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Vision Blinding of Participants in Limb Prosthetic Research Is Unnecessary (JPO032-3B)
Journal of Prosthetics and Orthotics: Volume 32, Issue 3
Keyword(s)
JPO032-3B
Introduction: This research addresses a common limitation in prosthetic and orthotic research, where subject blinding, for example, concealment of the group assignment, is difficult to implement. The purpose of this study was to investigate how effectively people with limb prostheses can be blinded to a typical research intervention. It was hypothesized that vision blinding reduces the accuracy of patients' assessment of prosthesis alignment changes.
Methods: Users of a lower-limb prosthesis who were able to walk without aid were recruited as participants for this randomized crossover intervention study. Exclusion criteria were visual impairments and use of a prosthesis that disallows temporary alignment changes. Blinding (four levels) and prosthetic ankle alignment perturbation (five levels) were combined to result in a total of 20 randomized conditions per participant. Participants' accuracy and surety of assessing the alignment perturbation were evaluated as the main outcome measures.
Results: Correctness of alignment assessment with and without blinding was not found to be significantly different (P = 0.230). Subject's surety about their own assessments was significantly lower with vision blinding (P = 0.005).
Conclusions: Vision blinding did not seem to affect subjects' awareness of prosthetic interventions. (J Prosthet Orthot. 2020;32:175–181)
Methods: Users of a lower-limb prosthesis who were able to walk without aid were recruited as participants for this randomized crossover intervention study. Exclusion criteria were visual impairments and use of a prosthesis that disallows temporary alignment changes. Blinding (four levels) and prosthetic ankle alignment perturbation (five levels) were combined to result in a total of 20 randomized conditions per participant. Participants' accuracy and surety of assessing the alignment perturbation were evaluated as the main outcome measures.
Results: Correctness of alignment assessment with and without blinding was not found to be significantly different (P = 0.230). Subject's surety about their own assessments was significantly lower with vision blinding (P = 0.005).
Conclusions: Vision blinding did not seem to affect subjects' awareness of prosthetic interventions. (J Prosthet Orthot. 2020;32:175–181)
Credit Information
2.0 Credits (Scientific)
Author(s)
Anna Marie Clark, BS; Goeran Fiedler, PhD
Description
Principles of good research trial design include randomization, independent sampling, and control by a placebo group or arm. Blinding, for example, concealing the group assignment, is another way to add credibility to research because it eliminates biases. To avert the bias that may be introduced by preconceptions, it is recommended to blind trial participants, re-search investigators, and data analyzers to the interventions. The method quality of a study improves as more involved parties are blinded (e.g., a double-blinded protocol is preferable to a single-blinded protocol). In studies that have appropriate blinding, interventions effects tend to be smaller than in studies withoutproper blinding. Moreover, blinding increases the likelihood that the observed differences between groups stems from the intervention and not from bias. Blinding becomes especially important in studies that include subjective measurements which are more susceptible to bias than objective measurements.