Cognitive Motion-Based Videogames Exploratory Study in Acquired Brain Injury

Intendu

Status: Unknown

Conditions: Acquired Brain Injury

Treatments: Other: Motion Based Cognitive Video Games Software; Other: iPad Apps

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02753244

00070-001

2215 - 15 - SMC (Other Identifier)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosed with Acquired Brain Injury.
2. At least one functional upper limb.
3. Ability to understand instructions that will be assessed by the therapist.
4. Basic cognitive ability in Orientation, Visual Perception and Spatial Perception.
5. Impairment in Executive Functions (EF) as assessed by EF assessments.
6. normal vision.

Exclusion criteria

1. Untreated epilepsy
2. Other Psychiatric or Neurological disease.
3. Neglect or Hemianopia.
4. For the Community arm - doesn't receive any cognitive therapy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 3 patient groups

Intendu FBT inpatient

Experimental group

Description:

Other: Motion Based Cognitive Video Games Software

Treatment:

Other: Motion Based Cognitive Video Games Software

iPad games

Active Comparator group

Description:

Other: iPad apps

Treatment:

Other: iPad Apps

Intendu FBT community

Experimental group

Description:

Other: Motion Based Cognitive Video Games Software

Treatment:

Other: Motion Based Cognitive Video Games Software