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TPAD for Recovery of Standing After Severe SCI

NCT06643312 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-12-16

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Kessler Foundation

    lead OTHER

Principal Investigators

  • Gail F Forrest, PhD · Kessler Foundation

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-22
Primary Completion
2027-10-31
Completion
2028-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06643312 on ClinicalTrials.gov