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. 2024 Oct 18;25(1):690.
doi: 10.1186/s13063-024-08503-0.

Dosing overground robotic gait training after spinal cord injury: a randomized clinical trial protocol

Alexandria Suhalka  1 , Fernando Zanela da Silva Areas  1   2   3 , Faith Meza  1 , Christa Ochoa  1 , Simon Driver  1 , Seema Sikka  2 , Rita Hamilton  2 , Hui-Ting Goh  4 , Librada Callender  1   2 , Monica Bennett  1 , Hui-Ting Shih  1 , Chad Swank  5   6
Affiliations

Dosing overground robotic gait training after spinal cord injury: a randomized clinical trial protocol

Alexandria Suhalka et al. Trials. .

Abstract

Background: Robotic exoskeletons have changed rehabilitation care available to people after spinal cord injury (SCI). Yet, the current evidence base is insufficient to identify the optimal dose and neurophysiological mechanism of robotic exoskeleton gait training (RGT) as an effective rehabilitation approach. This study will (1) examine whether the frequency of RGT after motor incomplete SCI impacts function and health outcomes, (2) analyze the neuroplastic effects of RGT dose, and (3) evaluate the safety, tolerability, and feasibility of delivering RGT.

Methods: We will enroll 144 participants with motor incomplete SCI admitted to inpatient rehabilitation within 6 months of SCI. Participants will be randomized based on injury severity and level into one of 3 RGT frequency groups (high, moderate, low) or none/usual care only. Participants will complete 24 RGT sessions and be assessed at admission and discharge to inpatient rehabilitation, post-RGT intervention, 1-month post-RGT, and 9-month post-SCI. Outcomes include Walking Index for Spinal Cord Injury-II, health outcomes (gait speed, Spinal Cord Independence Measure, pain, fatigue, spasticity, general health, quality of life, physical activity), and motor evoked potential amplitudes obtained using transcranial magnetic stimulation.

Discussion: Successful completion of this study will provide an evidence-based intervention, specifically tailored to meet the unique needs of people with SCI, which supports walking recovery; maximizing health, function, and ultimately participation. The intervention will further support widespread clinical implementation of exoskeleton use during acute rehabilitation.

Trial registration: ClinicalTrials.gov NCT05218447. Registered on June 23, 2022.

Keywords: Clinical trial; Gait; Rehabilitation; Robotic gait training; Spinal cord injury.

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Conflict of interest statement

The authors declare that they have no competing interests.

References

    1. Jain NB, Ayers GD, Peterson EN, et al. Traumatic spinal cord injury in the United States, 1993–2012. JAMA. 2015;313(22):2236–43. - PMC - PubMed
    1. Ditunno P, Patrick M, Stineman M, Ditunno J. Who wants to walk? Preferences for recovery after SCI: a longitudinal and cross-sectional study. Spinal cord. 2008;46(7):500–6. - PubMed
    1. Geisler FH, Dorsey FC, Coleman WP. Recovery of motor function after spinal-cord injury—a randomized, placebo-controlled trial with GM-1 ganglioside. N Engl J Med. 1991;324(26):1829–1838. - PubMed
    1. Swank C, Galvan C, DiPasquale J, et al. Lessons learned from robotic gait training during rehabilitation: therapeutic and medical severity considerations over 3 years. Technol Disabil. 2020;32(2):103–10.
    1. Swank C, Sikka S, Driver S, Bennett M, Callender L. Feasibility of integrating robotic exoskeleton gait training in inpatient rehabilitation. disability and rehabilitation. Assist Technol. 2019;15(4):409–17 1–9. - PubMed

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