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Clinical Trial of a Rehabilitation Game - SuperBetter

This study is currently recruiting participants.
Verified October 2012 by Ohio State University
Sponsor:
Information provided by (Responsible Party):
Lise Worthen-Chaudhari, Ohio State University
ClinicalTrials.gov Identifier:
NCT01398566
First received: July 19, 2011
Last updated: October 16, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention Phase
Concussion
Mild Traumatic Brain Injury
Moderate Traumatic Brain Injury
 Behavioral: SuperBetter play
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Clinical Trial of a Novel Rehabilitation Game (Phase I - Feasibility)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Community participation measures [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    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:
  • Quality of Life Scale for both patient & primary support giver [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 25 Years
Genders Eligible for Study:   Both
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398566

Contacts
Contact: Lise Worthen-Chaudhari, MFA, MS 614-293-6281 lise.worthen-chaudhari@osumc.edu
Contact: Ohio State Research Hotline 614-293-HERO

Locations
United States, Ohio
The Ohio State University Physical Medicine and Rehabilitation Department Recruiting
Columbus, Ohio, United States, 43210
Contact: Lise Worthen-Chaudhari, MFA, MS     614-293-6281     lise.worthen-chaudhari@osumc.edu    
Contact: Ohio State Research Hotline     614-293-HERO        
Principal Investigator: W Mysiw, MD            
Sub-Investigator: Lise Worthen-Chaudhari, MFA, MS            
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Lisa Worthen-Chaudhari, MFA,MS,CCRC Ohio State University
  More Information

Additional Information:
Sponsor website  This link exits the ClinicalTrials.gov site
Game designer website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Lise Worthen-Chaudhari, Research Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT01398566     History of Changes
Other Study ID Numbers: 2011H0077
Study First Received: July 19, 2011
Last Updated: October 16, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Ohio State University:
TBI
concussion
brain injury

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013