Recruiting

TPAD

Sponsor:

Kessler Foundation

Code:

NCT06643312

Conditions

SCI - Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

The Tethered Pelvic Assist Device (TPAD)

Study Details

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

Conditions

SCI - Spinal Cord Injury

Study ID

NCT06643312

Start date

Oct 22, 2024

Status verified date

Dec, 2024

Completion date

Jan, 2028

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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

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

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

Interventions

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.

Primary outcome measure

  • Sitting Assessment [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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). ]

Central Contacts and Locations

Central contacts

Research Manager

9733243557LMartinez@KesslerFoundation.Org

Gail F Forrest, PhD

9733243518

Locations

Kessler Foundation

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

Research Manager

973-324-3557LMartinez@KesslerFoundation.Org

More Information

Sponsor

Kessler Foundation

Last update posted

Dec 16, 2024

Last verified

Dec, 2024

Keywords

  • TPAD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2024-12-16.