NCT04833088

Brief Summary

This qualitative study aims to identify the needs and recommendations of both patients and healthcare professionals in terms of rehabilitation technology, more specific three pre-defined user scenarios. These scenario were developed based on brainstorm sessions with healthcare professionals from the rehabilitation ward of UZ Brussel and AZ Sint-Maria Halle. The purpose of this study is to create an overview of recommendations that will be used to develop the smart devices in a later stage of the SAIRE project.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 6, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 10, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

July 7, 2022

Status Verified

July 1, 2022

Enrollment Period

10 months

First QC Date

April 1, 2021

Last Update Submit

July 6, 2022

Conditions

StrokeParkinson DiseaseCovid19Neglect, Hemispatial

Outcome Measures

Primary Outcomes (1)

  • Overview of needs and requirements for the development of the three predefined user scenarios

    Recurring themes in the transcribed data of the focus groups will be identified and checked for relevance in terms of the research question (e.g. key functionalities of the device, aesthetic requirements, ...). These relevant themes will then be combined to create an overview for every user scenario individually.

    through study completion, an average of 1 year

Study Arms (4)

Healthcare professionals

OTHER
Other: Focus group discussions

Patients who suffer from spatial neglect

OTHER
Other: Focus group discussions

Patients who have walking difficulties

OTHER
Other: Focus group discussions

Patients who require long term use of an IV-stand

OTHER
Other: Focus group discussions

Interventions

Focus group discussionsOTHER

Focus group discussions will be organized to investigate the needs and requirements of the participants in terms of three pre-defined user scenarios.

Healthcare professionalsPatients who have walking difficultiesPatients who require long term use of an IV-standPatients who suffer from spatial neglect

Eligibility Criteria

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

You may qualify if:

  • adult (≥ 18 years)
  • diagnosed with stroke (as defined by the World Health Organization) and suffering from spatial neglect
  • able to verbally answer questions
  • ability to give informed consent

You may not qualify if:

  • severe cognitive disability (based on assessment of the healthcare professionals)
  • adult (≥ 18 years)
  • suffering from gait problems (e.g. frail elderly, Parkinson Disease, recovering from COVID-19)
  • able to verbally answer questions
  • ability to give informed consent
  • severe cognitive disability (based on assessment of the healthcare professionals)
  • adult (≥ 18 years)
  • requires intensive use of an IV-stand during hospitalisation
  • able to verbally answer questions
  • ability to give informed consent
  • severe cognitive disability (based on assessment of the healthcare professionals)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vrije Universiteit Brussel

Jette, Brussels Capital, 1090, Belgium

Location

MeSH Terms

Conditions

StrokeParkinson DiseaseCOVID-19Perceptual Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParkinsonian DisordersBasal Ganglia DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Eva Swinnen, Prof. Ph.D

    Vrije Universiteit Brussel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The Principal Investigator

Study Record Dates

First Submitted

April 1, 2021

First Posted

April 6, 2021

Study Start

June 10, 2021

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

July 7, 2022

Record last verified: 2022-07

Locations

BE(1)