Exoskeleton + Spinal Cord Stimulation for Spinal Cord Injury

Overseen By Gail F Forrest, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Disqualifiers: Bone fractures, Bone trauma, Bone disease

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 28 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether combining spinal cord stimulation with exoskeleton-assisted walking can help people with spinal cord injuries improve their walking ability. Participants will either walk with an exoskeleton and receive additional spinal stimulation or use only the exoskeleton. The goal is to determine which method more effectively aids walking recovery. Ideal participants have had a spinal cord injury for over six years, rely entirely on a wheelchair, and have some leg movement. As an unphased trial, this study offers participants a unique opportunity to contribute to groundbreaking research that could enhance mobility solutions for spinal cord injuries.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this exoskeleton-assisted walking and transcutaneous lumbosacral stimulation are safe for spinal cord injury patients?

Research shows that using an exoskeleton to assist people with spinal cord injuries in walking is generally safe. Studies indicate it can be used safely in everyday situations and aids in rehabilitation. People who have recently been injured can benefit from this training without major safety concerns.

For transcutaneous lumbosacral stimulation (TLS), research also suggests it is safe. TLS uses small electric pulses on the back to help with muscle control. Studies have shown it aids recovery after a spinal cord injury and is non-invasive, meaning it doesn't require surgery. This makes it a safer option for many people.

Both treatments have been well-tolerated in past studies, with no significant adverse events reported. This means they did not cause serious side effects for those who tried them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they combine exoskeleton-assisted walking with transcutaneous lumbosacral stimulation (TLS), offering a new approach for spinal cord injury rehabilitation. Unlike traditional therapies that primarily focus on physical therapy and rehabilitation exercises, this method uses advanced technology to stimulate the spinal cord directly. The exoskeleton helps individuals walk, while the TLS delivers electrical pulses to enhance nerve activity and muscle reflexes. This innovative combination could improve mobility and recovery outcomes beyond what current treatments achieve.

What evidence suggests that this trial's treatments could be effective for spinal cord injury?

Studies have shown that using an exoskeleton to assist walking can help people with spinal cord injuries improve their walking ability. This therapy aids movement in everyday settings and can also enhance mental health. In this trial, one group of participants will receive exoskeleton-assisted walking combined with transcutaneous lumbosacral stimulation (TLS), a technique that uses electrical signals to stimulate the spinal cord and enhance recovery and walking ability. Another group will receive exoskeleton-assisted walking without TLS. Combining TLS with exoskeleton-assisted walking might lead to even better results, as TLS has been shown to improve movement and aid recovery. Both treatments are considered safe and have the potential to help those with spinal cord injuries regain movement. ^{1 2 3 6 7}

Who Is on the Research Team?

Gail F Forrest, PhD

Principal Investigator

Kessler Foundation

Are You a Good Fit for This Trial?

This trial is for adults aged 21-58 who are wheelchair reliant due to a spinal cord injury (SCI) that occurred over 6 years ago. Participants must be between 62 and 74 inches tall, have some lower limb movement, and no history of bone fractures or diseases.

Inclusion Criteria

My spinal cord injury is between my neck and mid-back.

I use a wheelchair all the time.

I am between 21 and 58 years old.

Exclusion Criteria

I have had bone disease or injury in the past.

I have had broken bones in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Evaluation

Initial evaluation including stand evaluation and instruction in proper use of the exoskeleton device

1 week

1 visit (in-person)

Treatment

Participants receive 60 minutes of exoskeleton-assisted walking with or without TLS for 80 sessions over 28 weeks

28 weeks

3 visits per week (in-person)

Follow-up

Participants are monitored for changes in walking ability, balance, and other health metrics

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exoskeleton-Assisted Walking
• Transcutaneous Lumbosacral Stimulation (TLS)

Trial Overview The study is testing if using transcutaneous lumbosacral stimulation (TLS) while walking with an exoskeleton helps improve walking ability in people with SCI compared to just using the exoskeleton alone.

