Clinical trial NCT06643312: TPAD for Recovery of Standing After Severe SCI
Official title: Tethered Pelvic Assist Device for Recovery of Standing After Severe SCI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: SCI - Spinal Cord Injury
Keywords: TPAD
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will include 50 participants, 20 with SCI who are able to stand independently for short periods of time (\<1 hour) (Groups 1 \& 3), 20 participants with SCI who are unable to stand independently (Groups 2 \& 4), and 10 non-disabled individuals (Group 5). Group 1 (n=10) will be evaluated before and after receiving stand training with the TPAD. Group 2 (n=10) will be evaluated before and after receiving stand training with the TPAD. Group 3 (n=10) will be evaluated without receiving any intervention. Group 4 (n=10) will be evaluated without receiving any intervention. Groups 3 and 4, who will not receive any intervention, will undergo the Stable Standing Assessment and the Postural Perturbation Assessment only. Group 5 (n=10) will undergo assessments only. Each individual will serve as their own control, reducing the variability among individuals. Motor patterns recorded from the SCI participants will be also compared to those collected from non-disabled individuals.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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

Detailed description: The investigators will be testing a device called the Tethered Pelvic Assist Device or TPAD. The TPAD provides active control and support of the trunk, pelvis, and knees during training to improve the ability to stand. Also, the TPAD can be used to safely challenge participants during standing by providing controlled "pushes" or "perturbations" that must be corrected for in order to maintain proper posture and upright balance. This could be helpful for improving muscle function after spinal cord injury.

Methodology:

The Tethered Pelvic Assist Device (TPAD) is a light-weight cable-driven robotic stand trainer that (i) can provide assistance-as-needed by applying corrective forces on the trunk and pelvis in response to their movement outside a pre-programmed area, and (ii) can apply controlled forces on the trunk and pelvis to perturb them from their nominal configuration during standing.

A total of 50 participants will be enrolled in this study; they will be broken into five groups with 10 participants in each. All participants will undergo a physical classification of their spinal cord injury to determine eligibility and which group they belong in. Group 1 will consist of individuals with SCI that can stand independently and will receive TPAD training and assessments, Group 2 will consist of individuals with SCI that cannot stand independently and will receive TPAD training and assessments, Group 3 will consist of individuals with SCI that can stand independently and will receive assessments only, Group 4 will consist of individuals with SCI that cannot stand independently and will receive assessments only, and Group 5 will consist of individuals without a SCI that will receive assessments only. Each individual will serve as their own control, to reduce variability. Motor patterns recorded from the SCI research participants will be also compared to those collected from individuals who do not have a SCI. All participants will undergo the Stable Standing Assessment and Postural Perturbation Assessment. Groups 1, 2, and 5 will additionally perform the Stable Sitting Assessment and Postural Perturbation Assessment in Sitting. Only Groups 1 and 2 will also perform the Neuromuscular Recovery Scale and attend training sessions with the TPAD system.

Eligibility criteria: Inclusion Criteria:

1. At least 18 years of age at the time of enrollment;
2. stable medical condition
3. at least one year post-spinal cord injury (Groups 1-4)
4. non-progressive, traumatic SCI above T10 (Groups 1-4)
5. Injury Grade A, B, C or D (Groups 1-4)
6. ability to stand independently for short periods of time, not exceeding 1 hour (Groups 1 and 3)
7. inability to stand independently (Groups 2 and 4)

Exclusion Criteria:

1. unwillingness to wean from anti-spasticity medications;
2. untreated painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore or urinary tract infection
3. history of bone disease unassociated with decreased bone mineral density due to spinal cord injury
4. ongoing drug abuse
5. untreated psychiatric disorders or clinical depression
6. received botox injections in lower extremities in the prior six months
7. Cardiopulmonary disease that may interfere with assessments
8. Untreated severe and persistent dysautonomia
9. Neurological injury or disease (Group 5)
10. Orthopedic injury or condition (Group 5)

Primary outcomes:
measure: Sitting Assessment
timeFrame: On average 4 hours to complete. Done at the beginning of the study for groups 1, 2, and 5. Repeated by groups 1 & 2 during training (up to 4 times) and at the end of the study (on average 6 months).
measure: Neuromuscular Recovery Scale (NRS)
timeFrame: On average, 2 hours to complete. Groups 1 and 2 will complete the NRS at the beginning of the study and at the end (on average 6 months).
measure: Standing Assessment
timeFrame: On average 4 hours to complete. Done at the beginning of the study for all groups. Repeated by groups 1 & 2 during training (up to 4 times) and at the end of the study (on average 6 months).
Secondary outcomes:
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Gail F Forrest, PhD
role: PRINCIPAL_INVESTIGATOR
References: