Effects of a Soft Robotic Exoskeleton for Gait Training on Clinical Outcomes in Patients With Parkinson Disease: Randomized Controlled Pilot Study

Clinical Snapshot

Key Findings

• P Value: Primary outcomes P<0.001, between-group differences P=0.04-0.048

• Effect Size: Large effect sizes for gait parameters and moderate effects for clinical scales

• Primary Outcome: Bilateral stride length increased by mean 0.15m (95% CI 0.09-0.21m, P<0.001)

• Nnt Or Sensitivity: Not calculable from provided data - continuous outcomes reported as mean differences

• Confidence Interval: Narrow confidence intervals indicating good precision across outcomes

Clinical Application

Requires specialized robotic equipment and trained personnel. 20-minute sessions 5 times weekly appears feasible in rehabilitation settings Technology would need TGA approval for therapeutic use. Could integrate with existing NDIS-funded rehabilitation programs for PD patients. Aligns with RACGP recommendations for multidisciplinary PD management Adults with Parkinson disease experiencing gait and balance impairments suitable for rehabilitation

Abstract

BACKGROUND: Balance and gait disorders in Parkinson disease (PD) impair motor function and quality of life. OBJECTIVE: Evidence on soft exoskeleton robots (SERs) for PD rehabilitation is limited. This study evaluated the impact of SERs on motor dysfunction in PD. METHODS: A total of 56 people with PD (July 2023 to May 2024) were randomized to 2 groups: the control group (n=25, 44.6%) received conventional rehabilitation, and the experimental group (n=31, 55.4%) received conventional rehabilitation combined with SER training (ChiCTR2500111990). Training occurred 5 times per week for 20 minutes each session over 4 weeks. Primary outcomes included gait speed and stride length, while secondary outcomes assessed the percentage of swing phase, ankle joint range of motion, Unified Parkinson Disease Rating Scale total and motor scores, and Montreal Cognitive Assessment. Paired sample t tests (2-tailed) were used for within-group pre- and postintervention comparisons, and independent sample t tests (2-tailed) were used for between-group comparisons. Correlation analyses were conducted between gait parameters and improvements in ankle mobility. RESULTS: After 4 weeks, the experimental group showed significant improvements in gait and balance. Specifically, left stride length increased by a mean of 0.15 (SD 0.16; 95% CI 0.09-0.21) m (P<.001), right stride length by a mean of 0.15 (SD 0.15; 95% CI 0.10-0.21) m (P<.001), left ankle dorsiflexion by a mean of 2.84 (SD 1.46; 95% CI 2.32-3.36) degrees (P<.001), left swing phase percentage by a mean of 1.56% (SD 3.05%; 95% CI 0.44-2.68; P=.01), and right swing phase percentage by a mean of 1.6% (SD 2.72%; 95% CI 0.62-2.62; P=.002). The Unified Parkinson Disease Rating Scale Part III total score decreased by a mean of 2.80 (SD 3.98) points, and balance subscale scores decreased by a mean of 0.40 (0.58) points (P<.001). Montreal Cognitive Assessment scores increased by a mean of 1.23 (1.23; 95% CI 0.77-1.68) points (P<.01), and Barthel Index scores increased by a mean of 6.84 (7.14; 95% CI 4.22-9.46) points (P<.001). Other measures such as balance reaction time, reaction speed, maximum movement distance, and movement direction control showed significant improvement (P<.01). Compared to the control group, the experimental group demonstrated greater improvements in gait speed (P=.04), balance reaction time (P=.04), and maximum movement distance (P=.048). Correlation analysis revealed that improvements in left ankle dorsiflexion were positively correlated with improvements in gait speed, stride length, and swing phase duration (P<.05). CONCLUSIONS: SER-assisted training significantly improves gait, balance, and PD symptoms. Our work integrates multidimensional assessments (gait analysis, balance metrics, and clinical scales) and reveals that gains in ankle mobility directly correlate with gait improvements, suggesting a key mechanism. This study contributes by establishing SER as an effective adjunct to conventional therapy, supported by comprehensive quantitative data.

References

1. 1.Bu, S., Luo, X., Li, S., Shi, Y., Jin, L., & Zhao, Q. (2026). Effects of a Soft Robotic Exoskeleton for Gait Training on Clinical Outcomes in Patients With Parkinson Disease: Randomized Controlled Pilot Study. Journal of Medical Internet Research. https://doi.org/10.1109/TNSRE.2016.2551642