Cognitive Motion-Based Videogames Exploratory Study in Acquired Brain Injury

NCT ID: NCT02753244

Last Updated: 2018-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

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.

Conditions

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Acquired Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intendu FBT inpatient

Other: Motion Based Cognitive Video Games Software

Group Type EXPERIMENTAL

Motion Based Cognitive Video Games Software

Intervention Type OTHER

Intendu FBT motion based cognitive video games software

iPad games

Other: iPad apps

Group Type ACTIVE_COMPARATOR

iPad Apps

Intervention Type OTHER

Commercially available iPad game applications

Intendu FBT community

Other: Motion Based Cognitive Video Games Software

Group Type EXPERIMENTAL

Motion Based Cognitive Video Games Software

Intervention Type OTHER

Intendu FBT motion based cognitive video games software

Interventions

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Motion Based Cognitive Video Games Software

Intendu FBT motion based cognitive video games software

Intervention Type OTHER

iPad Apps

Commercially available iPad game applications

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel Aviv University

OTHER

Sponsor Role collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role collaborator

Loewenstein Hospital

OTHER

Sponsor Role collaborator

Intendu Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ofer Keren, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Yaron Sacher, MD

Role: PRINCIPAL_INVESTIGATOR

Loewenstein Hospital

Locations

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Traumatic Brain Injury department, Loewenstein Hospital

Raanana, , Israel

Site Status RECRUITING

The Sheba Rehabilitation Hospital, The Head Trauma Rehabilitation Department

Ramat Gan, , Israel

Site Status NOT_YET_RECRUITING

Countries

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Israel

Central Contacts

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Son Preminger, PhD

Role: CONTACT

+972-9-7992240

Sivan Maoz, BOT

Role: CONTACT

+972-9-7992240

Facility Contacts

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Yaron Sacher, MD

Role: primary

+972-9-7709920

Rotem Eliav, BOT

Role: backup

Ofer Keren, MD

Role: primary

+972-3-5305158

Elena Tchvaloon, MD

Role: backup

+972-3-5305158

Other Identifiers

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2215 - 15 - SMC

Identifier Type: OTHER

Identifier Source: secondary_id

00070-001

Identifier Type: -

Identifier Source: org_study_id

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