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| ID | Type | Description | Link |
|---|---|---|---|
| 2215 - 15 - SMC | Other Identifier | Sheba Medical Center |
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| Name | Class |
|---|---|
| Tel Aviv University | OTHER |
| Sheba Medical Center | OTHER_GOV |
| Loewenstein Hospital | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intendu FBT inpatient | Experimental | Other: Motion Based Cognitive Video Games Software |
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| iPad games | Active Comparator | Other: iPad apps |
|
| Intendu FBT community | Experimental | Other: Motion Based Cognitive Video Games Software |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motion Based Cognitive Video Games Software | Other | Intendu FBT motion based cognitive video games software |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Son Preminger, PhD | Contact | +972-9-7992240 | son@intendu.com | |
| Sivan Maoz, BOT | Contact | +972-9-7992240 | sivan@intendu.com |
| Name | Affiliation | Role |
|---|---|---|
| Ofer Keren, MD | Sheba Medical Center | Principal Investigator |
| Yaron Sacher, MD | Loewenstein Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Traumatic Brain Injury department, Loewenstein Hospital | Recruiting | Raanana | 43100 | Israel |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| iPad Apps | Other | Commercially available iPad game applications |
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| Weeks 0-4 |
| The Sheba Rehabilitation Hospital, The Head Trauma Rehabilitation Department | Not yet recruiting | Ramat Gan | 5262100 | Israel |
|
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |