Robotic Stand Trainer for Spinal Cord Injury

Overseen By Research Manager

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Must not be taking: Anti-spasticity, Botox

Disqualifiers: Bone disease, Drug abuse, others

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: 40

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to understand how standing and sitting balance control is altered after spinal cord injury and how a new type of robotic assistive device may be used with spinal stimulation to improve muscle function. The investigators will be testing a device called the Tethered Pelvic Asist Device (or "TPAD") in this study. The TPAD may be helpful in two ways. It can be used to help control and support of the trunk, pelvis, and knees during stand training. Also, the TPAD can be used as a training tool by providing controlled "pushes" or "perturbations" that must be corrected by the person with spinal cord injury in order to maintain proper posture and upright balance. This could be helpful for improving muscle function after spinal cord injury. Participants will be placed into one of two groups based on availability and preference. Group 1 will receive TPAD training with stimulation and assessments with and without stimulation. Participation in this group lasts approximately 4 months. Group 2 will only receive assessments with and without stimulation. Participation in this group last approximately 3 weeks.

Will I have to stop taking my current medications?

If you are taking anti-spasticity medications, you will need to stop them to participate in this trial.

What data supports the effectiveness of the treatment Tethered Pelvic Assist Device (TPAD) for spinal cord injury?

Research on similar robotic devices, like exoskeletons, shows they can help improve bone density and bladder and bowel functions in people with spinal cord injuries. These devices also assist with balance and energy use during movements like standing up, which suggests that the TPAD might offer similar benefits. ^{1 2 3 4 5}

Is the Robotic Stand Trainer for Spinal Cord Injury safe for humans?

Research on standing devices for spinal cord injury shows that less than 10% of users experienced side effects like nausea or headaches, suggesting they are generally safe. Additionally, 79% of users recommended these devices, indicating a positive safety profile. ^{1 3 5 6 7}

How is the Tethered Pelvic Assist Device (TPAD) treatment different from other treatments for spinal cord injury?

The Tethered Pelvic Assist Device (TPAD) is unique because it is a passive device that uses elastic tethers to provide pelvic support and control during walking, which can be adjusted for different levels of assistance. Unlike other treatments, it offers a low-cost option for pelvic motion control and can be used alongside existing gait trainers to improve stability and balance. ^{5 8 9 10 11}

Research Team

Principal Investigator

Principal Investigator

Kessler Foundation

Eligibility Criteria

This trial is for individuals with spinal cord injuries who are interested in improving their balance. Participants should be able to commit to the study duration, which varies by group. Specific eligibility criteria details were not provided.

Inclusion Criteria

I can't stand on my own without epidural stimulation.

Has an implanted spinal cord epidural stimulation unit that is eligible for software upgrade as part of a previous study

My health condition is stable.

Exclusion Criteria

I have untreated painful issues with my joints, muscles, or bones.

Ongoing drug abuse

I do not have heart or lung disease that could affect my study assessments.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Training and Assessments

Group 1 receives TPAD training with stimulation and assessments with and without stimulation. Group 2 receives only assessments.

4 months for Group 1, 3 weeks for Group 2

40-60 training sessions and 5 assessments for Group 1; 4 assessments for Group 2

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• The Tethered Pelvic Assist Device (TPAD)

Trial Overview The study is testing the TPAD, a robotic device designed to assist with standing and sitting balance after spinal cord injury. It provides support and controlled perturbations for posture training. Group 1 will use the TPAD with stimulation over 4 months; Group 2 only gets assessments for about 3 weeks.

Participant Groups

Group I: Group 1- Training and Assessments Experimental Treatment 1 Intervention

10 SCI participants with an scES implant that will receive 40-60 TPAD training sessions with stimulation and 5 assessments with and without stimulation.

Group II: Group 2- Assessments Only Active Control 1 Intervention

10 SCI participants with an scES implant that will receive 4 assessments with and without stimulation.

The Tethered Pelvic Assist Device (TPAD) is already approved in United States for the following indications:

Approved in United States as Tethered Pelvic Assist Device for:

• Spinal Cord Injury Rehabilitation
• Standing and Sitting Balance Control Improvement

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

Findings from Research

Robotic exoskeletons, like the ReWalkTM P6.0, have shown beneficial effects in the rehabilitation of spinal cord injury patients by preventing complications associated with immobilization and improving overall health outcomes.

