NCT04291586

Brief Summary

Virtual Reality allows the integration of cognitive rehabilitation in a more ecologically valid context. The purpose of this study is to determine whether this methodology has more impact on psychosocial rehabilitation than a paper and pencil personalized program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

June 3, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2020

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 2, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

January 6, 2021

Status Verified

January 1, 2021

Enrollment Period

8 months

First QC Date

May 24, 2019

Last Update Submit

January 5, 2021

Conditions

Psychiatric Disease

Keywords

Virtual RealityCognitive RehabilitationPsychosocial RehabilitationEcological validityPersonalization

Outcome Measures

Primary Outcomes (1)

  • Montreal Cognitive Assessment (Cognitive Screening)

    Change from baseline in the Montreal Cognitive Assessment. Higher values represent better outcomes.

    Baseline, End (8 weeks) and 8-weeks follow-up

Secondary Outcomes (6)

  • Toulouse-Pieron (Attention)

    Baseline, End (8 weeks) and 8-weeks follow-up

  • Semantic Fluency and Phonemic Fluency Tests

    Baseline, End (8 weeks) and 8-weeks follow-up

  • Verbal Paired Associates (WMS-III) (Memory)

    Baseline, End (8 weeks) and 8-weeks follow-up

  • Rey Complex Figure

    Baseline, End (8 weeks) and 8-weeks follow-up

  • Symbol Search and Coding (WAIS III)

    Baseline, End (8 weeks) and 8-weeks follow-up

  • +1 more secondary outcomes

Other Outcomes (4)

  • Beck Depression Inventory - II

    Baseline, End (8 weeks) and 8-weeks follow-up

  • Barthel Index

    Baseline, End (8 weeks) and 8-weeks follow-up

  • Katz Index

    Baseline, End (8 weeks) and 8-weeks follow-up

  • +1 more other outcomes

Study Arms (2)

Virtual Reality

EXPERIMENTAL

The Virtual Reality group will perform personalized activities of daily living in the context of a simulated city (Reh@City). The interaction with the virtual environment will be through a natural user interface.

Other: Virtual reality

Paper and Pencil

ACTIVE COMPARATOR

The paper and pencil group will perform a set of cognitive paper and pencil tasks personalized to their deficits and generated automatically through a Task Generator.

Other: Paper and Pencil

Interventions

Virtual realityOTHER

Virtual Reality Intervention of 30 minutes, 3 times a week until reaching 24 sessions.

Virtual Reality
Paper and PencilOTHER

Paper and Pencil Intervention of 30 minutes, 3 times a week until reaching 24 sessions.

Paper and Pencil

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Inpatients of psychosocial rehabilitation unit;
  • Cognitive deficit but with enough capacity to understand the task and follow instructions;
  • Able to read and write.

You may not qualify if:

  • Patients experiencing an acute psychiatric episode.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto das Irmãs Hospitaleiras do Sagrado Coração de Jesus - Casa de Saúde Câmara Pestana

Funchal, Funchal-Madeira, 9060-021, Portugal

Location

MeSH Terms

Conditions

Mental Disorders

Interventions

Paper

Intervention Hierarchy (Ancestors)

Manufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Sergi Bermudez, Ph,D

    Madeira Interactive Technologies Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2019

First Posted

March 2, 2020

Study Start

June 3, 2019

Primary Completion

February 7, 2020

Study Completion

March 31, 2020

Last Updated

January 6, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)