Digitally Assisted Versus Conventional Home-Based Rehabilitation After Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial.
Fernando Dias Correia, Maria Molinos, Sara Luís and 7 others
PMID 33935152WHAT IT FOUND
Digital home rehab with motion trackers and 13 therapist visits matched conventional rehab with 30 visits on shoulder function at 12 weeks.
Both groups improved clinically, but no significant difference was found. The study stopped early due to the pandemic, leaving it underpowered.
Key findings
01The primary outcome, change in Constant-Murley score from baseline to 12 weeks, showed no statistically significant difference between the digital and conventional groups.
02Patients in the digital group attended a median of 13 face-to-face sessions, compared with a median of 27 sessions for the conventional group.
03Recruitment was halted early due to the pandemic, resulting in a sample size below the planned 68 patients.
STILL TO COME
How it was doneWhat they foundWhat it means for PTsWhat it means for OTsWhat it means for SLPs
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What it does not show
The study was stopped early due to the COVID-19 pandemic, resulting in a sample size of 41 analyzed patients, which is below the planned 68. This leaves the study underpowered to detect small but potentially important differences. The nature of the intervention meant patients could not be blinded to their treatment group, which may influence self-reported outcomes. Home exercise time for the conventional group was not monitored, so the true difference in total treatment intensity between groups is unknown. The sample was predominantly female (78%), which may limit generalizability to male patients, particularly regarding attitudes toward technology use.
Declared interests
Several authors are employees of SWORD Health, the company that developed the digital therapeutic used in the study. One author is the Chief Medical Officer and owns stock, and others received honoraria from the company.
The easy way to misread this
Do not interpret the lack of significant difference at 12 weeks as proof that digital therapy is equally effective in all contexts. The study was underpowered due to early termination, and the authors' claim of non-inferiority relies on confidence intervals that are wide and may not exclude clinically meaningful differences.