Experiences of participating in a regenerative randomized controlled trial following traumatic spinal cord injury: A longitudinal qualitative process evaluation

Context: There is a current knowledge gap regarding spinal cord injured patients’ motives and expectations when enrolled in regenerative studies. In addition, the impact of trial participation on daily life and perceived intervention effects remains undescribed.Objective: To describe the experiences of participating in a regenerative randomized controlled trial following traumatic spinal cord injury.Design: Longitudinal qualitative process evaluation.Setting: University hospital and rehabilitation center in Sweden.Participants: Nine participants with a complete chronic traumatic thoracic SCI, included in the SC0806 study.Interventions: Participants were in the SC0806 study allocated to one of two treatment arms: surgical implantation of a biodegradable device followed by robot-assisted gait training (RAGT), or RAGT alone.Outcome measures: Semi-structured interviews were performed four times: before randomization, at six months, 18, and 30 months after randomization. Audio-recorded interviews were transcribed and were analyzed with manifest content analysis, following a pattern-oriented longitudinal approach to inductively describe experiences over time.Results: In total, 32 interviews were conducted. Motives for participating were potential functional recovery and altruism. Surgical implantation resulted in physical symptoms that changed over time; for some participants, neurological pain and spasticity were reduced. The RAGT sessions and traveling were time-consuming and affected various aspects of everyday life. Participants completed the study according to the SC0806 protocol, despite the research burden.Conclusions: Study participation involved a substantial research burden; however, acceptability within the treatment arms, as well as sustainability and participant retention, were satisfactory. None of the participants who underwent surgical implantation experienced neurological deterioration.