Spinal Cord Injury > TPAD

TPAD for Spinal Cord Injury

Recruiting in Palo Alto (17 mi)

Overseen By Gail F Forrest, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Kessler Foundation

No Placebo Group

Approved in 1 jurisdiction

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

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.

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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.

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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.

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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.

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 am 18 years old or older.

My spinal cord injury is above T10 and is not getting worse.

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

My injury is classified from mild to severe.

It has been over a year since my spinal cord injury.

I cannot stand up on my own.

Exclusion Criteria

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

I have a neurological injury or disease.

I have an injury or condition related to my bones or muscles.

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

I do not want to stop taking my anti-spasticity medications.

I have untreated painful conditions like muscle issues, broken bones, or infections.

I have heart or lung conditions that could affect health evaluations.

I have not been treated for psychiatric disorders or clinical depression.

Participant Groups

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.

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

Find A Clinic Near You

Research locations nearby Select from list below to view details:

Kessler Foundation West Orange, NJ

Who is running the clinical trial?

Kessler Foundation Lead Sponsor

References

1. Italy pubmed.ncbi.nlm.nih.gov

[A rare cause of occult neuropathic bladder in children: the tethered cord syndrome]. [2016] The tethered cord syndrome is a form of spinal dysraphism in which a short, thickened filum terminale prevents the ascent of the conus medullaris and intraspinal lipoma causes compression upon the caudal part of the spinal cord. In pediatric age the first symptoms are urological: urinary incontinence and infection. Diagnosis is performed with urodynamic studies followed by nuclear magnetic resonance. Tethered cord syndrome is no obvious cause of a neurogenic bladder. When this pathological conditions is recognized properly and an operation is performed early the likelihood of improvement is rather high. The authors report a case of tethered cord syndrome in a girl seven years old.

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

Urodynamic findings in adults with the tethered cord syndrome. [2004] We evaluated bladder function in adults with the tethered cord syndrome using multichannel urodynamics.

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

Follow-up assessment of standing mobility device users. [2022] The use of standing devices by spinal cord-injured subjects was investigated through a national survey of a sample of individuals who returned their manufacturer's warranty card to two companies. We obtained a 32% response rate (99/310). The majority of respondents were male (87%) with a median age between 41 and 50 years. Seventy-seven percent were paraplegic and 21% were quadriplegic. Forty percent had between 1 and 5 years experience with their device, and 84% of those responding were currently using their standing device. Forty-one percent used their standing device one to six times a week; two-thirds stood between 30 minutes and 1 hour for each use. Less than 10% of subjects experienced any side effects, such as nausea or headaches, from standing. Twenty-one percent of subjects reported being able to empty their bladder more completely. There was also a favorable response by some individuals on the effects of the standing devices on bowel regularity, reduction of urinary tract infections, leg spasticity, and number of bed sores. Finally, 79% of subjects highly recommended use of standing devices to other people with spinal cord injury. The positive responses of individuals using standing devices is a strong recommendation for the assistive technology community to make these devices more available to individuals with spinal cord injury.

4. England pubmed.ncbi.nlm.nih.gov

Analysis of assisted-gait characteristics in persons with incomplete spinal cord injury. [2022] Ambulatory assistive device use can improve functional independence following spinal cord injury and, potentially, quality of life. However, the interaction between aids and user in this population is poorly understood.

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

Urodynamic findings in children with myelomeningocele after untethering of the spinal cord. [2007] The effect on bladder function of tethered spinal cord release in individuals with myelomeningocele differs in published studies, and the benefit has been the subject of debate. We studied the urodynamic findings in a consecutively treated population.

6. China pubmed.ncbi.nlm.nih.gov

[Beneficial effects of reciprocating gait orthosis on bladder and bowel functions in paraplegia patients]. [2008] To evaluate the beneficial effects of application of a self-designed reciprocating gait orthosis (RGO) combined with comprehensive rehabilitation training on bladder and bowel function in paraplegic patients sustaining spinal cord injuries (SCI).

7. 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] Many persons with spinal cord injury (SCI) require an ambulatory assistive device (AAD). An effective monitoring method enables the use of an appropriate AAD and promotes levels of independence for patients. This study investigated the discriminative ability of the three-functional tools relating to walking ability, including the 10-meter walk test (10MWT), the five times sit-to-stand test (FTSST), and the timed up and go test (TUGT), in independent ambulatory persons with SCI who walked with walker, crutches, cane, and non-AAD.

8. Hungary pubmed.ncbi.nlm.nih.gov

Rehabilitation of traumatic spinal cord injury with lower limb exoskeleton [2020] In recent years, several technological innovations have emerged to improve the rehabilitation of traumatic spinal cord injury (SCI). Among them, robotic orthosis, also known as human exoskeletons, are prominent devices for lower limb therapy. Since the early 2000s, numerous clinical studies have begun to investigate the efficacy of these devices, demonstrating the beneficial effects of exoskeletons regarding the prevention and deceleration of the progression of complications following spinal cord injury and subsequent immobilization. Previous works also deal with physiological, psycho-social and social effects, and presents possible risk factors following SCI. In this paper, the main results of the relevant international research is reviewed, the structure and operation of the first devices (ReWalkTM P6.0) in Hungary are presented, also, the main modalities of robotic assisted rehabilitation activity at international level are demonstrated. Based on the international results, the training protocol for a multicentre controlled clinical trial, involving the University of Pécs and the National Institute for Medical Rehabilitation is presented in this work. According to our hypothesis, high intensity exoskeleton-assisted complex rehabilitation induces positive changes in bone density, in the urogenital and gastrointestinal tract. Changes are quantified by objective urodynamic and defecative parameters. The difference in bone density is assessed with DEXA scan, and the effects on mental status are evaluated by questionnaires. The aim of this research is to promote a complementary therapeutic procedure based on validated results for SCI patients with paraplegia, also to establish recommendations for home use of the robotic exoskeletons, and to conceivably join to international scientific research projects. Orv Hetil. 2020; 161(29): 1200-1207.

9. 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] To evaluate the effect of homogeneous spinal-shortening axial decompression procedure (HSAD) on bladder function in patients with spina bifida tethered syndrome.