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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is evaluating a new robotic device, the Tethered Pelvic Assist Device (TPAD), to determine if it can improve muscle function and balance in people with spinal cord injuries. The researchers aim to understand how balance is affected after a spinal cord injury and whether the TPAD, combined with spinal stimulation, can assist. Participants will be divided into two groups: one will use the TPAD for training and undergo assessments with and without stimulation, while the other will only have assessments. Suitable candidates have had a spinal cord injury for at least a year, cannot stand independently without stimulation, and have a special implant that can be updated. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance rehabilitation options for spinal cord injury patients.

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 prior data suggests that the Tethered Pelvic Assist Device (TPAD) is safe for spinal cord injury patients?

Research shows that the Tethered Pelvic Assist Device (TPAD) helps people with spinal cord injuries improve muscle function and balance. Studies have found that TPAD applies various forces to assist users in maintaining balance while standing or sitting. This robotic device supports the trunk, pelvis, and knees.

No detailed reports of serious side effects from using the TPAD exist. The device has been studied in other settings and is generally well-tolerated. Current research focuses on its effectiveness, with potential side effects being closely monitored. The trial phase is labeled "Not Applicable," indicating a focus on understanding the device's function rather than testing safety, as in other trials. This also suggests the treatment is considered safe enough to bypass early-phase safety trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for spinal cord injury, which often involves physical therapy and medications to manage symptoms, the Tethered Pelvic Assist Device (TPAD) offers a novel approach by integrating robotics and electrical stimulation. This device aids in retraining the body to stand and move through targeted stimulation combined with mechanical assistance. Researchers are particularly excited about TPAD because it could enhance motor recovery beyond what traditional therapies achieve, potentially improving quality of life for individuals with spinal cord injuries.

What evidence suggests that the Tethered Pelvic Assist Device is effective for improving muscle function after spinal cord injury?

Research has shown that the Tethered Pelvic Assist Device (TPAD) can help people with spinal cord injuries improve their ability to stand and sit with better balance. In this trial, participants in Group 1 will receive TPAD training sessions with spinal stimulation. Previous studies have found that this combination can help people walk more easily and respond better to balance challenges. Earlier research also discovered that the TPAD aids in maintaining balance while walking. Another study found that using TPAD training with spinal stimulation improved muscle function in people with spinal cord injuries. These findings suggest that TPAD could be a useful tool for enhancing balance and muscle control in these individuals. Participants in Group 2 will undergo assessments only, without the TPAD training sessions. ^{1 2 4 6 7}

Who Is on the Research Team?

Principal Investigator

Principal Investigator

Kessler Foundation

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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 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]

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]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06643312

TPAD for Recovery of Standing After Severe SCI

The purpose of this study is to investigate how standing and sitting balance control is altered after spinal cord injury (SCI) and how a new type of robotic ...

2.

nyp.org

nyp.org/publications/professional-advances/rehab/the-potential-of-robotics-making-strides-in-spinal-cord

The Potential of Robotics: Making Strides in Spinal Cord ...

Agrawal and his team have previously conducted studies that have shown that a single session of therapy with TPAD improved gait function and reactive reactions ...

3.

withpower.com

withpower.com/trial/phase-spinal-cord-injuries-9-2024-583f6

TPAD for Spinal Cord Injury

The purpose of this study is to investigate how standing and sitting balance control is altered after spinal cord injury (SCI) and how a new type of robotic ...

4.

nature.com

nature.com/articles/s41598-023-46145-5

Utilizing mobile robotics for pelvic perturbations to improve ...

Earlier work showcased improved gait stability and the first evidence of increased cognition acutely. The mobile Tethered Pelvic Assist Device ( ...

5.

me.columbia.edu

me.columbia.edu/news/new-5m-grant-support-robotics-research-spinal-cord-injury-patients

New $5M Grant to Support Robotics Research for Spinal ...

Their results show the effectiveness of stand training of SCI patients by combining epidural stimulation and principles of motor learning. The ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9611825/

The Outcomes of Robotic Rehabilitation Assisted Devices ...

This review aims at evaluating the impact of robotic-assisted rehabilitation in subjects who have suffered SCI, both in terms of regaining mobility as a major ...

7.

withpower.com

withpower.com/trial/phase-wounds-and-injuries-10-2024-f8f58

Robotic Stand Trainer for Spinal Cord Injury

This N/A medical study run by Kessler Foundation is evaluating whether The Tethered Pelvic Assist Device (TPAD) will have tolerable side effects & efficacy ...