Trial Outcomes & Findings for Clinical Trial of a Rehabilitation Game - SuperBetter (NCT NCT01398566)

NCT ID: NCT01398566

Last Updated: 2021-04-06

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2021-04-06

Participant Flow

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.

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).

Participant milestones

Measure	Gaming Members of this group will play SuperBetter in addition to standard medical care for persistent concussion symptoms
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Trial of a Rehabilitation Game - SuperBetter

Baseline characteristics by cohort

Measure	Gaming n=20 Participants Members of this group will play SuperBetter in addition to receiving standard medical care for persistent concussion symptoms
Age, Categorical <=18 years	20 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	20 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants
Number of participants with Sports Concussion Assessment Tool-3 (SCAT-3)Symptoms Score > 1	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

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

Outcome measures

Measure	Gaming n=20 Participants Members of this group will play SuperBetter in addition to standard medical care for persistent concussion symptoms
Participation	14 Participants

SECONDARY outcome

Timeframe: 8 weeks

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

Outcome measures

Measure	Gaming n=14 Participants Members of this group will play SuperBetter in addition to standard medical care for persistent concussion symptoms
Satisfaction With App	2.0 units on a scale Interval 2.0 to 2.0

Adverse Events

Gaming

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lise Worthen-Chaudhari

The Ohio State University

Phone: 614-304-1421

Email: liseworthen@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place