JMIR Publications

ABSTRACT

Background:

Lower limb amputation rates are increasing owing to aging and vascular diseases. However, no standardized rehabilitation protocol for regaining walking ability has been established. Conventional rehabilitation delays prosthetic gait training until 6–8 weeks post-amputation, prolonging recovery and increasing medical expenses.

Objective:

This study aims to evaluate the impact of neurorehabilitation using the hybrid assistive limb (HAL)® for Medical Use Lower Limb Type on gait acquisition, improvement in activities of daily living (ADL), and enhancement of quality of life (QOL) in lower limb amputees. The effectiveness of early HAL®-assisted gait training before and after amputation will be assessed.

Methods:

This single-arm trial will include 20 patients undergoing unilateral transfemoral or transtibial amputations. HAL®-assisted gait training will be performed five days per week (30 min per session) until postoperative week 8. The primary outcome is a 2-min walking distance, while secondary outcomes include muscle strength, balance, gait parameters, and ADL/QOL measures. Statistical analyses will be conducted using SPSS, comparing results obtained at the following time points: preoperative, post-intervention, and 6-month follow-up.

Results:

The planned sample size is 20 patients, calculated using JMP Ver. 12 based on an expected 1.5-fold improvement in 6-min walk distance (effect size 0.8, α=0.05, power=0.8). Analyses will use SPSS Ver. 15.0. The 2-min walk test (primary outcome) and secondary outcomes will be compared at baseline, post-intervention, and 6-month follow-up using one-way ANOVA or Kruskal–Wallis test, with p-values <.05 and 95% confidence intervals reported.

Conclusions:

This is the first study to apply HAL®-assisted neurorehabilitation to patients with lower-limb amputations. Early gait training may increase prosthetic gait acquisition rates, shorten rehabilitation and hospitalization periods, and reduce medical costs. If effective, this study may contribute to the development of a Japan-originated rehabilitation program and provide clinical evidence supporting broader HAL® implementation for patients with lower limb amputations. Clinical Trial: This trial was registered in the Japan Registry of Clinical Trials (jRCT) under the identifier jRCTs062200031. The trial has been approved by the Certified Review Board (CRB6180006).