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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Dec 16, 2024
Date Accepted: Mar 24, 2025

The final, peer-reviewed published version of this preprint can be found here:

Locomotive Syndrome Digital Therapeutics Provided via a Smartphone App: Protocol for a Single-Group Trial

Sonobe T, Matsumoto Y

Locomotive Syndrome Digital Therapeutics Provided via a Smartphone App: Protocol for a Single-Group Trial

JMIR Res Protoc 2025;14:e70163

DOI: 10.2196/70163

PMID: 40246298

PMCID: 12046266

Locomotive Syndrome Digital Therapeutics Provided via a Smartphone Application: Protocol for a Single-Group Trial

  • Tatsuru Sonobe; 
  • Yoshihiro Matsumoto

ABSTRACT

Background:

Background:

Locomotive syndrome (LS) is a condition in which muscle weakness and reduced motor function due to musculoskeletal disorders cause reduced mobility and physical function. In Japan, musculoskeletal disorders are the most frequent reason for requiring home support or nursing care, and the prevention and improvement of LS are thus being emphasized. However, it is difficult for the elderly to make a habit of exercise therapy, which is the mainstay of LS treatment. We investigated whether digital therapy could (i) lead to behavioral change in the elderly and (ii) prevent or improve LS in the elderly.

Objective:

Objective:

We sought to determine whether the use of digital therapeutics (DTx) are useful for the prevention and improvement of LS in the elderly, and we assessed the effects of DTx on the participants' exercise awareness and motor function.

Methods:

Participants and

Methods:

We conducted a multi-center, prospective, longitudinal, non-randomized, single-group study of Japanese adults aged ≥40 years who were eligible for locomotive syndrome checks (LSCs). Each participant underwent an 8-week locomotion training (LT) intervention, and their subjective and objective motor abilities and motor awareness were objectively assessed at the following timepoints: the baseline (before the start of the DTx), an interim evaluation (4 weeks after the start of the DTx), and a final evaluation (8 weeks after the start of the DTx). We evaluated the participants' objective motor function using the Timed Up & Go (TUG) test, and we compare the results using a three-way analysis of variance (ANOVA) with the TUG test at the three evaluation timepoints as the dependent variable. The results of the 25-Geriatric Locomotive Function Scale (GLFS-25), which is a subjective measure of motor function, and those of the Behavioral Regulation in Exercise Questionnaire-3 (BREQ-3), which assesses motor awareness, were also evaluated using ANOVA in the same way as the TUG test. The significance level was set as 0.05/3=0.0167 after Bonferroni correction.

Results:

Results:

As of December 2024, this study has enrolled 44 participants, and 25 participants have a complete data set for the proposed analysis. Study participation is ongoing until March 2025 at minimum.

Conclusions:

Conclusions:

The study cohort will be used as a basis for further observational and intervention studies. This research could lead to more efficient use of medical resources and a reduction in the financial and medical burdens on individuals and the economy, and it could support the prevention and improvement of LS and the establishment of exercise habits among the elderly. Clinical Trial: We registered the trial with the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR), trial no. UMIN#000053922 (Receipt# R000061550). Date of enrollment 22/3/2024.


 Citation

Please cite as:

Sonobe T, Matsumoto Y

Locomotive Syndrome Digital Therapeutics Provided via a Smartphone App: Protocol for a Single-Group Trial

JMIR Res Protoc 2025;14:e70163

DOI: 10.2196/70163

PMID: 40246298

PMCID: 12046266

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