NCT02341950

Clinical Trial of a Serious Game for Individuals With SCI/D

Completed NA Last updated 22 February 2019

What this trial tests

NA trial testing SCI Hard in Spinal Cord Injury in 184 participants. Completed in 1 September 2017.

Timeline

5 February 2015

Primary endpoint
1 September 2017

1 September 2017

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	184
Start date	5 February 2015
Primary completion	1 September 2017
Estimated completion	1 September 2017
Sites	1 location across United States

Drugs / interventions tested

• SCI Hard

Conditions studied

• Spinal Cord Injury — all drugs for Spinal Cord Injury →
• Spinal Cord Involvement — all drugs for Spinal Cord Involvement →
• Spina Bifida — all drugs for Spina Bifida →
• Transverse Myelitis — all drugs for Transverse Myelitis →

Sponsor

University of Michigan

Who can join

Adults 13 to 29, any sex, with Spinal Cord Injury or Spinal Cord Involvement. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will evaluate the efficacy of a newly developed serious game, SCI HARD, to enhance self-management skills, self-reported health behaviors, and quality of life among adolescents and young adults with spinal cord injury and disease (SCI/D). SCI HARD was designed by the project PI, Dr. Meade, in collaboration with the UM3D (University of Michigan three dimensional) Lab between 2010 and 2013 with funding from a NIDRR (National Institute on Disability and Rehabilitation Research) Field Initiated Development Grant to assist persons with SCI develop and apply the necessary skills to keep their bodies healthy while managing the many aspects of SCI care. The study makes a unique contribution to rehabilitation by emphasizing the concepts of personal responsibility and control over one's health and life as a whole. By selecting an innovative approach for program implementation, we also attempt to address the high cost of care delivery and lack of health care access to underserved populations with SCI/D living across the United States (US).

H1: SCI Hard participants will show greater improvements in problem solving skills, healthy attitudes about disability, and SCI Self-efficacy than will control group members; these improvements will be sustained over time within and between groups.

H2: SCI Hard participants will endorse more positive health behaviors than control group members; these improvements will be sustained over time within and between groups.

H3: SCI Hard participants will have higher levels of QOL than control group members; these differences will be sustained over time within and between groups.

H4: Among SCI Hard participants, dosage of game play will be related to degree of change in self-management skills, health behaviors and QOL.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Beyond the Randomized Controlled Trial: A Review of Alternatives in mHealth Clinical Trial Methods.
   Pham Q, Wiljer D, Cafazzo JA. · · 2016 · cited 113× · PMID 27613084 · DOI 10.2196/mhealth.5720
2. The disparity in pediatric spinal cord tumor clinical trials: A scoping review of registered clinical trials from 1989 to 2023.
   Villanueva OP, Papadakis JE, Mosher AM, Cooney T, et al · · 2024 · PMID 39279782 · DOI 10.1093/nop/npae041