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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
Results First Posted : April 6, 2021
Last Update Posted : April 6, 2021
Sponsor:
Information provided by (Responsible Party):
Lise Worthen-Chaudhari, Ohio State University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Concussion
Mild Traumatic Brain Injury
Moderate Traumatic Brain Injury
Intervention Behavioral: SuperBetter play
Enrollment 20
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).
Arm/Group Title Gaming
Hide Arm/Group Description Members of this group will play SuperBetter in addition to standard medical care for persistent concussion symptoms
Period Title: Overall Study
Started [1] 20 [2]
Completed 20
Not Completed 0
[1]
Enroll up to 20 participants
[2]
20 enrolled
Arm/Group Title Gaming
Hide Arm/Group Description Members of this group will play SuperBetter in addition to receiving standard medical care for persistent concussion symptoms
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
20
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
14
  70.0%
Male
6
  30.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
0
   0.0%
Unknown or Not Reported
20
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
20
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
Number of participants with Sports Concussion Assessment Tool-3 (SCAT-3)Symptoms Score > 1   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
20
 100.0%
[1]
Measure Description: The SCAT-3 is patient-reported outcome measure. Participants rate the severity level at which they are experiencing 22-items, that represent specific concussion symptoms. Severity per item ranges from 0 (none) to 6 (severe) at time of ecological momentary assessment. Scores are summed such that 0 corresponds to no symptoms, while 132 corresponds to severe incidence of all 22 items (i.e., worst presentation imaginable). Inclusion criteria for enrollment = a score of greater than 1.
1.Primary Outcome
Title Participation
Hide Description Number of Participants who used the app and returned for post testing
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gaming
Hide Arm/Group Description:
Members of this group will play SuperBetter in addition to standard medical care for persistent concussion symptoms
Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
14
  70.0%
2.Secondary Outcome
Title Satisfaction With App
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gaming
Hide Arm/Group Description:
Members of this group will play SuperBetter in addition to standard medical care for persistent concussion symptoms
Overall Number of Participants Analyzed 14
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
2.0
(2.0 to 2.0)
Time Frame 5 months (8/13/14 - 1/7/15)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gaming
Hide Arm/Group Description Members of this group will play SuperBetter in addition to standard medical care for persistent concussion symptoms
All-Cause Mortality
Gaming
Affected / at Risk (%)
Total   0/20 (0.00%) 
Hide Serious Adverse Events
Gaming
Affected / at Risk (%)
Total   0/20 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Gaming
Affected / at Risk (%)
Total   0/20 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lise Worthen-Chaudhari
Organization: The Ohio State University
Phone: 614-304-1421
EMail: liseworthen@gmail.com
Layout table for additonal information
Responsible Party: Lise Worthen-Chaudhari, Ohio State University
ClinicalTrials.gov Identifier: NCT01398566    
Other Study ID Numbers: 2011H0077
First Submitted: July 19, 2011
First Posted: July 20, 2011
Results First Submitted: September 18, 2017
Results First Posted: April 6, 2021
Last Update Posted: April 6, 2021