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

July 6, 2020 updated by: Instituto de Investigación Hospital Universitario La Paz
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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Spain
      • Madrid, Spain, 28046
        • Recruiting
        • La Paz University Hospital, IdiPAZ
        • Sub-Investigator:
          • Silvia Pastor Yvorra
        • Contact:
        • Contact:
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Kinematic metrics: join angles
Time Frame: The change between the first week of index stroke (acute phase) and at 3 months after index stroke
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
Time Frame: The change between the first week of index stroke (acute phase) and at 3 months after index stroke
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
Time Frame: The change between the first week of index stroke (acute phase) and at 3 months after index stroke
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Relationship of kinematic measures with the degree of disability after stroke.
Time Frame: At 3 months after the index 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Instituto de Investigación Hospital Universitario La Paz

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: María Alonso de Leciñana, MD PhD, Hospital Universitario La PAZ, IdiPAZ

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 29, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 29, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 29, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 9, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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