JMIR Publications

ABSTRACT

Background:

Balance and gait disorders are major symptoms affecting the motor function and quality of life in patients with Parkinson's disease (PD). The use of exoskeleton robots in PD rehabilitation has been increasingly applied and is gradually recommended in both domestic and international guidelines. The new wearable soft exoskeleton robot (SER) offers advantages such as being lightweight, flexible, and easy to operate, expanding the application of robotic rehabilitation.

Objective:

However, there is currently insufficient evidence regarding its efficacy in assisting PD rehabilitation training. Therefore, this study aims to explore the effect of SER on improving motor dysfunction in PD patients.

Methods:

A total of 56 PD patients who met the MDS 2015 diagnostic criteria, admitted to our hospital from July 2023 to May 2024, were selected for the study. Patients were randomly assigned into two groups using a prospective, randomized, controlled method. The control group (n=25) received conventional rehabilitation training, while the experimental group (n=31) received conventional rehabilitation combined with SER training. Training was conducted five times per week, with each session lasting 20 minutes, for a duration of four weeks. Three-dimensional gait analysis was used to collect gait parameters, and balance instruments were used to measure balance function indicators. Primary outcomes included gait speed and stride length, while secondary outcomes included the percentage of swing phase in the gait cycle, ankle joint range of motion, balance reaction time, reaction speed, maximum movement distance, direction control, total Unified Parkinson's Disease Rating Scale (UPDRS) score, and its motor score (part III), cognitive function score (MoCA), and activities of daily living (Barthel Index, BMI). Paired sample t-tests were used for within-group pre- and post-intervention comparisons, and independent sample t-tests were used for between-group post-intervention comparisons. Spearman or Pearson correlation analyses were performed between gait parameters and improvements in ankle joint mobility.

Results:

There were no differences in baseline data between the two groups before training. After 4 weeks of training, the experimental group showed significant improvements in gait parameters, including an increase in left stride length by 0.15±0.16 meters (P=0.00), right stride length by 0.15±0.15 meters (P=0.00), left ankle dorsiflexion by 2.84±1.46 degrees (P<0.001), left swing phase percentage by 1.56±3.05% (P=0.01), and right swing phase percentage by 1.62±2.72% (P=0.002). The UPDRS-III total score decreased by 2.80±3.98 points, and the balance subscale score decreased by 0.40±0.58 points (P=0.00). MoCA scores increased by 1.23±1.23 points (P<0.01), and Barthel Index scores increased significantly by 6.84±7.14 points (P<0.001). Balance reaction time, reaction speed, maximum movement distance, and movement direction control all showed significant improvement (P<0.01). Compared with the control group, the experimental group showed a significantly greater improvement in gait speed (P=0.036), balance reaction time, and maximum movement distance (P=0.039, 0.048). Correlation analysis found that improvements in left ankle dorsiflexion were significantly positively correlated with improvements in gait speed, stride length, and swing phase duration (P<0.05). Improvements in left ankle plantarflexion were positively correlated with stride length (P<0.05), and improvements in left ankle plantarflexion and right ankle dorsiflexion were negatively correlated with increases in UPDRS-III balance subscale scores (P<0.05).

Conclusions:

SER-assisted walking training significantly improves gait abnormalities in PD patients, increases gait speed, and has a marked positive impact on balance, cognitive function, and activities of daily living. It represents a new and effective approach in PD rehabilitation training. Clinical Trial: This study has been approved by the Ethics Review Committee of Shanghai Yangzhi Rehabilitation Hospital (IIT-2024-019)