ABSTRACT
Background
People with severe brain injuries (PSBI) and reduced capacity to consent (CTC) frequently develop muscle contractures. Standard care includes prolonged stretch (PS) but there is limited condition-specific evidence from randomized controlled trials (RCTs).
Purpose
Identify factors affecting the inclusion of PSBI and reduced CTC in a PS RCT and methodologies more capable of generating condition-specific outcomes.
Methods
Mixed-method feasibility studies, including a pilot RCT (PSBI, adults with reduced CTC) comparing PS treatments (serial casting and splinting) and focus groups/interviews with physiotherapists involved in PS treatment. Reflexive thematic analysis developed themes.
Results
Two PSBI were included in the pilot RCT with no significant safety concerns or adverse effects. Twelve physiotherapists participated in two focus groups and two interviews. Four themes were identified: 1) complexity of contracture management; 2) burden of decision making; 3) lack of evidence and uncertainty; and 4) challenges to RCT acceptability and feasibility.
Conclusions
Reduced CTC contributes to the exclusion of PSBI from experimental research, and a circular paradox where poor research inclusion contributes to generalized healthcare and “evidence-biased medicine.” Due to the complexity of their condition, simply including PSBI in randomized research is unlikely to create meaningful health outcomes. Improving their care requires a paradigm shift toward pluralistic methods of knowledge generation.
Acknowledgments
The authors acknowledge and thank Luke Rendell for his contribution as the physiotherapist external to the research who provided the PS interventions and assisted with data collection, and Dr Sophie Duport for her support and guidance throughout the project.
Disclosure statement
No potential conflict of interest was reported by the author(s).