How Is the Trial Designed?

Group I: EAW without TLS Experimental Treatment 1 Intervention

EAW, exoskeleton-assisted walking, an activity based therapy is a training which involves using the same exoskeleton device for all the participants. Each participant will undergo, 60 minutes of EAW as above. Each participant will undergo a stand evaluation and be instructed in proper use of the device. During the initial 3 sessions of training, the exoskeleton device will be tethered to an overhead pulley system during training to allow subjects to safely adapt to trunk, balance gait activities while walking in the exoskeleton. EAW overground walking will follow each training session with the 6-minute walk test, 10 meter walk test .

Group II: EAW + TLS Experimental Treatment 2 Interventions

The EAW+TLS training group will receive 60 minutes of exoskeleton-assisted walking overground per session, for a total of 80 sessions (3x/week, 28 wks.) with simultaneous transcutaneous lumbosacral stimulation (TLS) intervention followed by 15 minutes of over ground training without the exoskeleton. component is added to the exoskeleton assisted walking component in this group. TLS will involve placing self-adhesive stimulating electrodes bilaterally over the T11/T12 lumbar region. Correct placement will be confirmed by the elicitation of posterior root muscle reflexes in the lower limb muscles. A constant-voltage stimulator (RT 50 Sage stimulator) will deliver pulses of 2 ms width. TLS will be applied while the participant walks in the Exo-skeleton-assisted walking (EAW).

Exoskeleton-Assisted Walking is already approved in United States for the following indications:

Approved in United States as ReWalk for:

• Spinal cord injury (SCI) levels T7 to L5
• Stroke rehabilitation

Approved in United States as Ekso GT for:

• Spinal cord injuries at levels T4 to L5
• Hemiplegia due to stroke
• Spinal cord injuries at levels C7 to T3

Approved in United States as Indego for:

• Spinal cord injury (SCI) levels T7 to L5
• Rehabilitation institutions

Approved in United States as ReWalk ReStore for:

• Rehabilitation of individuals with lower-limb disabilities due to stroke

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

Kessler Institute for Rehabilitation

Industry Sponsor

Trials

23

Recruited

1,100+

Published Research Related to This Trial

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]

A review of 63 studies highlights that nearly half of the challenges in implementing powered exoskeleton training for spinal cord injury patients are related to the characteristics of the intervention itself, such as high rates of adverse events and device malfunctions.

Successful implementation of powered exoskeleton training relies on adequate clinician training, available resources, and clear communication about patient expectations, indicating that addressing these factors could enhance rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the determinants of implementation of a locomotor training program using a powered exoskeleton for individuals with a spinal cord injury. Charette, C., Déry, J., Blanchette, AK., et al.[2023]

A study involving 19 individuals with chronic spinal cord injury showed that combining spinal cord electrical stimulation (SCES) with exoskeleton walk training (EWT) significantly improved foot loading forces and reduced asymmetry in walking, with 8 out of 19 participants showing improved ambulation.

Participants reported enhanced sensations and neurological improvements, including increased tactile and pain sensations, suggesting that SCES may activate locomotor networks and enhance the effectiveness of rehabilitation compared to EWT alone, which had limited results in a control group of 16 individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exoskeleton Walk Training in Paralyzed Individuals Benefits From Transcutaneous Lumbar Cord Tonic Electrical Stimulation. Shapkova, EY., Pismennaya, EV., Emelyannikov, DV., et al.[2020]

Training with the Hybrid Assistive Limb (HAL) exoskeleton for 90 days significantly improved walking time, distance, and speed in eight chronic paraplegic patients after spinal cord injury, indicating its efficacy in enhancing functional mobility.

