An interventional study of Pressure Relief Monitoring System in Spinal Cord Injuries and Pressure Ulcer, sponsored by Rancho Research Institute, Inc.. Status unknown at 4 sites in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2018-06-13.
Sponsored by Rancho Research Institute, Inc. · Not applicable, Interventional, and Prevention
Among 968 studies in Spinal Cord Injuries with a site in United States — 250 open to participants now, 308 under way, 7 of them phase 3. Spinal Cord Injuries · United States.
Among the 968 studies in Spinal Cord Injuries with a site in United States, this one is the 83rd largest by planned enrollment of the 836 interventional ones that give a count, is one of 66 that started in 2018, is one of 601 with no phase, and was the 442nd registered.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
Browse Spinal Cord Injuries studies →250 of the 968 studies in Spinal Cord Injuries with a site in United States are open now. Recruiting first, the newest first:
Johns Hopkins University · Sites in United States
University of Miami · Sites in United States
Neuralink Corp · Sites in United States
Rahul Sachdeva · Sites in United States
Northwell Health · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 375 Spinal Cord Injuries studies recruiting now, 166 (44%) set no upper age limit and 158 (42%) stop at 75 or younger; 41 take children under 18; 52 take healthy volunteers.
This study: 18 Years to 100 Years · all sexes · no healthy volunteers.
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968 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 94 · Phase 2 132 · Phase 3 39 · Phase 4 27
First in 1986; this study’s year is marked. 66 started in 2018.
This study's planned enrollment of 100 is above the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Median enrollment 24 across the 836 interventional studies, 58 across the 128 observational. Of the 576 that completed or were terminated, 223 (39%) have results posted.
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75 of 968 have an industry lead sponsor. The 10 most frequent:
Rancho Research Institute, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Rancho Research Institute, Inc. has 3 studies filed under Spinal Cord Injuries — fewer than ten, so there is no comparison to draw.
120 of the studies in Spinal Cord Injuries with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05903859Phase 3University of MiamiImprovement of Reproductive Function in Men With Spinal Cord Injury (SCI) | 2027-05-31 |
| NCT07625332Phase 3Northwell HealthPilot Study of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI) | 2027-08 |
| NCT03930056Shirley Ryan AbilityLabC-Brace II Spinal Cord Injury | 2026-11 |
| NCT04077346University of LouisvilleNeuromodulation of Spinal Locomotor Circuitry to Elicit Stepping After Pediatric Spinal Cord Injury | 2026-11 |
| NCT05423600Virginia Commonwealth UniversityTransspinal Stimulation With and Without Blood Flow Restricted Exercise Via Telehealth in Persons With Tetraplegia | 2026-11 |
Among the 968 studies in Spinal Cord Injuries with a site in United States, from their registry updates:
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The goal of this module project is to establish the efficacy of a portable sensor and app-based biofeedback technology system for promoting effective pressure relief behaviors and reducing risk of pressure ulcer development among wheelchair users. In collaboration with the participating SCIMS centers, the investigators will conduct a randomized clinical trial of education and goal setting alone compared to education and goal setting combined with the biofeedback system (SENSIMAT®) that is commercially available.
Overview and Rationale:
Pressure ulcers (PUs) are a frequent and serious secondary complication after SCI with an annual incidence of 31% and a lifetime incidence of up to 85%. PUs are linked to increased morbidity and mortality. As medical or surgical repair of established PUs is difficult and costly, the preferred approach is prevention. Traditional prevention recommendations included intermittent relief of interface pressure, such as performing wheelchair (WC) pushups every 30 minutes for 30 seconds or once an hour for 60 seconds. Alternatives to the push-up maneuver, including forward and lateral trunk leans, have been recommended to reduce the demands of weight bearing on the shoulders. One approach to address inadequate PR is to provide a simple reminder (i.e., an alarm) at set intervals. However, this approach is inadequate because patients who attempt PR maneuvers often do not achieve an adequate magnitude or duration of PR for tissue unloading. In addition, compliance with PR performance can be negatively impacted by unanticipated life circumstances. A system to measure PR maneuvers in the home and community and provide reminders and feedback on frequency and success of individual attempts of this important preventative activity could reduce the incidence of PUs. In this collaborative project, the investigators will establish the efficacy of a sensor and feedback technology system for promoting effective pressure relief behaviors and reducing risk of pressure ulcer development among wheelchair users. The investigators will conduct a randomized clinical trial of education and goal setting alone compared to education and goal setting combined with the biofeedback system (sensor and smartphone app) that is developed and validated. The fully functional system is unobtrusive and simple. The system attaches to any WC (without modification) and generates automatic reminders via an app. Biofeedback, also delivered via the app, indicates in real time when a PR maneuver has been completed successfully. The display also tracks the user's daily PR activity as the participants works towards a daily goal.
Specific Aims:
Primary: Compare PR behavior (daily PR frequency and average duration of uninterrupted sitting) between participants who receive education and four weeks of biofeedback training with the monitoring system (intervention group) and those who receive education but no system feedback (control group). Secondary: Compare the incidence of ischial PU development at one year post-intervention between groups.
Hypotheses:
Proposed Outcomes:
To establish the efficacy of the wheelchair seat sensor and app-based biofeedback for establishing healthy self-management behaviors (pressure relief maneuvers) and reducing incidence of pressure ulcer development in individuals with recent SCI.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The control group will continue to have the WC sensor system for measurement only and will not receive biofeedback after receiving instructions on the importance of pressure relief (PR) maneuvers for skin care, as well as training regarding the three pressure relief maneuvers. Materials (including fact sheets, etc.) will be incorporated in the educational content of the project.
The intervention group will receive biofeedback via the smartphone app.
Device: Pressure Relief Monitoring System
Biofeedback provided to the intervention group via the smartphone app will include: Visual (e.g., phone notification bar) and auditory reminders if PR (pressure relief) is not performed as scheduled, Real-time feedback during performance of PR maneuvers to ensure adequate PR (e.g., the app will indicate if the duration of PR is sufficient), and Aggregate counts of daily PR activity.
Also known as: Sensimat
PR maneuvers per day
Number of pressure relief maneuvers per day
Time frame: 8 weeks
Sitting time
Duration of uninterrupted sitting time in minutes per day
Time frame: 8 weeks
Pressure Ulcer Occurence
Incidence of ischial pressure ulcer occurence after one year
Time frame: 1 year
Plan to share: Undecided — De-identified primary and secondary outcomes data will be shared with collaborators
No publications or documents are linked to this record.
Started May 2018 (actual). Primary completion is estimated for Oct 2020, 29 months after the start.
Of 790 non-industry interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 29 months is below that.
Counting every sponsor, half of 839 studies reached it within 36 months; a quarter within 17 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Rancho Research Institute, Inc.