Exoskeleton for Spinal Cord Injury

Overseen By David Kim

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wandercraft

Disqualifiers: Neurological injury, Severe disease, Fractures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

24 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Hands-free exoskeleton for spinal cord injury?

Research shows that powered exoskeletons can help people with spinal cord injuries walk at modest speeds, especially with more training. This suggests that exoskeletons can be effective in improving mobility for those with spinal cord injuries. ^{1 2 3 4 5}

Is the exoskeleton for spinal cord injury safe for humans?

Research shows that exoskeletons can be safe for people with spinal cord injuries, but there are some risks like low blood pressure events. It's important to have safety measures in place to reduce these risks. ^{1 3 6 7 8}

How does the hands-free exoskeleton treatment for spinal cord injury differ from other treatments?

The hands-free exoskeleton is unique because it allows individuals with spinal cord injuries to walk using a robotic device that supports and moves their legs, unlike traditional therapies that may focus on physical therapy or passive support. This exoskeleton provides active assistance, enabling more natural movement and potentially improving rehabilitation outcomes. ^{1 9 10 11 12}

What is the purpose of this trial?

This study aims to demonstrate the safety and effectiveness of the personal exoskeleton in individuals with spinal cord injury (SCI).

Eligibility Criteria

This trial is for adults over 18 living in the US with spinal cord injuries at or above T6, who are at least 6 months post-injury. Participants must be able to attend multiple training sessions and operate the device using a hand-control interface. Exclusions include severe medical conditions, pregnancy, leg discrepancies over 2 cm, untreated severe spasticity or hypertension, unstable fractures, and those with open skin sores.

Inclusion Criteria

I can attend 9-10 visits at the center for training and assessments.

Able to read, understand, and provide informed consent

It has been over 6 months since my spinal cord injury.

Exclusion Criteria

My legs are different lengths by more than 2 cm.

Morphological contraindications to the use of the device

I cannot use devices controlled by hand.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Device Fitting and Training

Participants undergo device fitting and five training sessions to learn basic skills with the exoskeleton, concluding with a competency evaluation.

2-3 weeks

6 visits (in-person)

Effectiveness Evaluation

Participants are evaluated on the effectiveness of the exoskeleton through various tests, including the 10-Meter Walk Test and Timed Up and Go.

1 week

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the main training and evaluation phases.

1 week

Treatment Details

Interventions

• Hands-free exoskeleton

Trial Overview The study tests a hands-free exoskeleton's safety and effectiveness for individuals with spinal cord injury. It involves attending several visits for training and assessments to see how well participants can use this personal mobility device.

Participant Groups

Group I: Hands-free exoskeleton Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Wandercraft

Lead Sponsor

Trials

10

Recruited

310+

James J. Peters Veterans Affairs Medical Center

Collaborator

Trials

59

Recruited

2,900+

Findings from Research

The study involving 11 participants with acute spinal cord injuries demonstrated that exoskeletal-assisted walking is safe, with no serious adverse events reported during up to 25 training sessions.

Participants showed significant improvements in walking distance and speed, indicating that this intervention is feasible and effective for enhancing mobility in individuals less than 6 months post-injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety and Feasibility of Exoskeletal-Assisted Walking in Acute Rehabilitation After Spinal Cord Injury. McIntosh, K., Charbonneau, R., Bensaada, Y., et al.[2020]

Powered robotic exoskeletons enable non-ambulatory individuals with spinal cord injuries (SCI) to walk, achieving a mean gait speed of 0.26 m/s, particularly among those with thoracic-level motor-complete injuries.

Factors such as age, injury level, and the number of training sessions positively influence gait speed, indicating that more training can lead to better walking outcomes for users of powered exoskeletons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait speed using powered robotic exoskeletons after spinal cord injury: a systematic review and correlational study. Louie, DR., Eng, JJ., Lam, T.[2018]

This study developed a musculoskeletal model to analyze upper extremity biomechanics in individuals with complete spinal cord injury using a powered exoskeleton and crutches, revealing that these users experience significantly higher joint loads compared to those with incomplete SCI.

The findings suggest that prolonged crutch use during exoskeleton walking leads to increased upper extremity joint impulses, which could raise the risk of overuse injuries; thus, improving device design and training methods is crucial for reducing these risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Estimating upper extremity joint loads of persons with spinal cord injury walking with a lower extremity powered exoskeleton and forearm crutches. Smith, AJJ., Fournier, BN., Nantel, J., et al.[2021]

A feasibility study involving 10 individuals with chronic spinal cord injury showed that while exoskeleton training improved walking speeds and distances, only 5 out of 10 participants completed the program due to challenges like ineligibility and lack of interest.

Participants experienced some skin issues (grade I/II aberrations), highlighting the need for careful monitoring of medical complications when using exoskeletons for rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lower-limb exoskeletons for individuals with chronic spinal cord injury: findings from a feasibility study. Benson, I., Hart, K., Tussler, D., et al.[2018]

A concordance table was developed to estimate Spinal Cord Injury Functional Index Assistive Technology (SCI-FI/AT) scores from FIM motor item scores, allowing researchers to combine data from both assessments for better analysis of functional outcomes in individuals with spinal cord injuries.