A multicenter clinical trial is being set up to investigate the effects of high-intensity exoskeleton-assisted rehabilitation on bone density and urogenital and gastrointestinal function, with the aim of establishing effective home-use protocols for these devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation of traumatic spinal cord injury with lower limb exoskeleton Tóth, L., Bors, V., Pallag, A., et al.[2020]

The use of a self-designed reciprocating gait orthosis (RGO) combined with rehabilitation training significantly improved bladder and bowel function in 12 paraplegic patients with complete spinal cord injuries over a 3-month period.

After RGO application, there was a notable reduction in urine bacteria, an increase in bladder volume and bowel pressure, and a decrease in residual bladder volume, indicating enhanced urinary health and overall quality of life for the patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Beneficial effects of reciprocating gait orthosis on bladder and bowel functions in paraplegia patients]. Sun, JL., Zhong, SZ., Ouyang, YT., et al.[2008]

In a study of 21 adults with tethered cord syndrome, common urinary symptoms included urgency and urge incontinence, with urodynamic evaluations revealing significant issues like hyperreflexia and detrusor-sphincter dyssynergia.

Post-surgery, only 29% of patients showed improvement in urodynamic findings, indicating that many patients may not experience significant benefits from surgical release, highlighting the need for ongoing monitoring and follow-up due to potential re-tethering.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urodynamic findings in adults with the tethered cord syndrome. Giddens, JL., Radomski, SB., Hirshberg, ED., et al.[2004]

A national survey of 99 spinal cord-injured individuals revealed that 84% were actively using standing devices, with most reporting minimal side effects (less than 10%) such as nausea or headaches.

Many users experienced benefits such as improved bladder emptying (21%), better bowel regularity, reduced urinary tract infections, and fewer bed sores, leading 79% of respondents to highly recommend these devices to others.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Follow-up assessment of standing mobility device users. Dunn, RB., Walter, JS., Lucero, Y., et al.[2022]

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]

The Walkbot robotic-assisted gait training (RAGT) system significantly improved hip and knee movement and reduced stiffness in individuals with paraplegia or quadriplegia after 8 weeks of training, involving an average of 43 sessions.

This study provides the first clinical evidence that Walkbot RAGT can enhance functional mobility and daily activities in patients who had previously plateaued in their recovery, indicating its potential as a valuable rehabilitation tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Walkbot gait training on kinematics, kinetics, and clinical gait function in paraplegia and quadriplegia. Hwang, J., Shin, Y., Park, JH., et al.[2019]

References

1. Hungary pubmed.ncbi.nlm.nih.gov

Rehabilitation of traumatic spinal cord injury with lower limb exoskeleton [2020]

2. China pubmed.ncbi.nlm.nih.gov

[Beneficial effects of reciprocating gait orthosis on bladder and bowel functions in paraplegia patients]. [2008]

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

Urodynamic findings in adults with the tethered cord syndrome. [2004]

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

Balance Control and Energetics of Powered Exoskeleton-Assisted Sit-to-Stand Movement in Individuals With Paraplegic Spinal Cord Injury. [2019]

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

Robotic upright stand trainer (RobUST) and postural control in individuals with spinal cord injury. [2023]

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

Follow-up assessment of standing mobility device users. [2022]

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

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

8. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of Walkbot gait training on kinematics, kinetics, and clinical gait function in paraplegia and quadriplegia. [2019]

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

Experimental studies on the human gait using a tethered pelvic assist device (T-PAD). [2012]

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

Utilizing Mobile Robotics for Pelvic Perturbations to Improve Balance and Cognitive Performance in Older Adults: A Randomized Controlled Trial. [2023]

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

Design and simulation of closed-loop electrical stimulation orthoses for restoration of quiet standing in paraplegia. [2019]