Cognitive Motion-Based Videogames Exploratory Study in Acquired Brain Injury
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
2 other identifiers
interventional
50
1 country
2
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 10, 2016
CompletedFirst Posted
Study publicly available on registry
April 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedMarch 1, 2018
February 1, 2018
3.2 years
April 10, 2016
February 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Experience during intervention
week 4
Safety - Record of any adverse event
Weeks 0-4
Study Arms (3)
Intendu FBT inpatient
EXPERIMENTALOther: Motion Based Cognitive Video Games Software
iPad games
ACTIVE COMPARATOROther: iPad apps
Intendu FBT community
EXPERIMENTALOther: Motion Based Cognitive Video Games Software
Interventions
Intendu FBT motion based cognitive video games software
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Untreated epilepsy
- Other Psychiatric or Neurological disease.
- Neglect or Hemianopia.
- For the Community arm - doesn't receive any cognitive therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Intendu Ltd.lead
- Tel Aviv Universitycollaborator
- Sheba Medical Centercollaborator
- Loewenstein Hospitalcollaborator
Study Sites (2)
Traumatic Brain Injury department, Loewenstein Hospital
Raanana, 43100, Israel
The Sheba Rehabilitation Hospital, The Head Trauma Rehabilitation Department
Ramat Gan, 5262100, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ofer Keren, MD
Sheba Medical Center
- PRINCIPAL INVESTIGATOR
Yaron Sacher, MD
Loewenstein Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2016
First Posted
April 27, 2016
Study Start
April 1, 2015
Primary Completion
June 1, 2018
Last Updated
March 1, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share