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

Stroke Clinical Trial

— KAM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04464863
• Other study ID #: KAM-Study (PI-3787)
• Status: Recruiting
• Start date: January 29, 2020
• Est. completion date: June 29, 2021

Study information

• Verified date: April 2020
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: María Alonso de Leciñana, MD PhD
• Phone: +34 917 277 444
• Email: malecinanacases[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: June 29, 2021
• Est. primary completion date: January 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Kinematic metrics
kinematic metrics recorded with Kinect (register brand) and extracted with Akira (register brand)

Locations

Country	Name	City	State
Spain	La Paz University Hospital, IdiPAZ	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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