Clinical trial · Interventional
Clinical Trial of a Serious Game for Individuals With SCI/D
Evaluating the Effectiveness of a Serious Game to Enhance Self-Management Skills Among Adolescents and Young Adults With Spinal Cord Dysfunction
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polio and Post-polio Syndrome | — | UNRESOLVED | — |
| Spina Bifida | — | UNRESOLVED | — |
| Spinal Cord Diseases | — | UNRESOLVED | — |
| Spinal Cord Injury | — | UNRESOLVED | — |
| Spinal Cord Involvement | — | UNRESOLVED | — |
| Spinal Neoplasms | Spinal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Spinal Stenosis | — | UNRESOLVED | — |
| Syringomyelia | — | UNRESOLVED | — |
| Transverse Myelitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SCI Hard | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SCI Hard
- description
- This arm plays the SCI HARD game
- interventionNames
- Behavioral: SCI Hard
- type
- NO_INTERVENTION
- label
- Control
- description
- Plays an alternate, publicly available game
Primary outcomes (3)
- measure
- Change in scores on the Appraisals of Disability: Primary and Secondary Scale (ADAPSS) (used to assess change over time)
- timeFrame
- change scores at 1 months and 3 months (baseline to 1 month; baseline to 3 months; 1 month to 3 months)
- description
- Used to assess change over time in six dimensions of appraisal: fearful despondency, overwhelming disbelief, determined resolve, growth and resilience, negative perceptions of disability, and personal agency.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 13 Years
- Maximum age
- 29 Years
Show eligibility criteria text
Inclusion Criteria: * between the ages of 13 and 29 * have a spinal cord dysfunction * have access to a mobile device on which they can download and play the game * be English-speaking. Exclusion Criteria: * high degrees of emotional distress, suicidal intent, or anxiety (as determined by the Patient Health Questionnaire-Depression Module (PHQ-9) and Generalized Anxiety Disorder-7(GAD-7)). Individuals will also be required to answer questions to confirm that they understand the study as part of the informed consent process.
References
Publications (0)
Data not yet available