TPAD for Recovery of Standing After Severe SCI

Tethered Pelvic Assist Device 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 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

Study Overview

• Status: Recruiting
• Conditions: SCI - Spinal Cord Injury
• Intervention / Treatment: Device: The Tethered Pelvic Assist Device (TPAD)

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Research Manager; Phone Number: 9733243557; Email: LMartinez@KesslerFoundation.Org
• Study Contact Backup: Name: Gail F Forrest, PhD; Phone Number: 9733243518

Study Locations

• United States
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • Recruiting
      • Kessler Foundation
      • Contact: Research Manager; Phone Number: 973-324-3557; Email: LMartinez@KesslerFoundation.Org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Device: The Tethered Pelvic Assist Device (TPAD); 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.
Other: 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	Device: The Tethered Pelvic Assist Device (TPAD); 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.
No Intervention: Group 3; Individuals with SCI that can stand independently; Will undergo standing and posture assessments; Participation in this group will last about 2 weeks
No Intervention: Group 4; Individuals with SCI that cannot stand independently; Will undergo standing and posture assessments; Participation in this group will last about 2 weeks
No Intervention: Group 5; Individuals without a SCI; Will undergo standing, posture, and sitting assessments; Participation in this group will last about 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sitting Assessment	Research participants will sit on a padded table and perform tasks to challenge their balance control (reaching/shifting weight in multiple directions). Assistance for sitting will be provided at the trunk by the TPAD or by the trainer. EMG and kinematic analysis will be performed on the lower extremities, trunk and upper extremities during sitting. The trunk force and position controller data from the TPAD will be also collected; these data will be synchronized with EMG and kinematic data. Muscle activation patterns will be evaluated recording EMG from different muscle groups. The TPAD/trainer will then generate controlled loss of balance during sitting. EMG onset and burst duration relative to perturbation onset, loss of balance onset and return to balance will be compared. EMG mean and integrated amplitudes from each muscle will be compared before and after training. Relationships between these parameters will also be calculated and compared with non-disabled data.	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).
Neuromuscular Recovery Scale (NRS)	Research participants will undergo a series of tasks to test the level of muscle activation and amount of assistance required during standing and stepping in a body-weight supported treadmill environment, as well as overground motor tasks. Arm, trunk/leg movement recovery and independency will be measured by the NRS using 14 motor tasks (sit, reverse sit up, sit up, sitting truck extension, overhead press, forward reach and grasp, door pull and open, can open and manipulation, sit to stand, stand, walking, stand adaptability, step retraining, and step adaptability) and combined with EMG, kinematic, and kinetic analyses on the upper and lower extremities and/or trunk. Based on the performance across categories, 4 phase scores can be assigned:1- greatest impairment relative to normal movement patterns (non-ambulatory), 2- begins to stand and weight support independently, 3- walking with varying skill levels, and 4- normal locomotor and transfer performance with adaptability.	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).
Standing Assessment	Participants will stand as long as possible and undergo a series of standing tasks. Electromyography (EMG), kinematic and kinetic analysis will be performed on the lower extremities and trunk during standing. The pelvic, trunk and knee force and position controller data from the TPAD will be collected and synchronized. Muscle activation patterns will be evaluated recording EMG from different muscle groupings. When appropriate, ground reaction forces will be measured. Blood pressure and heart rate will be measured. The TPAD will then generate controlled loss of balance during standing. Participants will regain balance with/without grasping a fixed object. Investigators will compare EMG onset and burst duration relative to perturbation onset, loss of balance onset and return to balance if applicable. EMG mean and amplitudes from each muscle will be compared before and after training. The relationship between these parameters will also be calculated and compared with non-disabled data.	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).

Collaborators and Investigators

• Sponsor: Kessler Foundation
• Investigators: Principal Investigator: Gail F Forrest, Phd, Kessler Foundation

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: September 18, 2024
• First Submitted That Met QC Criteria: October 14, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: TPAD
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: R-1232-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All Individual Participant Data (IPD) will be kept with the study research team at Kessler Foundation. IPD will be de-identified and may be shared with the device research team at Columbia University, the FDA, Kessler Foundation Institutional Review Board, the Department of Health and Human Services, and collaborators at the Kentucky Spinal Cord Injury Research Center.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No