Digital Rehabilitation Adherence Study: Preliminary Design Notes

Status

Design stage — not yet enrolling. We're publishing our early thinking here in the interest of transparency about work in progress, and to invite feedback before finalising the protocol.

The question we want to answer

Does app-guided, remotely-monitored rehabilitation actually improve adherence and functional outcomes compared with standard clinic-based hand therapy alone — or does the benefit mainly reflect that patients who adopt digital tools were already more engaged with their recovery to begin with? Distinguishing these two explanations is the central methodological challenge for this study.

Current design thinking

• Comparison groups: patients undergoing a comparable procedure (likely starting with post-tendon-repair rehabilitation, given how protocol-sensitive that recovery is) randomised or matched between app-guided remote monitoring plus standard therapy, versus standard therapy alone
• Primary outcome: objective adherence to the prescribed home exercise programme, measured directly rather than self-reported
• Secondary outcomes: functional recovery scores (see our article on standardising outcome measurement) and range-of-motion recovery at matched intervals between groups

Open design questions we're still working through

• Whether randomisation is practical and ethical here, given that patients with smartphone access and digital comfort may differ systematically from those without it — a matched cohort design may be more honest about this limitation than forced randomisation
• How to fairly measure "adherence" in the standard-care arm, where by definition there's no digital tracking — likely self-report with its known bias, acknowledged explicitly as a limitation
• Appropriate sample size given the expected effect size, which is genuinely uncertain given how limited existing evidence in this specific population still is

Why we're sharing this before finalising it

Publishing early-stage protocol thinking is unusual for a clinical practice site, but we think it's more honest than presenting only finished, polished results — and we're genuinely interested in feedback from colleagues who've designed similar studies, particularly on the matching-versus-randomisation question above.

Get involved

If you've designed or run a comparable study and are willing to share methodology lessons, or if you're a patient who might be interested in future participation once this opens, please reach out via the Contact page.