Application of Wearable Biofeedback Device in Gait Assessment for Parkinson’s Disease Patients: A Case Series Study

Research Background

Patients with Parkinson’s Disease (PD) often exhibit abnormal gait patterns, severely affecting their independence and quality of life. Gait abnormalities primarily manifest as reduced stride length, increased step frequency, and decreased ground reaction forces during the stance and swing phases. These gait issues significantly increase the risk of falls and reduce the patients’ independence and quality of life.

In recent years, wearable biofeedback technology has become an important research direction to improve gait problems in Parkinson’s Disease patients. Wearable biofeedback devices can extract gait characteristics in real-time during gait activities and provide personalized feedback stimuli based on specific gait events, thereby enhancing patients’ awareness of their gait abnormalities. The wearable vibration and tactile bidirectional interface (Bidirectional Interface, BI) used in this study was developed based on this principle.

Research Source

The study was jointly conducted by Thomas Bowman, Andrea Pergolini, and colleagues from Fondazione Don Gnocchi (Milan and Florence) and Scuola Superiore Sant’Anna (Pisa) in Italy. The paper was published in the 2024 issue of the “Journal of NeuroEngineering and Rehabilitation.”

Research Process

Participants and Methods

The study used a case series research method, including 7 Parkinson’s Disease patients, aged 70.4±8.1 years, with Hoehn and Yahr (H&Y) scores of 2.7±0.3. These patients participated in pre-training assessment, three training sessions, and post-training assessment over five consecutive days. Each training session lasted 40 minutes to help them familiarize themselves with the BI device. The study utilized the 10-meter walk test (10MWT) and the 2-minute walk test (2MWT).

Research Procedure

1. Pre-Training Assessment (Pre-TRN): In the preparatory assessment phase, patients randomly performed gait tests under both no biofeedback (No-BF) and biofeedback (BF) conditions. Gait parameter data were collected using pressure-sensing insoles and a motion tracking system.
2. Training Phase: Each patient underwent three training sessions, each lasting 40 minutes. Training content included explaining the biofeedback principle, seated and standing gait training, and ground walking training.
3. Post-Training Assessment (Post-TRN): After the training, the 10MWT and 2MWT were conducted again to evaluate the training effect by comparing the changes in gait parameters before and after training.

Biofeedback Strategies

The BI device designed two biofeedback strategies:

1. Stance Phase Enhancement Strategy: Aimed to increase the vibration time from heel strike to the stance phase, thereby improving the foot rolling mechanism in gait.
2. Swing Phase Enhancement Strategy: Activated the vibration unit when the pressure center was located at the forefoot, continuing until the swing event, designed to promote the swing mechanism in gait.

Data Analysis Methods

The study used descriptive statistics and the two-tailed Wilcoxon signed-rank test (p < 0.05) to evaluate the differences in gait parameters under conditions with and without biofeedback.

Main Study Results

Gait Parameter Improvement

The study results showed:

1. Gait Speed and Stride Length:
   • After using the biofeedback device, gait speed significantly increased (from 0.72 m/s to 0.95 m/s, p=0.043), and stride length increased (from 0.87 m to 1.05 m, p=0.023).
2. 2MWT Walking Distance:
   • After using the biofeedback, the walking distance in the 2MWT also significantly increased (from 97.5 m to 118.5 m, p=0.028).
3. Double Support Phase Time:
   • The study also found a significant reduction in double support phase time (from 29.7% to 27.2%, p=0.018).

Immediate and Long-Term Effects of Biofeedback Strategy

The comparison of immediate effects and training effects revealed that the immediate effect was limited, whereas short-term training showed a more significant improvement in gait with biofeedback.

Usability and Safety

All study participants completed the study without adverse events. The SUS (System Usability Scale) scores showed that five subjects rated the system’s usability between 60 and 80.3, and two subjects scored above 80.3, indicating relatively high usability.

Research Conclusion

This study demonstrates that the BI device is feasible and safe for monitoring gait characteristics in Parkinson’s Disease patients and providing synchronous vibration feedback. Short-term training showed significant gait improvement, proving the potential of the device in clinical assessment and rehabilitation. Further randomized controlled trials are needed to verify its application effects and long-term benefits in home environments.

Research Value and Significance

This study provides preliminary support for using the BI device as a clinical assessment and rehabilitation tool in the future, offering a new treatment option for gait improvement in Parkinson’s Disease patients. Its potential application in home and real-world environments is particularly promising. In the future, remote data collection and analysis can help patients who find it difficult to frequently visit hospitals to conduct gait training and rehabilitation anytime, anywhere.