Hands-free Exoskeleton for Spinal Cord Injury

Overseen By Brian Saba

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

10 Participants Needed

Trial Summary

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).

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, and their effectiveness improves with more training sessions. Additionally, exoskeletons have been shown to improve hand function in individuals with spinal cord injuries, suggesting potential benefits for overall mobility. ^{1 2 3 4 5}

Is the hands-free exoskeleton generally safe for humans?

The hands-free exoskeleton has been studied for safety in people with spinal cord injuries. While it can be safe and feasible, some users experienced low blood pressure, and there were rare cases of bone fractures. Extra safety measures and training are recommended to minimize risks. ^{3 6 7 8 9}

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

The hands-free exoskeleton treatment is unique because it allows individuals with spinal cord injuries to walk using a robotic device without needing to use their hands, which is different from other treatments that may require manual control or assistance. This approach can enhance mobility and independence for those with severe disabilities. ^{3 10 11 12 13}

Eligibility Criteria

This trial is for adults over 18 with spinal cord injury (SCI) at or above T6, who are at least 6 months post-injury. Participants must live in the US, speak English, and be able to consent. They should attend multiple training sessions with a companion who also meets similar criteria. Excluded are those with severe diseases, certain bone density issues, untreated conditions like hypertension or spasticity, pregnancy, participation in other trials, and inability to fit or operate the exoskeleton.

Inclusion Criteria

I am willing to attend 9-10 visits for training and assessments with the SCI user.

I am 18 or older and use a spinal cord injury program.

I have been living with a spinal cord injury for at least 6 months.

Exclusion Criteria

SCI user: Severe concurrent medical disease, illness or condition judged to be contraindicated by the site physician

SCI user: Total hip BMD T-scores < -3.5

SCI user: Untreatable severe spasticity judged to be contraindicated by the site physician

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, including assessments of safety, health benefits, and satisfaction

1 week

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Hands-free exoskeleton

Trial Overview The study tests a hands-free personal exoskeleton's safety and effectiveness for individuals with SCI. It involves training sessions where participants learn to use the device under supervision to assess its impact on their mobility and daily living activities.

Participant Groups

Group I: Hands-free exoskeleton Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Wandercraft

Lead Sponsor

Trials

10

Recruited

310+

Findings from Research

A 51-year-old man with a C6 spinal cord injury showed significant improvements in hand function after 20 sessions of robot-assisted training over 10 weeks, with grip force increasing from 13.5 to 19.6 kg.

The training, which utilized myoelectric pattern recognition to assist hand movements, resulted in faster task completion and improved scores on functional tests, demonstrating the effectiveness of this rehabilitation approach for spinal cord injury patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic Hand-Assisted Training for Spinal Cord Injury Driven by Myoelectric Pattern Recognition: A Case Report. Lu, Z., Tong, KY., Shin, H., et al.[2017]

The Berlin Bimanual Test for Tetraplegia (BeBiTT) is a reliable and valid tool for assessing bimanual hand function in individuals with cervical spinal cord injury, showing excellent interrater reliability and strong correlations with established measures of independence.

Using a brain/neural hand exoskeleton significantly improved participants' performance on the BeBiTT, indicating that this assistive technology can effectively enhance bimanual task performance in individuals with tetraplegia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Berlin Bimanual Test for Tetraplegia (BeBiTT): development, psychometric properties, and sensitivity to change in assistive hand exoskeleton application. Angerhöfer, C., Vermehren, M., Colucci, A., et al.[2023]

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]

Wearable exoskeletons have not been shown to improve lower extremity function or gait compared to knee-ankle-foot orthoses (KAFOs) in patients with spinal cord injuries, as no studies were found that directly compared these two assistive devices.

In rehabilitation settings, the effectiveness of exoskeletons compared to traditional therapies is inconsistent, with some studies showing no difference in outcomes, while others suggest varying benefits, indicating a need for further research on newer exoskeleton models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness and Safety of Exoskeletons as Assistive and Rehabilitation Devices in the Treatment of Neurologic Gait Disorders in Patients with Spinal Cord Injury: A Systematic Review. Fisahn, C., Aach, M., Jansen, O., et al.[2020]

Only 30% of the 40 reviewed clinical trials on acute spinal cord injury provided satisfactory reporting of adverse events, indicating a significant gap in safety information that is crucial for assessing risk and designing future studies.

A staggering 82.5% of trials failed to report laboratory-defined toxicity satisfactorily, highlighting the need for improved standards in safety reporting to ensure comprehensive understanding of treatment risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Safety Reporting in Acute Spinal Cord Injury Clinical Trials: Challenges and Recommendations. Aspinall, P., Harrison, L., Scheuren, P., et al.[2023]

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]

Two cases of bone fractures were reported during the use of powered robotic exoskeletons in patients with spinal cord injury, highlighting the potential risks associated with unexpected technical failures.

Proper alignment of the exoskeleton with the user's body is crucial to minimize fracture risks, and additional safety training is recommended for both patients and instructors to handle emergency situations effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case Report: Description of two fractures during the use of a powered exoskeleton. van Herpen, FHM., van Dijsseldonk, RB., Rijken, H., et al.[2023]

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 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]

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 Exo-Glove Poly (EGP) II is a soft wearable robot designed to help individuals with spinal cord injuries regain the ability to pinch and grasp objects, enhancing their daily life activities.

In tests with two subjects, the glove's design, which includes a passive thumb structure and a compact actuator system, demonstrated effective grasping performance while being lightweight and adaptable to various hand sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exo-Glove Poly II: A Polymer-Based Soft Wearable Robot for the Hand with a Tendon-Driven Actuation System. Kang, BB., Choi, H., Lee, H., et al.[2020]

A user-controlled textile-based soft robotic glove significantly improved hand function in 13 participants with tetraplegia, allowing them to complete 50% more tasks in daily living activities compared to their baseline performance without the glove.

The glove also enhanced grasp strength and active range of motion in the fingers, with participants who had lower baseline motor function experiencing the greatest benefits, highlighting its potential as a valuable assistive device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Grasp Function After Spinal Cord Injury With a Soft Robotic Glove. Correia, C., Nuckols, K., Wagner, D., et al.[2021]

References

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

Robotic Hand-Assisted Training for Spinal Cord Injury Driven by Myoelectric Pattern Recognition: A Case Report. [2017]

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

The Berlin Bimanual Test for Tetraplegia (BeBiTT): development, psychometric properties, and sensitivity to change in assistive hand exoskeleton application. [2023]

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

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

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

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

5. England pubmed.ncbi.nlm.nih.gov

The Effectiveness and Safety of Exoskeletons as Assistive and Rehabilitation Devices in the Treatment of Neurologic Gait Disorders in Patients with Spinal Cord Injury: A Systematic Review. [2020]

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

A Systematic Review of Safety Reporting in Acute Spinal Cord Injury Clinical Trials: Challenges and Recommendations. [2023]

7. 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]

8. England pubmed.ncbi.nlm.nih.gov

Case Report: Description of two fractures during the use of a powered exoskeleton. [2023]

9. 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]

10. 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]

11. 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]

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

Exo-Glove Poly II: A Polymer-Based Soft Wearable Robot for the Hand with a Tendon-Driven Actuation System. [2020]

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

Improving Grasp Function After Spinal Cord Injury With a Soft Robotic Glove. [2021]