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Completed

NCT Number: NCT02539914

Feasibility Study of a Virtual Reality Cognitive-motor Task Based on Positive Stimuli for Stroke Rehabilitation

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SESARAM

Funchal, Madeira, 9000-012, Portugal

About this study

There is evidence that positive emotion stimuli can lead to improved performance in attention tasks and the investigators aim to understand the benefits of using this principle in cognitive and upper-limb motor rehabilitation following stroke. For this purpose, the investigators developed a VR attention task in which the user has to find a target image within a variable number of distractors by controlling a virtual arm. In some levels of the task the target has to be memorized, hence training both attention and memory. The target stimuli are positive images based on the individual preferences of each user.

40 participants within the first 6 months after stroke will be randomly allocated to one of two groups: 1) VR motor-cognitive task or 2) standard rehabilitation. The VR motor-cognitive task group will use the above described virtual task customized to each user in terms of the positive content. This also includes selected music that will be introduced in half of the sessions. The standard rehabilitation group will undergo conventional motor and cognitive rehabilitation. The intervention consists of 12 sessions of 45 minutes administered within a 4-6 weeks period. The participants will be evaluated using a number motor and cognitive assessment scales at baseline, end of the intervention and a 1-month follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Virtual Reality

Other

Virtual reality based upper-limb motor and cognitive task

standard

Other

Standard upper-limb motor and cognitive rehabilitation tasks

Primary outcomes

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

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

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

  2. Change form baseline in the Chedoke Arm and Hand Activity Inventory

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

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

  3. Change from baseline in the Montreal Cognitive Assessment

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

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

Secondary outcomes

  1. Change from baseline in the Barthel Index

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

    Assessment of change from baseline in independence in activities of daily living.

  2. Change from baseline in the Modified Ashworth Scale

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

    Assessment of change from baseline in muscle spasticity of the upper extremity

  3. Change from baseline in the Motricity Index (upper extremity)

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

    Assessment of change from baseline in muscle power of the paretic upper extremity.

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

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

    Assessment of change from baseline in visual scanning deficits

Sponsors and collaborators

Lead sponsor

Universidade da Madeira

Other

Collaborators

  • Serviço de Saúde da Região Autónoma da Madeira (SESARAM), E.P.E.

Registry information

Official study title

Interactive System for Diagnostics and Rehabilitation of Cognitive-motor Deficits: Controlled Longitudinal Clinical Study With Stroke Patients

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 3, 2015
Registry last updated
Mar 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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