Foundational ingredients of robotic gait training for people with incomplete spinal cord injury during inpatient rehabilitation (FIRST): A randomized controlled trial protocol

PLOS ONE, 2022 · DOI: https://doi.org/10.1371/journal.pone.0267013 · Published: May 10, 2022

Simple Explanation

This study aims to develop and test a robotic gait training program for individuals with incomplete spinal cord injuries during their inpatient rehabilitation. The program will be designed with input from patients, caregivers, clinicians, and researchers to ensure it meets their needs. The study will compare the robotic gait training program to usual care gait training to see if it improves walking function and other outcomes.

Study Duration

Between April 2021 and August 2023

Participants

128 patients with incomplete SCI

Evidence Level

Randomized controlled trial

Key Findings

1
The primary outcome is gait function as characterized by the Walking Index for Spinal Cord Injury–II (WISCI-II).
2
Secondary outcomes include gait speed, Spinal Cord Independence Measure (SCIM), Numeric Pain Rating Scale (NPRS), and other measures of fatigue, spasm frequency, and quality of life.
3
The study will also compare the intensity of robotic gait training and usual care gait training by measuring heart rate, perceived exertion, and number of steps.

Research Summary

This study protocol outlines a randomized controlled trial to evaluate the efficacy of a stakeholder-informed robotic gait training (RGT) program compared to usual care gait training (UC) for individuals with incomplete spinal cord injury (SCI) during inpatient rehabilitation. The primary outcome is gait function measured by the Walking Index for Spinal Cord Injury–II (WISCI-II), with secondary outcomes including gait speed, functional independence, pain, fatigue, and quality of life. The study will also compare the intensity of RGT and UC gait training based on heart rate, perceived exertion, and number of steps to determine if RGT can provide a more effective training stimulus.

Practical Implications

Clinical Practice

Successful completion of this study will provide a usable and replicable RGT intervention for individuals with incomplete SCI during inpatient rehabilitation.

Future Research

The study will provide foundational evidence for the use of robotic exoskeletons during the acute phase of recovery from SCI.

Technology Development

The study may inform the design and implementation of robotic exoskeleton technology for SCI rehabilitation.

Study Limitations

1
Participants will not be blinded to group assignment.
2
The study is limited to individuals with incomplete SCI who meet specific criteria for robotic exoskeleton use.
3
The study will be conducted at a single rehabilitation hospital, which may limit the generalizability of the findings.

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