Feasibility randomised controlled trial comparing TRAK-ACL digital rehabilitation intervention plus treatment as usual versus treatment as usual for patients following anterior cruciate ligament reconstruction

Abstract

Objectives To evaluate the feasibility of trialling taxonomy for the rehabilitation of knee conditions—ACL (TRAK-ACL), a digital health intervention that provides health information, personalised exercise plans and remote clinical support combined with treatment as usual (TAU), for people following ACL reconstruction.Methods The study design was a two-arm parallel randomised controlled trial (RCT). Eligible participants were English-speaking adults who had undergone ACL reconstruction within the last 12 weeks, had access to the internet and could provide informed consent. Recruitment took place at three sites in the UK. TRAK-ACL intervention was an interactive website informed by behaviour change technique combined with TAU. The comparator was TAU. Outcomes were: recruitment and retention; completeness of outcome measures at follow-up; fidelity of intervention delivery and engagement with the intervention. Individuals were randomised using a computer-generated random number sequence. Blinded assessors allocated groups and collected outcome measures.Results Fifty-nine people were assessed for eligibility at two of the participating sites, and 51 were randomised; 26 were allocated to TRAK-ACL and 25 to TAU. Follow-up data were collected on 44 and 40 participants at 3 and 6 months, respectively. All outcome measures were completed fully at 6 months except the Client Service Receipt Inventory. Two patients in each arm did not receive the treatment they were randomised to. Engagement with TRAK-ACL intervention was a median of 5 logins (IQR 3–13 logins), over 18 weeks (SD 12.2 weeks).Conclusion TRAK-ACL would be suitable for evaluation of effectiveness in a fully powered RCT.