The study found that while the estimated SCI-FI/AT scores correlated well with actual scores (Pearson correlation of 0.79), caution is advised when interpreting scores for individuals with cervical-level injuries, as greater discrepancies were noted in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Concordance Table to Convert FIM Basic Mobility and Self-Care Scale Scores to SCI-FI/AT Scores. Ni, P., Spellman, K., Zafonte, R., et al.[2022]

A study involving 12 participants with acute/sub-acute spinal cord injuries showed that using powered exoskeletons for locomotor training is generally safe, although symptomatic hypotension was the most common adverse event reported.

The feasibility of using exoskeletons was demonstrated, with 54% protocol compliance and 58% of participants achieving at least minimal assistance during walking sessions, indicating potential for effective rehabilitation in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and feasibility of exoskeleton-assisted walking during acute/sub-acute SCI in an inpatient rehabilitation facility: A single-group preliminary study. Delgado, AD., Escalon, MX., Bryce, TN., et al.[2021]

Powered exoskeletons, like the ReWalk™, Indego™, and Ekso™, have been approved as medical devices to help individuals with gait disabilities walk upright, but the understanding of their risks and safety is still developing.

There is a significant need for standardized regulations and awareness of potential risks associated with powered exoskeletons to ensure safe and effective use, as current criteria for their use and reported adverse events vary widely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk management and regulations for lower limb medical exoskeletons: a review. He, Y., Eguren, D., Luu, TP., et al.[2020]

Powered exoskeletons have been shown to enable 76% of patients with spinal cord injury to walk independently after training, with sessions typically lasting 60-120 minutes, three times a week for up to 24 weeks.

The training was safe, with a low incidence of falls (4.4%) and fractures (3.4%), and no serious adverse events reported, indicating that newer exoskeleton designs have improved safety features.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical effectiveness and safety of powered exoskeleton-assisted walking in patients with spinal cord injury: systematic review with meta-analysis. Miller, LE., Zimmermann, AK., Herbert, WG.[2022]

The motor-augmented wrist-driven orthosis (MWDO) enhances grasping ability for individuals with C6-C7 spinal cord injuries by combining both body-powered and motorized actuation, allowing for more flexible and dexterous hand movements.

The MWDO features a control scheme that decouples wrist and finger movements, along with a magnetic latch at the finger joint, improving the ability to perform daily activities like pinching and grasping.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor-Augmented Wrist-Driven Orthosis: Flexible Grasp Assistance for People with Spinal Cord Injury. McPherson, AIW., Patel, VV., Downey, PR., et al.[2020]

A novel controller that monitors head position to control hand movements in three-dimensional space was tested, showing effectiveness in helping individuals with upper limb disabilities perform tracking tasks.

Out of 18 subjects, including 13 with spinal cord injuries, most were able to use the controller effectively after minimal training, suggesting its potential for aiding those with upper limb amputation or paralysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel five degree of freedom user command controller in people with spinal cord injury and non-injured for full upper extremity neuroprostheses, wearable powered orthoses and prosthetics. Scott, TR., Vare, VA.[2021]

The study introduced an innovative intraoral tongue-computer interface (ITCI) that allows individuals with tetraplegia to control a five-degree-of-freedom upper-limb exoskeleton, enabling them to perform tasks like drinking with minimal training (only 2 hours).

Participants, including a clinical case study, demonstrated the ability to control the exoskeleton effectively, achieving performance speeds that were only slightly slower than able-bodied individuals, even without visual feedback, showcasing the potential for independence in daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eyes-Free Tongue Gesture and Tongue Joystick Control of a Five DOF Upper-Limb Exoskeleton for Severely Disabled Individuals. Mohammadi, M., Knoche, H., Thøgersen, M., et al.[2022]

The FLEXotendon Glove-III, a soft robotic hand exoskeleton, was evaluated in a case study with two individuals with cervical spinal cord injury, using standardized tests to measure hand function improvements.

Design enhancements, such as fingertip force sensors and a redesigned smartphone app, were implemented to improve user experience and safety during rehabilitation, indicating a focus on both efficacy and user satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the FLEXotendon glove-III through a human subject case study. Tran, P., Elliott, D., Herrin, K., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Safety and Feasibility of Exoskeletal-Assisted Walking in Acute Rehabilitation After Spinal Cord Injury. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Gait speed using powered robotic exoskeletons after spinal cord injury: a systematic review and correlational study. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Estimating upper extremity joint loads of persons with spinal cord injury walking with a lower extremity powered exoskeleton and forearm crutches. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Lower-limb exoskeletons for individuals with chronic spinal cord injury: findings from a feasibility study. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

A Concordance Table to Convert FIM Basic Mobility and Self-Care Scale Scores to SCI-FI/AT Scores. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Safety and feasibility of exoskeleton-assisted walking during acute/sub-acute SCI in an inpatient rehabilitation facility: A single-group preliminary study. [2021]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Risk management and regulations for lower limb medical exoskeletons: a review. [2020]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Clinical effectiveness and safety of powered exoskeleton-assisted walking in patients with spinal cord injury: systematic review with meta-analysis. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Motor-Augmented Wrist-Driven Orthosis: Flexible Grasp Assistance for People with Spinal Cord Injury. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

A novel five degree of freedom user command controller in people with spinal cord injury and non-injured for full upper extremity neuroprostheses, wearable powered orthoses and prosthetics. [2021]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Eyes-Free Tongue Gesture and Tongue Joystick Control of a Five DOF Upper-Limb Exoskeleton for Severely Disabled Individuals. [2022]

12. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of the FLEXotendon glove-III through a human subject case study. [2023]