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

Trial Summary

What is the purpose of this trial?

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 assistive device may be used to improve muscle function. This device is called the Tethered Pelvic Assist Device, or TPAD. The main aims are to: 1. Examine muscle activation patterns generated during different types of standing in spinal cord injured individuals using robotic assistance or self-assistance for balance 2 and 3. Examine the effectiveness of robotic-assisted stand training in the improvement of posture control during different types of standing and sitting in spinal cord injured individuals. Participants will be placed into one of 5 groups based on a physical classification of their spinal cord injury: Group 1: * 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 2: * 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 3: * Individuals with SCI that can stand independently * Will undergo standing and posture assessments * Participation in this group will last about 2 weeks Group 4: * Individuals with SCI that cannot stand independently * Will undergo standing and posture assessments * Participation in this group will last about 2 weeks Group 5: * Individuals without a SCI * Will undergo standing, posture, and sitting assessments * Participation in this group will last about 2 weeks

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 data supports the effectiveness of the treatment TPAD for Spinal Cord Injury?

Research on standing devices, which are similar to TPAD, shows that they can help people with spinal cord injuries improve bladder function, bowel regularity, and reduce urinary tract infections. Many users of these devices report positive outcomes and recommend them to others with similar conditions. ^{1 2 3 4 5}

Is the Tethered Pelvic Assist Device (TPAD) safe for humans?

There is no specific safety data available for the Tethered Pelvic Assist Device (TPAD) in the provided research articles. ^{1 3 4 6 7}

How does the TPAD treatment for spinal cord injury differ from other treatments?

The TPAD treatment for spinal cord injury is unique because it may involve a novel approach or technology not covered in the existing research, such as robotic exoskeletons or standing devices, which focus on rehabilitation and improving mobility. These devices have shown benefits in bone density, urogenital and gastrointestinal health, and overall quality of life for patients with spinal cord injuries. ^{1 4 7 8 9}

Research Team

Gail F Forrest, PhD

Principal Investigator

Kessler Foundation

Eligibility Criteria

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.

My health condition is stable.

I cannot stand up on my own.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

References

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

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

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

Urodynamic findings in children with myelomeningocele after untethering of the spinal cord. [2007]

3. China pubmed.ncbi.nlm.nih.gov

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

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

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

5. Germany 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Analysis of assisted-gait characteristics in persons with incomplete spinal cord injury. [2022]

7. Hungary pubmed.ncbi.nlm.nih.gov

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

8. Italy pubmed.ncbi.nlm.nih.gov

[A rare cause of occult neuropathic bladder in children: the tethered cord syndrome]. [2016]

9. England 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. [2022]