Cognitive Motion-Based Videogames Exploratory Study in Acquired Brain Injury

I

Intendu

Status

Unknown

Conditions

Acquired Brain Injury

Treatments

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

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

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

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

Trial contacts and locations

2

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Central trial contact

Son Preminger, PhD; Sivan Maoz, BOT

Data sourced from clinicaltrials.gov

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