Considering an Exoskeleton? Don't Ignore this Crucial Factor

As a physical therapist and Indego instructor, I’m frequently asked, “Will the Indego really benefit me?” and “What improvements can I expect?” My best response involves referencing clinical research data on the subject, steering the conversation to an evidence-based discussion of what improvements users have experienced. In short, when making your decision, don’t overlook research data.

I have summarized the findings of a review titled Systematic review on wearable lower-limb exoskeletons for gait training in neuromuscular impairments, by Rodriguez-Fernandez, et al. published in February 2021. The systematic review covers the Indego exoskeleton and its competitors. My objective is to explain the benefits and limitations of exoskeletons, based on the evidence to date.

Criteria

When Considering Purchasing an Exoskeleton, Don’t Overlook this Crucial FactorThe systematic review analyzed 87 studies conducted between 2009 and 2019 and focused on wearable lower-limb exoskeletons for over-ground gait training.

Inclusion criteria:

  • Use a wearable, powered, lower-limb exoskeleton

  • Report over-ground outcome measures

  • Include users with a neuromuscular disorder

Exclusion criteria:

  • Soft exoskeletons or exo suits

  • Body-weight support systems or treadmill training

Findings

The review focused on three key questions:

1. What is the current technological status of wearable lower-limb exoskeletons for gait rehabilitation?

  • They remain bulky and heavy, require supervision, can be difficult to don and doff, and require use of walking aids which can hinder mobility and independence.

  • Joint misalignments and improper fit can increase the metabolic costs, create discomfort and generate skin abrasions or risk of fractures.

  • The cost for personal devices must be reduced. The vast majority of potential users are unable to afford them.

2. What is the methodology used in clinical validations of wearable lower limb exoskeletons?

  • Validation studies are currently in their early stages. Evidence is limited to short intervention trials with few participants.

  • Protocol design variability combined with outcome measure variability hinders benchmarking.

  • There is a great need for experimental studies using control groups to obtain stronger evidence on clinical effectiveness.

  • The majority of outcome measures are focused on ambulation assessments rather than on physiological and psychological changes.

  • Future studies in spinal cord injury should focus on assessing the impact of exoskeleton therapy on outcomes related to secondary health conditions.

3. What are the benefits and current evidence on clinical efficacy of wearable lower-limb exoskeletons?

  • They promote health benefits including improved blood circulation, reflex activity, and bowel and bladder function.

  • Exoskeletons activate mechanisms of neuroplasticity and re-connectivity which promote motor function recovery in individuals following spinal cord injury and stroke.

  • They provide opportunities to stand and socialize at eye level.

  • People with spinal cord injuries are the main users.

  • People following stroke present the most reliable and promising results in terms of rehabilitation outcomes compared with traditional gait therapy.

  • Randomized control trials are needed to demonstrate effectiveness as a rehabilitation device and their impact on psychological and physiological secondary health conditions.

Key Performance and Clinical Evidence Details

Spinal Cord Injury

  • Twenty-one studies compared outcome measures before and after exoskeleton training. Nineteen of these reported that functional mobility improved.

  • No randomized control trials comparing lower limb exoskeletons vs. traditional gait training have been performed. This is a significant limitation in the body of evidence to date.

Stroke

  • Sixteen studies compared gait performance before and after exoskeleton training. Twelve reported improvements, one reported a negative change, and three reported no change in gait performance. Three out of nine studies showed improvements to Fugl-Meyer following exoskeleton training.

  • Five randomized control trials including 183 patients were identified. Four out of five studies report significant improvements in measures like gait speed, step length, spatial symmetry, Functional Ambulation Categories (FAC scores), corticospinal excitability, and muscle activation following rehabilitation using an exoskeleton. In addition, FAC scores were maintained at two and three months follow up assessments in two different studies.

Other Pathologies

  • Four out of seven studies showed an improvement in gait speed.

Exoskeletons included in the literature review

When Considering Purchasing an Exoskeleton, Don’t Overlook this Crucial Factor

The systematic review concludes that exoskeletons are safe and effective tools for gait training following neuromuscular impairment. However, effort should be invested in creating exoskeletons that are:

  • Lightweight and easy to use

  • Validated through well-defined protocols to provide the best rehabilitation possible and the opportunity for benchmarking

Systematic review on wearable lower-limb exoskeletons for gait training in neuromuscular impairments. Antonio Rodriguez-Fernandez, et al. J NeuroEngineering Rehabilitation (2021) 18:22 is available here: https://jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-021-00815-5.

Pro Tip: Stay up to date on new clinical research by signing up for free email notifications at https://www.ncbi.nlm.nih.gov/.

About the Author:

When Considering Purchasing an Exoskeleton, Don’t Overlook this Crucial FactorRobert McCloskey is a physical therapist, Indego Instructor, and the co-founder and Chief Care Officer at Next Level Rehab in Asheville, North Carolina. Robert earned his Bachelor of Science degree in Biology from Georgia Southern University, and his Doctor of Physical Therapy degree from the University of Kansas Medical Center. Robert has a background in treating individuals with neuromuscular disorders and traumatic brain injuries. Haley McCloskey is a sales and marketing professional who handles day-to-day operations at Next Level Rehab. She is responsible for connecting with healthcare professionals and patient advocates to expand their reach throughout the community. Next Level Rehab offers Indego-centered rehabilitation and wellness services, special event services, and Indego personal screening and training services. To learn more, visit www.NextLevelRehabAsheville.com.

 

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