NCT04464863

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 29, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2021

Completed
Last Updated

July 9, 2020

Status Verified

April 1, 2020

Enrollment Period

1 year

First QC Date

June 11, 2020

Last Update Submit

July 6, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Relationship of kinematic measures with the degree of disability after stroke.

    At 3 months after the index stroke

Study Arms (2)

Cases

Acute stroke patients during the first week of evolution

Other: Kinematic metrics

Control

Age and sex 1:1 healthy participants

Other: Kinematic metrics

Interventions

kinematic metrics recorded with Kinect (register brand) and extracted with Akira (register brand)

CasesControl

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Acute stroke patients and healthy controls, matched by age and sex. The inclusion and exclusion criteria are defined below

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

La Paz University Hospital, IdiPAZ

Madrid, 28046, Spain

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • María Alonso de Leciñana, MD PhD

    Hospital Universitario La Paz, IdiPAZ

    STUDY DIRECTOR

Central Study Contacts

María Alonso de Leciñana, MD PhD

CONTACT

Raquel Gutiérrez Zúñiga, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2020

First Posted

July 9, 2020

Study Start

January 29, 2020

Primary Completion

January 29, 2021

Study Completion

June 29, 2021

Last Updated

July 9, 2020

Record last verified: 2020-04

Locations