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Clinical Trial of a Rehabilitation Game - SuperBetter

Clinical Trial of a Novel Rehabilitation Game (Phase I - Feasibility)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01398566
Acronym
SuperBetter
Enrollment
20
Registered
2011-07-20
Start date
2014-05-31
Completion date
2015-01-31
Last updated
2021-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Concussion, Mild Traumatic Brain Injury, Moderate Traumatic Brain Injury

Keywords

TBI, concussion, brain injury

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.

Detailed description

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 for several reasons: 1. Games can bring the power of social networks and alternate reality to bear on the real world work of post-injury self-management. 2. Games can use a digital platform, enabling quantification of performance in ways that could provide clinically-relevant documentation for post-discharge follow up efforts including tele-rehabilitation. 3. Today's youth are gamers. The investigators aim to tailor our rehabilitative approaches to leverage the existing ability of our youth in this paradigm. In addition, Dr. Jane McGonigal reports in her book, Reality is Broken, that within another decade the majority of the world's population will likely be gamers. The investigators aim to anticipate this shift and be ready for it. 4. Affordable games have the potential to be cost-effective aids and improvements over standard medical care protocols. Despite the promise of games to facilitate transitions from hospital care to self care, no clinical studies have been done to establish best practices for applying gaming for rehabilitative purposes within the specific window of time in which discharge from standard care happens. While some commercially available games exist for those interested in health self-improvement, through companies such as That Game Company, Nintendo, Xbox, only the Nintendo Wii system has undergone clinical testing to demonstrate feasibility of use within the hospital-based model of patient care. Without more such evidence, the investigators are unable to confidently offer such novel interventions for our patients. A new game, SuperBetter (SuperBetter, LLC, Sausilito, CA), has been developed to employ both social networking and alternate reality theory to achieve rehabilitative goals. SuperBetter is most similar to Facebook or Twitter in that users, or gamers, create an account, invite others to be within their network, and post short status update messages. There are two major differences between SuperBetter and Twitter or Facebook, however. One difference is that this rehabilitation game will not offer a public option. The only people who can see a user's posts and status updates will have been specifically invited by that gamer; people outside the invited network will have no ability to friend a gamer, meaning there is no way to request to become part of a user's network - you must be invited by the account holder. The second difference is that SuperBetter assigns points to a gamer for attaining health goals such as: remembering to take medications each day; avoiding circumstances that exacerbate symptoms; checking in with someone within your trusted network (i.e. reaching out to your loved ones for support). Points are also assigned for epic wins which are defined by the patient and amount to things he or she cannot do today but want to be able to do tomorrow; this includes short term wins like hanging out with friends/loved ones or long term wins like getting back to playing sports. The investigators believe that 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. The investigators are conducting Phase I clinical testing (feasibility) to determine whether such a rehabilitation game is appropriate for use with: mild traumatic brain injured children and teens. Specifically, the investigators will evaluate feasibility of use of such a game by mild traumatic 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.

Interventions

BEHAVIORALSuperBetter play

average 10 min of game play per day for 6 week period

Sponsors

Ohio State University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 25 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Participation8 weeksNumber of Participants who used the app and returned for post testing

Secondary

MeasureTime frameDescription
Satisfaction With App8 weeksSatisfaction rating on a 7 point Likert scale ranging from 1 (very satisfied) to 7 (very dissatisfied) among those who used the app and returned for post testing

Countries

United States

Participant flow

Recruitment details

Clinic patients (aged 13-18 years) with physician-diagnosed concussion and unresolved symptoms at 3 weeks to 12 months post injury between 13 August 2014 and 9 December 2014 were screened and recruited.

Pre-assignment details

Follow-up ended on 7 January 2015. Participants were excluded for premorbid learning disabilities, concurrent illness/injury at pre-test and complicated or atypical symptom presentation per treating clinician (e.g. symptoms incongruent with cognitive load).

Participants by arm

ArmCount
Gaming
Members of this group will play SuperBetter in addition to receiving standard medical care for persistent concussion symptoms
20
Total20

Baseline characteristics

CharacteristicGaming
Age, Categorical
<=18 years
20 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
20 Participants
Number of participants with Sports Concussion Assessment Tool-3 (SCAT-3)Symptoms Score > 120 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
20 Participants
Race (NIH/OMB)
White
0 Participants
Region of Enrollment
United States
20 participants
Sex: Female, Male
Female
14 Participants
Sex: Female, Male
Male
6 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 20
other
Total, other adverse events
0 / 20
serious
Total, serious adverse events
0 / 20

Outcome results

Primary

Participation

Number of Participants who used the app and returned for post testing

Time frame: 8 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
GamingParticipation14 Participants
Secondary

Satisfaction With App

Satisfaction rating on a 7 point Likert scale ranging from 1 (very satisfied) to 7 (very dissatisfied) among those who used the app and returned for post testing

Time frame: 8 weeks

ArmMeasureValue (MEDIAN)
GamingSatisfaction With App2.0 units on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026