-Investigator: Raquel Gutiérrez Zúñiga
    • Sub-Investigator: Ricardo Riguel Bobillo
    • Sub-Investigator: Gerardo Ruiz Ares
    • Sub-Investigator: Jorge Rodríguez Pardo
    • Sub-Investigator: Begoña Marín
    • Sub-Investigator: Lucía Millet
    • Principal Investigator: Exuperio Díez Tejedor
    • Sub-Investigator: David Hernández

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases; Acute stroke patients during the first week of evolution	Other: Kinematic metrics; kinematic metrics recorded with Kinect (register brand) and extracted with Akira (register brand)
Control; Age and sex 1:1 healthy participants	Other: Kinematic metrics; kinematic metrics recorded with Kinect (register brand) and extracted with Akira (register brand)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kinematic metrics: join angles	The kinect camera together with the software Akira will be used to automatically measure the degree angle of the following body joints: shoulder in abduction, shoulder inflexion, elbow in extension and in flexion and the angle formed by the forearm and the trunk with the shoulder in abduction.	The change between the first week of index stroke (acute phase) and at 3 months after index stroke
Kinematic metrics: movement acceleration	The kinect camera together with the software Akira will be used to automatically measure the acceleration of the following movements: shoulder abduction and shoulder flexion.	The change between the first week of index stroke (acute phase) and at 3 months after index stroke
Kinematic metrics: movement pattern	The kinect camera together with the software Akira will be used to automatically measure the pattern of the following movements: trunk oscillation during standing position and during walking; and trunk oscillation during seating position with opened and closed eyes.	The change between the first week of index stroke (acute phase) and at 3 months after index stroke

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship of kinematic measures with the degree of disability after stroke.	Correlation between the kinematic metrics described before (joint angles, movement acceleration and movement pattern) and the degree of disability, measured y the modified Rankin scale. The modified Rankin Scale (mRS) is a extensively use scale to measure dependency after stroke. The minimum value is 0 (no sequels or disability) and the maximum value is 6 (dead). The lower the score in the scale, the better is the outcome.	At 3 months after the index stroke

Collaborators and Investigators

• Sponsor: Instituto de Investigación Hospital Universitario La Paz
• Investigators: Study Director: María Alonso de Leciñana, MD PhD, Hospital Universitario La PAZ, IdiPAZ

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2020
• Primary Completion (Anticipated): January 29, 2021
• Study Completion (Anticipated): June 29, 2021

Study Registration Dates

• First Submitted: June 11, 2020
• First Submitted That Met QC Criteria: July 6, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Actual): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 6, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole
• Other Study ID Numbers: KAM-Study (PI-3787)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No