A Randomised Controlled Trial Comparing the Impact of Virtual Reality, Paper and Pencil and Conventional Methods on Stroke Rehabilitation
The Impact of Using an Interactive System, a Paper and Pencil Program or Conventional Methodologies in the Rehabilitation of Stroke Patients: a Randomised Controlled Trial
1 other identifier
interventional
42
1 country
1
Brief Summary
Virtual Reality allows the integration of both cognitive and motor rehabilitation in a more ecologically valid context. The purpose of this study is to determine whether this methodology has more impact on stroke rehabilitation than a paper and pencil personalised program and conventional therapy, which is motor-focused.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Jun 2016
Typical duration for not_applicable stroke
1 active site
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
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 3, 2016
CompletedFirst Posted
Study publicly available on registry
August 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2019
CompletedOctober 15, 2019
October 1, 2019
2.6 years
August 3, 2016
October 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in the Montreal Cognitive Assessment
Baseline, End (4-6 weeks) and 8-weeks follow-up
Secondary Outcomes (4)
Change from baseline in the Trail Making Test A and B
Baseline, End (4-6 weeks) and 8-weeks follow-up
Change from baseline in the Verbal Paired Associates (WMS III)
Baseline, End (4-6 weeks) and 8-weeks follow-up
Change from baseline in the Digit Span (WAIS III)
Baseline, End (4-6 weeks) and 8-weeks follow-up
Change from baseline in the Symbol Search and Coding (WAIS III)
Baseline, End (4-6 weeks) and 8-weeks follow-up
Other Outcomes (1)
Crystallised Intelligence as assesed by Comprehension from the WAIS III
Baseline
Study Arms (3)
Virtual Reality
EXPERIMENTALThe 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.
Paper and Pencil
ACTIVE COMPARATORThe 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.
Conventional Therapy
ACTIVE COMPARATORThe Conventional Therapy group will perform the activities offered by the public health system, which are motor-focused.
Interventions
Intervention of 30 minutes, 3 times a week until reaching 12 sessions.
Intervention of 30 minutes, 3 times a week until reaching 12 sessions.
Intervention of 30 minutes, 3 times a week until reaching 12 sessions.
Eligibility Criteria
You may qualify if:
- ischemic stroke with more than 6 months post-stroke
- 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
You may not qualify if:
- Neglect
- Severe depressive symptoms as assessed by the Beck Depression Inventory
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Serviço de Saúde da Região Autónoma da Madeira
Funchal, Madeira, 9004-514, Portugal
Related Publications (4)
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.
BACKGROUNDFaria, 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.
BACKGROUNDVourvopoulos, 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.
BACKGROUNDFaria 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.
PMID: 32546251DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sergi Bermudez i Badia, PhD
Universidade da Madeira
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Auxiliar
Study Record Dates
First Submitted
August 3, 2016
First Posted
August 5, 2016
Study Start
June 1, 2016
Primary Completion
January 8, 2019
Study Completion
January 10, 2019
Last Updated
October 15, 2019
Record last verified: 2019-10