TPAD for Recovery of Standing After Severe SCI

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKessler Foundation

About 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

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • The Tethered Pelvic Assist Device (TPAD)

Treatment groups

50 Participants
are divided into 5 treatment groups

Sponsors and collaborators