Facilitators and Barriers to Spinal Cord Injury Clinical Trial Participation: Multi-National Perspective of People Living with Spinal Cord Injury

Abstract

These are exciting times for the translation of promising interventions for spinal cord injury (SCI) into testing with clinical trials. These interventions include acute surgical decompression, neuroprotection, neural repair, cell replacement, activity-based rehabilitation, and medical devices, including devices requiring surgical implantation. By nature, clinical trials can have strict inclusion and exclusion criteria, which narrow down the pool of potential participants. Meeting enrollment numbers for properly powered trials is a daunting task. Therefore, it is important that trials are designed in a manner that facilitates participation. The purpose of this research study was to learn more about the factors that encourage or interfere with the decision to participate in clinical trials from the perspective of people living with SCI. A multi-national survey was conducted, primarily online, in which 802 participants with SCI ranked 32 factors as facilitators or barriers, using a Likert-type scale. There were 13 universal facilitators, five universal barriers, and three universally neutral factors. The number one facilitator was possible improvement in functionality and the number one barrier was possible decline in functionality--as may be expected. However, many unexpected facilitators and barriers were identified. There also were certain factors that were strong barriers or facilitators to certain sub-groups of people living with SCI. All of these factors should be taken into careful consideration when designing clinical trials so as to promote enrollment and enable adherence to different protocols.

Facilitators and Barriers to International Collaboration in Spinal Cord Injury: Results from a Survey of Clinicians and Researchers

“…The consumer survey included 802 participants; the number one facilitator for participating in clinical research was the possibility of improving functionality and the number one barrier was the possibility of a decline in functionality. 24 While these results may have been expected, the unexpected facilitators and barriers that emerged from the survey include the possibility to learn more about their general health/SCI and potential out-of-pocket expenses, respectively. 24 The main goal of performing these surveys was to determine how SCI consumers, researchers, and organizations can work together to best support, design and conduct international SCI clinical research collaborations.…”

Motor cortical activity changes during neuroprosthetic-controlled object interaction

“…The loss of arm and hand function therefore leads to a severe loss of independence. This sense of loss is reflected in studies of people with spinal cord injury who report that restoration of arm and hand function is a top priority 1 – 3 . For injuries like spinal cord injuries and amputation, assistive technology is required to replace the functions previously performed by the arm and hand.…”

Health promotion and cardiovascular risk reduction in people with spinal cord injury: physical activity, healthy diet and maintenance after discharge— protocol for a prospective national cohort study and a preintervention- postintervention study

“…Patient adherence to the intervention is described at discharge by the patient, who will document participation in targeted education elements using a checklist. However, a 2016 study found that the most important factor facilitating participation in clinical studies was the possibility of learning more about SCI and health, which is a clear potential in the intervention study 73. A review by Van Wyk et al emphasises that patient education is an important part of the interdisciplinary rehabilitation of people with SCI and recommend an individualised approach and the use of different settings in which the patient can receive the education 29…”