Ugolini Alessandro [Independent Researcher, Empoli (FI), Italy]
Verola Sofia [Unit of Functional Rehabilitation, Department of Allied Health Professions, Azienda USL Toscana Centro, Florence, Italy]
Pellicciari Leonardo [IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy]
Di Bari Mauro [Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy; Department of Medicine and Geriatrics, Unit of Geriatrics, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy]
Paci Matteo [Department of Allied Health Professions, Azienda USL Toscana Centro, Florence, Italy; Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy]
Recent randomized clinical trials (RCTs) provide statistical evidence on the effects of robot-assisted training (RAT) for upper limb impairments in post-stroke subjects; however, evidence on RAT clinical relevance is lacking. RCT findings are commonly judged in terms of their statistical significance, i.e. trying to ascertain whether the difference between the experimental and control groups evaluated is real and not attributable to chance. However, from a clinician’s perspective it is important that the RCT results are clinically relevant, i.e. that the effect size of the change is large enough to indicate that the patient’s condition has clinically improved. Usually, the clinical relevance is expressed by the minimal clinical important difference (MCID), i.e., the smallest change that is significant to the patient. Therefore, this study aimed to perform a systematic review with meta-analyses on the clinical relevance, expressed by the MCID, of RAT in improving independence in the activities of daily living, arm function and impairments in patients with stroke.
Four databases were queried until February 2023. RCTs investigating the RAT aimed to recover motor and functional skills of the upper limb in adult post-stroke patients were included. MCID values for each assessment tool were retrieved from specific databases. Two reviewers independently performed the screening, the data extraction and the assessment of methodological quality. Seven domains of the outcome measures were considered: activities of daily living, arm function, muscle strength, dexterity, muscle tone and pain. Two different sets of meta-analyses were performed, one for statistical significance and one for clinical relevance. When an MCID value was available, the clinical relevance of the original findings was expressed as standardized MCID overall score (SMOS), calculated as the difference between the mean of the outcome measures in the experimental and control groups divided by the corresponding MCID. The 95% CI associated with the SMOS point estimate was calculated using a pooled SD normalized by the corresponding MCID.
Eighty-five studies were included in this systematic review and meta-analysis. In terms of statistical significance, meta-analyses showed that the domains of activity limitations (SMD=0.29; 95% CI: 0.15; 0.43), dexterity (SMD=0.19; 95% CI: 0.01; 0.37), function (SMD=0.28; 95% CI: 0.17; 0.39) and strength (SMD=0.44; 95% CI: 0.17; 0.71) showed a significant effect in favor of the experimental group; moreover, the domain of pain (SMD=0.53;95% CI:-0.15; 1.20) showed a non-significant effect in favor of the experimental treatment, while the domains of muscle tone (SMD=-0.02; 95% CI:-0.26; 0.23) showed a non-significant effect for the control group. However, none of the outcomes showed clinically relevant findings in the meta-analyses of the SMOSs, which was always <1.00, indicating that the advantage observed in the experimental group was lower than the corresponding MCID.
The findings of this systematic review with meta-analysis showed that the RAT produces significant improvements in activity limitations, dexterity, function and strength but not in muscle tone and pain in patients with stroke when compared to control groups, but these improvements are not clinically relevant. Using the RAT in clinical practice can produce little improvement that cannot be relevant for stroke patients. Future research in this field should consider the clinical relevance when interpreting RCT results.
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