12 / Clinical Evidence Summary Clinician-facing · Claim substantiation

Adherence and range-of-motion outcomes

One-page summary of a multi-site study of the Kinetrace R1 in post-arthroscopic knee rehabilitation, written for physiotherapists and rehabilitation clinicians.

DisclaimerKinetrace R1 is a fictional device created for this portfolio. Document numbers, revision history and all clinical figures in this summary are illustrative. No proprietary or client material is reproduced. The regulatory structure and document conventions are real.

Document: KIN-CES-0019
Revision: 01
Audience: Healthcare professional
Claims review: Cleared 2026-02-11
Source study: KIN-CS-2025-03

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About this documentOne-page summary written for physiotherapists and rehabilitation clinicians, condensing a fictional multi-site study. Every claim is qualified and attributed to the study that supports it.

Study design

Prospective, randomised, two-arm study at four rehabilitation centres. 184 adults following arthroscopic knee surgery were randomised to a 12-week home exercise programme delivered either on paper (control, n=91) or through the Kinetrace R1 with clinician review (intervention, n=93). Primary endpoint was programme adherence, defined as the proportion of prescribed sessions completed. Secondary endpoint was change in active knee flexion from baseline to week 12.

Results

Endpoint	Intervention	Control	Difference	p
Adherence, sessions completed	78.4%	61.2%	+17.2 pp	<0.001
Active knee flexion, change from baseline	+41.3°	+36.8°	+4.5°	0.04
Patients reporting device-related skin irritation	4 (4.3%)	—	—	—

What this supports, and what it does not

The adherence result supports a claim of improved programme adherence against a paper-based home programme in post-arthroscopic knee rehabilitation. It does not support a general claim of improved adherence, because the population was limited to one surgical indication and all patients received clinician review alongside the device.

The flexion difference reached statistical significance but falls below the 5° threshold the investigators pre-specified as clinically meaningful. It is reported as a secondary finding and is not used in product claims.

Claim wordingApproved: "improved adherence to home rehabilitation programmes compared with paper-based instruction in post-arthroscopic knee rehabilitation (Kim et al., 2025)." Not approved: "improves rehabilitation outcomes" — unsupported by the flexion result, and broader than the studied population.

Safety

Four patients reported mild skin irritation at the electrode site, all resolving within 48 hours without treatment. No serious adverse device effects were reported. Skin irritation is addressed in the instructions for use and is under post-market surveillance per the PMCF plan.

Standards applied

EU MDR Annex XIV Part A MEDDEV 2.7/1 rev 4 ISO 14155 PMCF plan KIN-PMCF-0021

Authoring notes

The section that earns this document its place is "what this supports, and what it does not". A clinical summary that reports only the favourable reading of a result is the thing a regulator finds and a competitor challenges. Stating the boundary of the claim in the same document that presents the data is what makes the approved wording defensible — and it gives the marketing team a line they can use without going back to the clinical file each time.