Spinal Cord Injuries Clinical Trial
Official title:
Interactive Telehealth and Auto-Biofeedback Sensor System for Individuals Who Use a Wheelchair: Phase II
During typical daily activity, people with established spinal cord injury perform significantly fewer pressure-relief maneuvers than the recommended frequency while overestimating their adherence on recall surveys of pressure relief activity. The rate of pressure ulcer recurrence in individuals with a prior ulcer is 44% in those with surgical repair and as high as 75% in those with non-surgical healing indicating that increased attention to pressure relief is critical for these individuals.This study will evaluate the efficacy of a wheelchair sensor and app-based biofeedback for establishing healthy self-management behaviors (pressure relief maneuvers and daily physical activity). Investigators will enroll 50 participants with paraplegia from spinal cord injury who use a manual wheelchair for mobility and have a history of pressure ulcer that has healed or is six months post-surgical repair. Participants will be randomized into one of two groups: an intervention group that will receive an education intervention and the proposed technology to be used for one year, and a control group that will receive only the education intervention. The primary outcome will be pressure ulcer occurrence over one year. Investigators hypothesize that participants receiving the intervention of biofeedback on their pressure relief activity will have a lower recurrence of pressure ulcer than the education only control group. Secondary outcomes include depressive symptoms, self-efficacy, participation and satisfaction with life. Investigators hypothesize that increasing physical activity will reduce depressive symptoms and improve participation and satisfaction with life.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | January 2022 |
Est. primary completion date | April 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - paraplegia from Spinal Cord Injury - a history of pressure ulcer that has healed or 6 months post surgical repair - use a manual wheelchair for mobility - able to perform pressure relief maneuvers independently Exclusion Criteria: - unable/unwilling to return to clinic for follow-up visits |
Country | Name | City | State |
---|---|---|---|
United States | Rancho Los Amigos National Rehabilitaiton Center | Downey | California |
Lead Sponsor | Collaborator |
---|---|
Rancho Research Institute, Inc. | BioSensics, National Institute on Aging (NIA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrence of Pressure Ulcer | Any stage of Pressure Ulcer/Injury identified in the ischial region | Any time during the one year active phase of the study intervention | |
Primary | Change in mean number of cycles of self-propulsion per day from Baseline | The increase or decrease in number of cycles of self-propulsion per day over the 4 weeks preceding the 12 month assessment | The four weeks preceding the 12 month assessments | |
Primary | Change in mean number of pressure relief maneuvers per day from Baseline | The increase or decrease in mean number of pressure relief maneuvers per day over the 4 weeks preceding the 12 month assessment from Baseline | The four weeks preceding the 12 month assessments | |
Primary | Time to Recurrence of Pressure Ulcer | The number of days from study entry to identification of recurrence of Pressure Ulcer/Injury | Any time during the one year active phase of the study intervention | |
Secondary | Change in Patient Health Questionnaire-9 score | Change in Questionnaire scores measuring depressive symptoms at 12 month assessment from baseline score | 12 months | |
Secondary | Change in University of Washington Self Efficacy Short Form | Change in scores on Questionnaire measuring self-efficacy at 12 month assessment from baseline score | 12 months | |
Secondary | Change in Reintegration to Normal Living Index | Change score on Questionnaire measuring participation at 12 month assessment from baseline score | 12 months | |
Secondary | Change in Satisfaction with Life Scale | Change in score on Questionnaire measuring satisfaction with life at 12 month assessment from baseline score | 12 months |
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