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

Recruiting

Phase N/A Results N/A

Trial Description

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.

Detailed Description

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.

Conditions

Interventions

  • Virtual Reality Device
    Intervention Desc: Virtual reality based upper-limb motor and cognitive task
    ARM 1: Kind: Experimental
    Label: VR motor-cognitive task
    Description: 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.
  • Standard Behavioral
    Intervention Desc: Standard upper-limb motor and cognitive rehabilitation tasks
    ARM 1: Kind: Experimental
    Label: Standard rehabilitation
    Description: The standard rehabilitation group will perform conventional motor and cognitive rehabilitation tasks.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from baseline in the Fugl-Meyer Assessment Test (upper extremity) Baseline, End (4-6 weeks) and 4-weeks follow-up No
Primary Change form baseline in the Chedoke Arm and Hand Activity Inventory Baseline, End (4-6 weeks) and 4-weeks follow-up No
Primary Change from baseline in the Montreal Cognitive Assessment Baseline, End (4-6 weeks) and 4-weeks follow-up No
Secondary Change from baseline in the Barthel Index Baseline, End (4-6 weeks) and 4-weeks follow-up No
Secondary Change from baseline in the Modified Ashworth Scale Baseline, End (4-6 weeks) and 4-weeks follow-up No
Secondary Change from baseline in the Motricity Index (upper extremity) Baseline, End (4-6 weeks) and 4-weeks follow-up No
Secondary Change from baseline in cancellation tests (single letter, number, bells) Baseline, End (4-6 weeks) and 4-weeks follow-up No

Sponsors