Exoskeletal-assisted walking combined with transcutaneous spinal cord stimulation to improve bone health in persons with spinal cord injury: study protocol for a prospective randomised controlled trial

BMJ Open, 2024 · DOI: 10.1136/bmjopen-2024-086062 · Published: March 4, 2024

Spinal Cord Injury Rehabilitation Musculoskeletal Medicine

Simple Explanation

This research protocol aims to compare the effectiveness of exoskeletal-assisted walking (EAW) alone versus EAW combined with transcutaneous spinal cord stimulation (EAW+tSCS) on improving bone density, geometry, and strength in individuals with chronic spinal cord injury (SCI). The study involves sixteen participants who will be randomly assigned to either the EAW alone group or the EAW+tSCS group, each receiving 108 overground training sessions over a 9-month period. Bone density and geometry will be assessed using dual-energy X-ray absorptiometry and peripheral quantitative CT at baseline, after 72 training sessions, and after 108 sessions to evaluate the impact of each intervention.

Study Duration

9 Months

Participants

16 chronic SCI participants

Evidence Level

Level 1, prospective randomised controlled trial

Key Findings

1
The combination of EAW+tSCS may promote a more reciprocal firing pattern for the flexors and extensors than EAW alone resulting in increased functional joint torque contribution of the lower limb.
2
This improved muscle activation pattern from tSCS could result in more normal mechanical forces on the lower extremity skeleton, greater ability to weight bear and ambulate, and a more appropriate stepping muscle activity as determined by electromyography.
3
The use of peripheral quantitative CT and CT-derived finite element model bone outcomes in this study may also improve the likelihood of detecting small changes in bone mineral density over time if an effect from either intervention arm exists.

Research Summary

This study protocol outlines a randomized controlled trial to investigate the effects of exoskeletal-assisted walking (EAW) alone versus EAW combined with transcutaneous spinal cord stimulation (tSCS) on bone health in individuals with chronic spinal cord injury (SCI). The primary aims are to compare the impact of these interventions on bone mineral content, volumetric bone mineral density, and bone strength at various sites in the lower extremities. The study employs advanced imaging techniques and finite element modeling to comprehensively assess changes in bone density, geometry, and strength, providing a detailed evaluation of the potential benefits of these interventions for individuals with SCI.

Practical Implications

Rehabilitation Strategies

The study's findings could inform rehabilitation professionals about effective interventions to combat sublesional osteoporosis in individuals with chronic SCI.

Improved Quality of Life

Restoration of sublesional bone could reduce fracture-related morbidity and improve the ability to participate in activity-based rehabilitation strategies, enhancing the quality of life for individuals with SCI.

Neuroregenerative Strategies

Improving sublesional bone health may reduce the risk of fragility fractures when weight-bearing activities or walking are incorporated into future neuroregenerative strategies.

Study Limitations

1
The electrode stimulation configuration to optimise motor neuron pool excitement and maximise limb movement may not be understood and implemented in this study.
2
Correct identification of the vertebral body level by palpating the spinous process for electrode placement is limited due to soft tissue obstruction, hardware placement and fusion from surgery, as well as interparticipant differences in the number of thoracic and lumbar vertebrates.
3
Finally, the investigators do not have a plan in place to perform a cost-effective analysis, making it difficult to understand the external generalisability of our findings.

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