TPAD for Spinal Cord Injury

Overseen By Gail F Forrest, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Must not be taking: Anti-spasticity, Botox

Disqualifiers: Drug abuse, Psychiatric disorders, Cardiopulmonary, 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: Unknown

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a new robotic device, the Tethered Pelvic Assist Device (TPAD), can improve muscle function and balance in people with spinal cord injuries (SCI). The main focus is on how SCI affects standing and sitting balance and whether this device can aid in posture control. Participants will be grouped based on their ability to stand independently, with some receiving TPAD training and others undergoing assessments. The trial seeks individuals who have lived with a stable spinal cord injury for over a year and can either stand for short periods or cannot stand independently.

As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance the quality of life for those with SCI.

Will I have to stop taking my current medications?

You may need to stop taking anti-spasticity medications, as the trial requires participants to be willing to wean off them.

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

Earlier studies have shown that the Tethered Pelvic Assist Device (TPAD) can help people with spinal cord injuries improve balance and movement. Research indicates that it safely applies gentle pressure to the pelvis to assist with standing and sitting. Most users have tolerated TPAD well, with few reports of discomfort.

In trials, the device helped participants regain movement without causing major side effects. This suggests that TPAD is a safe option for many individuals with spinal cord injuries seeking to improve their ability to stand and sit. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Tethered Pelvic Assist Device (TPAD) for spinal cord injury (SCI) because it offers a unique approach to rehabilitation. Unlike standard therapies that might focus on strength training or physical therapy alone, the TPAD provides dynamic support to help individuals with SCI engage in functional movements like standing, sitting, and stepping. This device could lead to more effective retraining of posture and movement patterns by simulating real-world conditions, potentially accelerating recovery and improving quality of life for patients with SCI.

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

This trial will evaluate the Tethered Pelvic Assist Device (TPAD) for individuals with spinal cord injuries. Studies have shown that TPAD can improve balance and muscle function. Research indicates that even one session with TPAD can enhance walking and improve quick movements the body makes to stay balanced. Earlier work with TPAD demonstrated better stability and increased brain function immediately after use. These findings suggest TPAD could be a promising tool for helping people with spinal cord injuries regain better control over standing and sitting. Participants in this trial will be divided into different groups, with some receiving TPAD training and others undergoing assessments without the device. ^{1 2 4 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 individuals with spinal cord injury (SCI). Group 1 and 3 include those who can stand independently, while Group 2 and 4 are for those who cannot. Group 5 is for individuals without SCI. Participants will undergo various assessments related to standing, posture, sitting, and stepping over periods ranging from two weeks to six months.

Inclusion Criteria

I can stand on my own for up to an hour.

I cannot stand up on my own.

My health condition is stable.

Exclusion Criteria

Ongoing drug abuse

I have severe and ongoing issues with my autonomic nervous system.

I have received botox injections in my legs within the last six months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

TPAD Training and Assessment

Participants receive TPAD training and undergo standing, posture, sitting, and stepping assessments

6 months

Multiple visits for training and assessments

Assessment Only

Participants undergo standing, posture, and sitting assessments without TPAD training

2 weeks

Multiple visits for assessments

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 tests the Tethered Pelvic Assist Device (TPAD) in improving muscle function and balance control during standing and sitting in people with SCI. It aims to examine muscle activation patterns with robotic assistance or self-assistance during these activities.

How Is the Trial Designed?

Group I: Group 2 Experimental Treatment 1 Intervention

* Individuals with SCI that cannot stand independently * Will receive TPAD training * Will undergo standing, posture, sitting, and stepping assessments * Participation in this group will last about 6 months

Group II: Group 1 Experimental Treatment 1 Intervention

* Individuals with SCI that can stand independently * Will receive TPAD training * Will undergo standing, posture, sitting, and stepping assessments * Participation in this group will last about six months

Group III: Group 3 Active Control 1 Intervention

* Individuals with SCI that can stand independently * Will undergo standing and posture assessments * Participation in this group will last about 2 weeks

Group IV: Group 4 Active Control 1 Intervention

* Individuals with SCI that cannot stand independently * Will undergo standing and posture assessments * Participation in this group will last about 2 weeks

Group V: Group 5 Active Control 1 Intervention

* Individuals without a SCI * Will undergo standing, posture, and sitting assessments * Participation in this group will last about 2 weeks

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

Published Research Related to This Trial

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]

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 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]

The homogeneous spinal-shortening axial decompression procedure (HSAD) significantly improved bladder function in 24 patients with spina bifida tethered syndrome, with all urodynamic evaluations showing dramatic improvements (P < 0.01).

Postoperative evaluations indicated that 25% of patients reported a return to normal bladder function subjectively, while only 4.2% experienced deterioration, highlighting HSAD's potential as an effective treatment for long-term urinary incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urodynamic evaluation of bladder function in patients with urinary incontinence secondary to congenital tethered cord syndrome after homogeneous spinal-shortening axial decompression procedure. Xu, X., Sun, K., Sun, J., et al.[2022]

In a study involving ten individuals with incomplete spinal cord injury, walkers provided the most vertical support (up to 100% of body weight) but resulted in slower walking speeds and a forward flexed posture.

Elbow crutches allowed for faster walking with greater step length and a more upright posture, while canes offered the least vertical support but provided some lateral stability and propulsive assistance, highlighting the need for rehabilitation specialists to tailor device selection to individual user needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of assisted-gait characteristics in persons with incomplete spinal cord injury. Melis, EH., Torres-Moreno, R., Barbeau, H., et al.[2022]

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 assessed 85 individuals with spinal cord injury (SCI) and found that those not using ambulatory assistive devices (AADs) performed significantly better on walking ability tests compared to those using AADs, indicating the effectiveness of these tests in measuring functional ability.

The results suggest that the five times sit-to-stand test (FTSST) could serve as a simple screening tool to evaluate walking advancement in individuals using walkers, although further research is needed to confirm this potential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discriminative ability of the three functional tests in independent ambulatory patients with spinal cord injury who walked with and without ambulatory assistive devices. Saensook, W., Poncumhak, P., Saengsuwan, J., et al.[2022]

In a study of 20 children with myelomeningocele who underwent tethered spinal cord release, 35% showed improvement in bladder function after surgery, while only 5% experienced deterioration.

All patients who had worsening bladder function before surgery improved after the procedure, and 90% of those with stable bladder function before surgery remained stable afterward, highlighting the importance of regular bladder evaluations in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urodynamic findings in children with myelomeningocele after untethering of the spinal cord. Abrahamsson, K., Olsson, I., Sillén, U.[2007]

Tethered cord syndrome, characterized by a short, thickened filum terminale and intraspinal lipoma, can lead to significant urological symptoms like urinary incontinence and infections in children.

Early diagnosis through urodynamic studies and MRI, followed by timely surgical intervention, greatly increases the chances of improvement in symptoms for affected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A rare cause of occult neuropathic bladder in children: the tethered cord syndrome]. Campobasso, P., Galiani, E., Verzerio, A., et al.[2016]

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 ...