Patients also showed improvements in over-ground walking abilities, as evidenced by better scores in various functional tests, and one patient even improved from ASIA B to ASIA C on the impairment scale, suggesting potential for recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Voluntary driven exoskeleton as a new tool for rehabilitation in chronic spinal cord injury: a pilot study. Aach, M., Cruciger, O., Sczesny-Kaiser, M., et al.[2022]

Incorporating exoskeletal-assisted walking (EAW) into acute inpatient rehabilitation for spinal cord injury (SCI) significantly improved functional and motor recovery, with greater changes in Lower Extremity Motor Scores (LEMS) and Functional Independence Measure (FIM) scores compared to standard rehabilitation alone.

The study involved 30 participants (10 in the EAW group and 20 matched controls), and while one minor adverse event occurred during 42 EAW sessions, the intervention demonstrated a safe and effective way to enhance rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exoskeletal-Assisted Walking During Acute Inpatient Rehabilitation Leads to Motor and Functional Improvement in Persons With Spinal Cord Injury: A Pilot Study. Tsai, CY., Delgado, AD., Weinrauch, WJ., et al.[2020]

The Indego powered exoskeleton was found to be safe for use in 32 nonambulatory individuals with spinal cord injuries, with limited device-related adverse events and no interruptions in training over an 8-week period.

Participants showed significant improvements in walking speed and endurance in both indoor and outdoor conditions, as well as increased independence in donning and doffing the exoskeleton after the training program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Outcomes from a Multicenter Study Utilizing the Indego Powered Exoskeleton in Spinal Cord Injury. Tefertiller, C., Hays, K., Jones, J., et al.[2019]

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]

The ReWalk™ exoskeleton ambulation system was found to be safe and well-tolerated by six participants with spinal cord injuries, with no adverse events reported during an average of 13-14 training sessions.

Participants were able to walk 100 meters using the exoskeleton, and those with lower spinal cord injury levels demonstrated more efficient walking, indicating potential benefits for mobility in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerance of the ReWalk™ exoskeleton suit for ambulation by people with complete spinal cord injury: a pilot study. Zeilig, G., Weingarden, H., Zwecker, M., et al.[2022]

In a 4 to 5-week training program, all 7 nonambulatory individuals with thoracic and lumbar spinal cord injuries successfully learned to use a powered exoskeleton, achieving basic mobility skills such as standing, sitting, and walking indoors with assistance.

The training resulted in high user satisfaction and improved perceptions of quality of life, with only minor adverse events reported, indicating that the device-training was both effective and safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device-Training for Individuals with Thoracic and Lumbar Spinal Cord Injury Using a Powered Exoskeleton for Technically Assisted Mobility: Achievements and User Satisfaction. Platz, T., Gillner, A., Borgwaldt, N., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4809334/

Clinical effectiveness and safety of powered exoskeleton ... Powered exoskeletons allow patients with SCI to safely ambulate in real-world settings at a physical activity intensity conducive to prolonged use and known to ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02202538

Indego® Exoskeleton; Assessing Mobility for Persons With ... This study will evaluate the Indego® device for safety and effectiveness at allowing persons with SCI who are non-ambulatory or poorly ambulatory to stand up ...

3. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-021-00880-w

Exoskeleton-assisted walking improves pulmonary function ... Exoskeleton-assisted walking (EAW) is expected to improve the gait of spinal cord injury (SCI) individuals. However, few studies reported ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7534310/

Safety and feasibility of exoskeleton-assisted walking during ... Conclusion: Exoskeleton training in SCI-AIR can be safe and feasible for newly injured individuals with SCI who have clinically defined ambulatory goals.

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2823146

Exoskeletal-Assisted Walking in Veterans With Paralysis This randomized clinical trial examines whether the use of an exoskeletal-assisted walking device improves patient-reported mental and ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878875024001906

Exoskeleton-Assisted Rehabilitation and Neuroplasticity in ... Exoskeleton serves as an emerging and promising tool for rehabilitation, especially in promoting neuroplasticity and alleviating SCI-related complications.

7. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-022-01003-9

Overground robotic training effects on walking and secondary ... Overground powered lower limb exoskeletons (EXOs) have proven to be valid devices in gait rehabilitation in individuals with spinal cord injury (SCI).