NCT02539914

Brief Summary

The purpose of this study is to determine whether it is feasible to use a virtual reality task for stroke rehabilitation for training motor and cognitive (attention and memory) domains based on the use of positive stimuli, and to evaluate the potential benefits in comparison to standard rehabilitation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jun 2015

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

Study Start

First participant enrolled

June 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 3, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 7, 2017

Status Verified

March 1, 2017

Enrollment Period

1.5 years

First QC Date

August 27, 2015

Last Update Submit

March 4, 2017

Conditions

Stroke

Keywords

Virtual realityMotor and cognitive rehabilitationPositive emotion stimuli

Outcome Measures

Primary Outcomes (3)

  • Change from baseline in the Fugl-Meyer Assessment Test (upper extremity)

    Assessment of change from baseline in motor and joint functioning of the paretic upper extremity.

    Baseline, End (4-6 weeks) and 4-weeks follow-up

  • Change form baseline in the Chedoke Arm and Hand Activity Inventory

    Assessment of change from baseline in the functionality of the paretic upper extremity.

    Baseline, End (4-6 weeks) and 4-weeks follow-up

  • Change from baseline in the Montreal Cognitive Assessment

    Assessment of change from baseline in cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.

    Baseline, End (4-6 weeks) and 4-weeks follow-up

Secondary Outcomes (4)

  • Change from baseline in the Barthel Index

    Baseline, End (4-6 weeks) and 4-weeks follow-up

  • Change from baseline in the Modified Ashworth Scale

    Baseline, End (4-6 weeks) and 4-weeks follow-up

  • Change from baseline in the Motricity Index (upper extremity)

    Baseline, End (4-6 weeks) and 4-weeks follow-up

  • Change from baseline in cancellation tests (single letter, number, bells)

    Baseline, End (4-6 weeks) and 4-weeks follow-up

Study Arms (2)

VR motor-cognitive task

EXPERIMENTAL

The VR motor-cognitive task group will perform a virtual reality motor and cognitive attention/memory task customized to each user in terms of the positive content.

Other: Virtual Reality

Standard rehabilitation

ACTIVE COMPARATOR

The standard rehabilitation group will perform conventional motor and cognitive rehabilitation tasks.

Other: Standard

Interventions

Virtual RealityOTHER

Virtual reality based upper-limb motor and cognitive task

VR motor-cognitive task
StandardOTHER

Standard upper-limb motor and cognitive rehabilitation tasks

Standard rehabilitation

Eligibility Criteria

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

You may qualify if:

  • ischemic or hemorrhagic stroke within the first 6 months post-stroke
  • motor impairment of the upper extremity but with a minimum score of 28 in the Motricity Index (elbow flexion and shoulder abduction domains combined score)
  • 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

You may not qualify if:

  • previous motor and/or cognitive deficits
  • normal cognitive functioning with a score above 26 points in the Montreal Cognitive Assessment
  • unilateral spatial neglect
  • moderate to severe depressive symptomatology with a score above 20 points in the Geriatric Depression Scale
  • vision disorders that may interfere with the execution of the task

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SESARAM

Funchal, Madeira, 9000-012, Portugal

Location

Related Publications (1)

  • Cameirao MS, Faria AL, Paulino T, Alves J, Bermudez I Badia S. The impact of positive, negative and neutral stimuli in a virtual reality cognitive-motor rehabilitation task: a pilot study with stroke patients. J Neuroeng Rehabil. 2016 Aug 9;13(1):70. doi: 10.1186/s12984-016-0175-0.

    PMID: 27503215BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Sergi Bermudez i Badia, PhD

    Universidade da Madeira

    PRINCIPAL INVESTIGATOR

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 27, 2015

First Posted

September 3, 2015

Study Start

June 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 7, 2017

Record last verified: 2017-03

Locations

PT(1)