NCT06971510

Exoskeleton Training on Balance Control and Turning in Ambulation in Individuals With Incomplete Spinal Cord Injury

The Effectiveness of Robotic Exoskeleton on Sensori-motor Performance in Subjects With Incomplete Spinal Cord Injury: A Functional Near-Infrared Spectroscopy Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Hong Kong Metropolitan University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study investigates the impact of exoskeleton training on individuals with incomplete spinal cord injury (iSCI). Investigators focus on assessing how the use of the exoskeleton influences balance control and turning during ambulation and quality of life in this population. The study mainly involves interventions with participants utilizing exoskeleton devices to explore the influence on mobility, stability, and neuroplasticity, providing new insights into the potential benefits of exoskeleton training for individuals with incomplete spinal cord injuries.

Detailed description

Spinal cord injury (SCI) poses profound challenges to individuals, disrupting complex neural pathways responsible for motor and sensory functions. Across a spectrum of impairments, the ability to navigate and maneuver during walking, particularly turning, is a significant obstacle for patients with incomplete SCI (iSCI). Despite advances in rehabilitation strategies, turning-while-walking remains a biomechanically demanding task that is often overlooked in traditional interventions that focus primarily on linear gait training. Turning-while-walking requires coordinated movements of the head, trunk, pelvis, and limbs. Disruption of sensory pathways and impairment of motor control after iSCI complicates this complex process, resulting in impaired balance, increased risk of falls, and decreased quality of life. While traditional rehabilitation methods strive to address these challenges, they often fail to target the specific complexities of turning dynamics. Robotic exoskeletons are wearable devices designed to enhance mobility for iSCI patients. These innovative technologies are expected to enhance sensorimotor performance by providing external support, promoting gait symmetry, and promoting neuroplasticity through intensive training. Exoskeleton-assisted therapy has the potential not only to restore physical function, but also to promote psychosocial well-being, allowing individuals to participate more fully in daily activities and social interactions. However, despite the growing body of research demonstrating the benefits of exoskeleton training, its efficacy in improving turning-while-walking performance among individuals with iSCI remains uncertain. Furthermore, the neurological mechanisms underlying the response to exoskeleton training in this population warrant deeper investigation. This study aims to elucidate the effectiveness of a robotic exoskeleton on sensorimotor performance in subjects with iSCI. By filling gaps in the existing literature through rigorous methodology and comprehensive evaluation, investigators strive to provide valuable insights into the potential of exoskeleton-assisted therapy to optimize rehabilitation outcomes and improve the lives of iSCI survivors. Through a multidimensional approach encompassing both physical and psychosocial domains, this research seeks to pave the way for more tailored and effective interventions in SCI rehabilitation, ultimately fostering greater independence and well-being for those affected by this debilitating condition. The objective of the cluster randomized controlled trial is to investigate the effectiveness of exoskeleton training specifically on turning-while-walking performance, balance control, gait function, muscle strength, spasticity, quality of life, self-efficacy, and fall incidence in people with iSCI. Moreover, the study will also explore how exoskeleton training may promote neuroplasticity and its relationship with ambulatory function and balance control changes in people with iSCI. The three centers will serve as distinct clusters and will be randomized into three groups: 1) Exoskeleton Training Group (ETG), 2) Conventional Exercise Group (CEG), and 3) Usual Care Control Group (UCG). The ETG and CTG will undergo 24 training sessions over 12 weeks respectively, and the UCG will receive standard care. Assessments will be conducted at baseline, midpoint (Week 6), post-intervention (Week 12), and one-month post-intervention to evaluate outcomes such as turning-while-walking performance, balance control, gait performance, muscle strength, spasticity, self-efficacy, fall incidence, and quality of life. Additionally, cortical activity will be measured to explore changes in neural pathways and their correlation with turning performance and balance control during ambulation.

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
DEVICE	Exoskeleton Training	Using EksoNR to train balance control and walking and turning abilities in patients with incomplete spinal cord injury.
OTHER	Conventional Physical Therapy	Using conventional physical therapy methods to train the balance control and walking and turning abilities in patients with incomplete spinal cord injury.

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-11-30
• Completion: 2025-11-30
• First posted: 2025-05-14
• Last updated: 2025-05-14

Locations

3 sites across 1 country: China