The blinding lies in not telling the test subject, the carers, or the clinician whether the test subject is on the active treatment or the sham. This prevents anybody's expectations influencing their judgement on whether or not they experience an improvement.
Before her tests are complete - 12 weeks - telling little Michelle, or her parents, or her clinician that she has the active device might influence the test results.
After Michelle's test is complete however, and all of Michelle's measurements have already been taken, what possible difference can it make to tell her whether she had the active device or the sham? None that I can see. Nobody's going to grab the lab book and rewrite the measurements.
And if we tell everybody in the world that Michelle had the active treatment, what possible difference can it make to George or his parents or his clinician even if George has only just started? None again that I can see. George and his team know what Michelle had, but it tells them nothing about what George has.
The blinding is only violated if information is revealed that can influence the results. I don't see that it has. And therefore it seems perfectly valid to continue to call the study a randomised double-blind prospective trial.
I'm wrong if you can identify any information that has been released that would reveal to participants who haven't yet completed their tests which arm of the trial they're on. Can you?
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