Effect of gait training using rhythmic auditory stimulation on gait speed in older adults admitted to convalescent rehabilitation wards: A study protocol for a pilot randomized controlled clinical trial.

Background: Decreased walking speed in older patients admitted to convalescent rehabilitation wards (CRWs) is one of the factors that inhibit home discharge. Therefore, interventions to improve gait speed in older patients admitted to CRWs are important, and rhythmic auditory stimulation (RAS) may be an effective intervention strategy. However, the effect of RAS on gait speed in older patients admitted to CRWs is not well known. Therefore, this study protocol aims to determine the feasibility of the RAS-based gait practice for older patients admitted to the CRW. Methods: The study is designed as a single-center, open-label, pilot, randomized, parallel-group study. Participants will be 30 patients aged ≥65 years admitted to the CRW and randomly assigned to the experimental group (RAS-based gait practice; n = 15) or the control group (normal gait practice; n = 15). In both groups, interventions will be conducted for 30 min per session, 5 times per week for 3 weeks. The primary outcome is the change in the 10-m walk test 3 weeks after the baseline assessment. Secondary outcome is the change in the score of the Medical Outcome Study 8-Item Short-Form Health Survey and the Japanese version of the modified Gait Efficacy Scale from baseline assessment to 3 weeks later. Discussion: This exploratory RCT was developed using strict scientific standards and is based on defined protocols. Thus, this study will be used to assess the viability of a larger investigation into RAS-based gait practice. If our theory is accurate, this study could serve as a foundation for establishing RAS-based gait practice in CRWs as a common rehabilitation strategy. Trial registration: This study was registered in the University Hospital Medical Information Network (UMIN) clinical trials registry in Japan (UMIN000049089).