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Clinical Trial of a Rehabilitation Game - SuperBetter (SuperBetter)

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ClinicalTrials.gov Identifier: NCT01398566
Recruitment Status : Completed
First Posted : July 20, 2011
Last Update Posted : April 10, 2015
Sponsor:
Information provided by (Responsible Party):
Lise Worthen-Chaudhari, Ohio State University

Brief Summary:

Today's hospitals need innovative solutions to help patients transition from our care to self-management at home. The vast majority of the patients seen in Dodd Rehabilitation Hospital and associated clinics leave our care with persistent and life-altering challenges - behavioral, cognitive, emotional and/or physical. The period of time immediately following discharge is an under-addressed stage within the continuum of care. The investigators are researching solutions to help patients in this transition to self-care and believe that multiplayer gaming paradigms may be a promising innovation to facilitate this transition.

The investigators believe that Dr. Jane McGonigal's SuperBetter, and positive play games like it, are promising novel interventions that could make a positive difference in the ability of our patients to successfully transition to self care after discharge from therapeutic care.

Specifically, the investigators will evaluate feasibility of use of such a game by mild to moderate brain injured individuals and to record pilot data to help us plan a clinical effectiveness follow up study. Our goal is to finish this study with an intervention tailored for use within the clinical continuum of care and sufficient pilot data to prepare for a randomized clinical control trial of this intervention.


Condition or disease Intervention/treatment Phase
Concussion Mild Traumatic Brain Injury Moderate Traumatic Brain Injury Behavioral: SuperBetter play Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Clinical Trial of a Novel Rehabilitation Game (Phase I - Feasibility)
Study Start Date : May 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Gaming
members of this group will play SuperBetter for 6 weeks (averaging 10 min per day of play for 6 week period)
Behavioral: SuperBetter play
average 10 min of game play per day for 6 week period




Primary Outcome Measures :
  1. Community participation measures [ Time Frame: 2 weeks ]
    Does this web-based, multi-player game enhance or hinder community participation among individuals recovering from concussion (mild to moderate traumatic brain injury)?


Secondary Outcome Measures :
  1. Quality of Life Scale for both patient & primary support giver [ Time Frame: 2 weeks ]
    Do patient and/or support giver report that quality of life is reduced, improved, or stays the same over the course of participation in this gaming intervention.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients: between 15 and 25 years old
  • diagnosed within the last year with at least one traumatic brain injury (mild or moderate)
  • subjective report of less than complete recovery from the injury
  • easy access to computer with internet access
  • compatible web browser (such as the latest version of Internet Explorer, Chrome, Firefox or other as determined by developers)
  • has a support giver (18 or over) who is willing to participate in this study also

Exclusion Criteria:

● history of substance abuse as self reported by patient or reported by support giver


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01398566


Locations
United States, Ohio
The Ohio State University Physical Medicine and Rehabilitation Department
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Lise Worthen-Chaudhari, MFA,MS,CCRC Ohio State University

Additional Information:
Responsible Party: Lise Worthen-Chaudhari, Research Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT01398566     History of Changes
Other Study ID Numbers: 2011H0077
First Posted: July 20, 2011    Key Record Dates
Last Update Posted: April 10, 2015
Last Verified: April 2015

Keywords provided by Lise Worthen-Chaudhari, Ohio State University:
TBI
concussion
brain injury

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating