Cost-Effective Clinical Methods to Evaluate the Efficacy of Gait Training Devices: A Systematic Review of Randomized Controlled Trials

Abstract

This systematic review was aimed at identifying cost-effective outcome assessment metrics to perform clinical trials for assessing the efficacy of novel, low-cost gait training devices. The search was conducted by the investigators through electronic databases, namely, SCOPUS (91), Web of Science (93), PubMed (141), and Cochrane Library (164), from origination to Mar. 31, 2024. The study design was a preferred reporting items for systematic reviews and meta-analyses (PRISMA) style systematic review of randomized controlled trials (RCTs) of robotic gait training devices (RGTDs) that treated stroke patients. Based on our inclusion and exclusion criteria, 17 randomized controlled trials were studied to identify suitable outcome assessment measures. This involved 705 patients at different stages of stroke, who were treated with different intervention durations, devices, randomization, and blinding methods. It was observed from the extensive clinical trials with the RGTDs that it was tested with a variety of assessment methods. Cost-effective outcome assessment measures that require commonly available materials are chosen and discussed in this review. It is identified that the most extensively used measures possess concurrent validity, sufficient inter-rater, intra-rater, and test-retest reliability. Clinical trials with a sophisticated setup cannot be afforded by clinics in low-income countries. It is vital to identify assessment methods that require commonly available materials that do not incur huge material costs. The methods discussed in this review can be administered without special training. This can facilitate quantifying and comparing the efficacy of these devices through clinical trials and multicentric investigations.