A Randomised Controlled Trial Comparing the Impact of Virtual Reality, Paper and Pencil and Conventional Methods on Stroke Rehabilitation
NCT ID: NCT02857803
Last Updated: 2019-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
42 participants
INTERVENTIONAL
2016-06-30
2019-01-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Virtual Reality Rehabilitation Protocol for Sensory-motor Rehabilitation After a Stoke
NCT06164054
The Effect of Virtual Reality-Mediated Rehabilitation in Ischemic Stroke Patients
NCT05869786
Using Immersive Virtual Reality for the Upper Limb Rehabilitation of Post-stroke Subjects
NCT06892886
Effect of Robotic Therapy on Upper Extremity With Stroke
NCT05815823
Immersive Virtual Reality Based Training for Rehabilitation of Subacute Stroke
NCT03086889
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Through a participatory design approach, with health professionals, the investigators have developed:
* a motor-accessible and cognitive-personalized VR-based system, where conventional cognitive tasks were operationalized in meaningful simulations of ADL's (Reh@City) and;
* a web tool which generates personalised paper and pencil tasks( Task Generator).
The investigators objective is to have a sample of 60 stroke patients between 40 and 70 years old, randomly allocated in three groups: the experimental group 1 were participants will perform 30 minutes of the VR training with Reh@City; the experimental group 2 were participants will perform 30 minutes of the paper and pencil training with the Task Generator, and the control group were participants will perform 30 minutes of conventional therapy (occupational therapy).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Virtual Reality
The Virtual Reality group will perform personalised 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.
Virtual Reality
Intervention of 30 minutes, 3 times a week until reaching 12 sessions.
Paper and Pencil
The paper and pencil group will perform a set of cognitive paper and pencil tasks personalised to their deficits and generated automatically through a Task Generator.
Paper and Pencil
Intervention of 30 minutes, 3 times a week until reaching 12 sessions.
Conventional Therapy
The Conventional Therapy group will perform the activities offered by the public health system, which are motor-focused.
Conventional Therapy
Intervention of 30 minutes, 3 times a week until reaching 12 sessions.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Virtual Reality
Intervention of 30 minutes, 3 times a week until reaching 12 sessions.
Paper and Pencil
Intervention of 30 minutes, 3 times a week until reaching 12 sessions.
Conventional Therapy
Intervention of 30 minutes, 3 times a week until reaching 12 sessions.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* cognitive deficit but with enough capacity to understand the task and follow instructions with a minimum score of 11 over 17 in the Token Test (6-item version, Portuguese population)
* able to read and write
Exclusion Criteria
* Severe depressive symptoms as assessed by the Beck Depression Inventory
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Serviço de Saúde da Região Autónoma da Madeira (SESARAM), E.P.E.
UNKNOWN
Universidade da Madeira
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sergi Bermúdez i Badia
Professor Auxiliar
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sergi Bermudez i Badia, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidade da Madeira
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Serviço de Saúde da Região Autónoma da Madeira
Funchal, Madeira, Portugal
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Faria, A. L., & Bermúdez i Badia, S. (2015). Development and evaluation of a web-based cognitive task generator for personalized cognitive training: a proof of concept study with stroke patients. In REHAB 2015: 3rd Workshop on ICTs for improving Patients Research Techniques. ACM.
Faria, A. L., Vourvopoulos, A., Cameirão, M. S., Fernandes, J. C., & Bermúdez i Badia, S. (2014). An integrative virtual reality cognitive-motor intervention approach in stroke rehabilitation: a pilot study. In 10th ICDVRAT, Gothenburg, Sweden, Sept. 2-4, 2014.
Vourvopoulos, A., Faria, A. L., Ponnam, K., & Bermúdez i Badia, S. (2014). RehabCity: Design and Validation of a Cognitive Assessment and Rehabilitation Tool through Gamified Simulations of Activities of Daily Living. In 11th International Conference on Advances in Computer Entertainment Technology. Funchal, Portugal.
Faria AL, Pinho MS, Bermudez I Badia S. A comparison of two personalization and adaptive cognitive rehabilitation approaches: a randomized controlled trial with chronic stroke patients. J Neuroeng Rehabil. 2020 Jun 16;17(1):78. doi: 10.1186/s12984-020-00691-5.
Related Links
Access external resources that provide additional context or updates about the study.
Task Generator
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
303891
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.