NCT05295654

Brief Summary

The aim of this research is to investigate the validity of the Kinect™ sensor in post-stroke patients and in healthy test subjects during analytic and functional movements. Measurements will be compared with the Vicon-camera system (currently seen as the golden standard).

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
50

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable stroke

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

First Submitted

Initial submission to the registry

March 15, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 25, 2022

Completed
20 days until next milestone

Study Start

First participant enrolled

April 14, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 19, 2022

Status Verified

October 1, 2022

Enrollment Period

2.7 years

First QC Date

March 15, 2022

Last Update Submit

October 18, 2022

Conditions

Keywords

KinectValidityVicon

Outcome Measures

Primary Outcomes (2)

  • 3D kinematic measurements lower limb

    Kinematic data (i.e. movement amplitudes of the bilateral hip, knee and ankle joint in degrees) of the lower limbs during the movements will be recorded continuously with the use of the VICON Vero 1.3 system at 100 Hz.

    through study completion, an average of 1 year

  • 3D kinematic measurements upper limb

    Kinematic data (i.e. movement amplitudes of the head, neck, spine, thorax and bilateral shoulder, elbow and wrist joint in degrees) of the lower limbs during the movements will be recorded continuously with the use of the VICON Vero 1.3 system at 100 Hz.

    through study completion, an average of 1 year

Study Arms (1)

Kinect validation

EXPERIMENTAL

Kinect measurements will be compared with the vicon measurements to validate the kinect system.

Other: Kinect validation

Interventions

Participants will perform several movements while both the vicon and kinect are measuring.

Kinect validation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • People post-stroke or healthy test subjects
  • Language: Dutch, English or French
  • Age ≥ 18
  • Able to sit and stand unsupported for 30 s or more
  • Able to stand up from a chair without aid of another person
  • Able to signal pain, fear of discomfort
  • Able to give informed consent (based on the advice of a medical doctor)
  • Able to understand and perform the instructions and to answer questions

You may not qualify if:

  • Concurrent orthopedic and/or musculoskeletal pathologies or disorders that may limit the range of motion (including limb amputations)
  • Concurrent neurological disorders (e.g. Parkinson's Disease, Multiple Sclerosis or Amyotrophic Lateral Sclerosis)
  • Persons with comorbidity that could hinder the study (e.g. unstable cardiovascular system disorders, lung disorders, severe osteoporosis)
  • People with difficulties of speech and/or memory providing that instruction cannot be followed or understood adequate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brubotics Rehabilitation Research Center

Brussels, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Eva Swinnen, Prof. Ph.D

    Vrije Universiteit Brussel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Swinnen, Prof. Ph.D

CONTACT

Emma De Keersmaecker

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 15, 2022

First Posted

March 25, 2022

Study Start

April 14, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

October 19, 2022

Record last verified: 2022-10

Locations