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

Trials, 2024 · DOI: https://doi.org/10.1186/s13063-024-08503-0 · Published: September 23, 2024

Simple Explanation

This study aims to determine the optimal frequency of robotic exoskeleton gait training (RGT) for individuals with motor incomplete spinal cord injury (SCI). It will investigate how different RGT frequencies affect function, health outcomes, and neuroplasticity. The study involves 144 participants with motor incomplete SCI, who will be randomized into different RGT frequency groups (high, moderate, low) or a usual care group. They will undergo 24 RGT sessions. The outcomes measured include walking performance, gait speed, spinal cord independence, pain, fatigue, spasticity, quality of life, physical activity, and motor evoked potential amplitudes using transcranial magnetic stimulation.

Study Duration

9 Months

Participants

144 participants with motor incomplete SCI

Evidence Level

Level 1, Randomized controlled trial

Key Findings

1
The study aims to provide evidence-based interventions tailored for people with SCI to support walking recovery and maximize health, function, and participation.
2
The research will examine whether the dosing frequency of RGT therapy impacts functional and patient-reported outcomes during the acute/subacute rehabilitation phase after motor incomplete SCI.
3
The study will evaluate the safety, tolerability, and feasibility of delivering different dosing frequencies of RGT from inpatient to outpatient rehabilitation settings.

Research Summary

This study protocol outlines a randomized clinical trial to investigate the optimal dosing frequency of robotic gait training (RGT) for individuals with motor incomplete spinal cord injury (SCI). The trial will enroll 144 participants who will be randomized into high, moderate, low RGT frequency groups, or a usual care group. Outcomes will be assessed at multiple time points to evaluate functional and neuroplastic changes. The expected results will provide evidence-based interventions to improve walking recovery and overall health in individuals with SCI, supporting the widespread clinical implementation of exoskeleton use during rehabilitation.

Practical Implications

Clinical Practice

The findings will directly impact rehabilitation clinical practice and patient outcomes for people with motor incomplete SCI by providing efficacy data concerning the dose of RGT.

Rehabilitation Programs

The intervention will further support widespread clinical implementation of exoskeleton use during acute rehabilitation, tailoring programs to meet unique needs.

Walking Recovery

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.

Study Limitations

1
The RGT intervention depends on the participants’ motivation, adherence, and commitment to fully engage in the trial.
2
The trial focuses specifically on motor incomplete SCI, limiting the generalizability to other types of SCI.
3
The study is conducted at a single site, which may affect the generalizability of the findings to other settings.

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