Multicentric investigation on the safety, feasibility and usability of the ABLE lower‑limb robotic exoskeleton for individuals with spinal cord injury: a framework towards the standardisation of clinical evaluations

Journal of NeuroEngineering and Rehabilitation, 2023 · DOI: https://doi.org/10.1186/s12984-023-01165-0 · Published: April 1, 2023

Spinal Cord Injury Assistive Technology

Simple Explanation

This study evaluates the ABLE Exoskeleton for individuals with spinal cord injury (SCI). The focus is on safety, feasibility, and usability in clinical settings. The ABLE Exoskeleton is a lower-limb robotic device. It is designed to aid walking and rehabilitation for people with SCI. The research aims to standardize clinical evaluations of exoskeletons. This allows better comparison between different devices and studies.

Study Duration

4–6 weeks training, 4 week follow up

Participants

24 participants with SCI (C5 to L3)

Evidence Level

Quasi-experimental study

Key Findings

1
The ABLE Exoskeleton is safe and feasible for gait training in SCI patients. Few device-related adverse events were reported, mainly mild skin lesions and pain.
2
Participants showed improvements in gait parameters (time, steps, distance, speed). They also showed improved walking function and reduced perceived exertion.
3
The exoskeleton had a positive psychosocial impact. Satisfaction with the device was generally good, especially regarding safety and durability.

Research Summary

This multicenter study assessed the ABLE Exoskeleton's safety, feasibility, and usability for SCI patients during a 4–6-week training program. Results indicated safe gait training with improved clinical outcomes. The study protocol allows for consistent comparison with other exoskeleton trials. The ABLE Exoskeleton demonstrated potential for improving gait and function. It also showed a positive impact on users' psychosocial well-being and satisfaction.

Practical Implications

Clinical Practice

The ABLE Exoskeleton can be safely used in clinical settings for gait training of SCI patients, improving walking ability and reducing dependency on walking aids.

Research Standardization

The study's protocol can serve as a framework for future exoskeleton trials, enabling more consistent and comparable results across different devices and studies.

Device Improvement

Feedback from participants and therapists can be used to further refine the design and functionality of the ABLE Exoskeleton, enhancing its usability and effectiveness.

Study Limitations

1
Open, non-blinded study with potential for selection bias.
2
Heterogeneity of study population and small sample size.
3
Lack of a control group makes it difficult to establish a causal relationship between exoskeleton use and observed improvements.

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