Cognitive Motion-Based Videogames Exploratory Study in Acquired Brain Injury

Study Overview
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Brief Summary
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This study aims to assess the feasibility of Intendu Cognitive Motion-Based Videogames in Acquired Brain Injury (ABI) patients in inpatient treatment and in the community and to evaluate the effects of training on patients' cognitive performance

Detailed Description
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This study includes three experimental arms to research cognitive video games involving motion interaction in ABI population. The study consists of 4 primary phases: recruitment, assessment, intervention and post-intervention assessment. Two arms involve a randomized controlled study with inpatient participants, where participants are randomly assigned to an intervention or control group. Recruitment phase includes cognitive assessments to evaluate eligibility for the study. In the assessment and post assessment phases cognitive performance is established. Intervention includes 10 computerized training sessions of 30-45 minutes over 3 weeks period using Intendu Functional Brain Trainer (FBT). The control group intervention involves playing commercial iPad games for the same duration. Interventions will be performed in addition to standard inpatient treatment. In addition to the randomized control study, a third experimental arm will be performed, were participants living in the community will perform a similar protocol with cognitive motion-based video games. The recruitment, assessment, post assessment and intervention phases will be similar to the above.

Official Title
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A Study to Assess the Feasibility of Intendu Cognitive Motion-Based Videogames in Acquired Brain Injury Patients and to Evaluate the Effects of Training on Their Cognitive Performance

Conditions
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Acquired Brain Injury

Intervention / Treatment
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* Other: Motion Based Cognitive Video Games Software
* Other: iPad Apps


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with Acquired Brain Injury. At least one functional upper limb. Ability to understand instructions that will be assessed by the therapist. Basic cognitive ability in Orientation, Visual Perception and Spatial Perception. Impairment in Executive Functions (EF) as assessed by EF assessments. normal vision. Exclusion Criteria: Untreated epilepsy Other Psychiatric or Neurological disease. Neglect or Hemianopia. For the Community arm - doesn't receive any cognitive therapy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intendu FBT inpatient<br>Other: Motion Based Cognitive Video Games Software | Other: Motion Based Cognitive Video Games Software<br>* Intendu FBT motion based cognitive video games software<br>|
| Active Comparator: iPad games<br>Other: iPad apps | Other: iPad Apps<br>* Commercially available iPad game applications<br>|
| Experimental: Intendu FBT community<br>Other: Motion Based Cognitive Video Games Software | Other: Motion Based Cognitive Video Games Software<br>* Intendu FBT motion based cognitive video games software<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cognitive Functions | Assessments of cognitive skills as they express in task performance. | Week 0, week 4 | 
| Change in Cognitive Performance Questionnaires | Questionnaire assessing cognitive skills as they express in everyday function. | Week 0, week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Experience during intervention | Questionnaire regarding experience from intervention (e.g. satisfaction, exertion, etc.) following training. | week 4 | 
| Safety - Record of any adverse event | Any adverse event occurring during or following the intervention will be recorded. | Weeks 0-4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive VideoGames