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TPAD for Recovery of Standing After Severe SCI

Kessler Foundation · NCT06643312

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
50
US sites recruiting
1
Study start
October 22, 2024
Record last updated
December 16, 2024

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

  • 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

Being studied: The Tethered Pelvic Assist Device (TPAD)

Conditions: SCI - Spinal Cord Injury

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

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

Exclusion Criteria

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

Recruiting US locations

  • Kessler Foundation

    West Orange, NJ 07052

    Site contact: Research Manager · 973-324-3557 · LMartinez@KesslerFoundation.Org

Study contacts (from the official record)

  • Research Manager · 9733243557 · LMartinez@KesslerFoundation.Org
  • Gail F Forrest, PhD · 9733243518
All healthy volunteers studies in New Jersey →
TPAD for Recovery of Standing After Severe SCI (NCT06643312) | Bored Studies