Improving balance for spinal cord injury patients using a robotic device and stimulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to explore how balance control is affected after spinal cord injury and to evaluate the effectiveness of a robotic assistive device called the Tethered Pelvic Assist Device (TPAD) in conjunction with spinal cord epidural stimulation. Participants will be divided into two groups to receive either TPAD training with stimulation or assessments without stimulation. The TPAD provides support and corrective forces to help improve muscle function and postural control during standing and sitting. A total of 20 spinal cord injured individuals with an implanted stimulation unit will be enrolled and assessed for their eligibility based on specific criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* At least 18 years old
* Stable medical condition.
* Has a spinal cord injury caused by trauma (fall, car accident, etc.) for at least one year that is not getting worse over time
* Has an implanted spinal cord epidural stimulation unit that is eligible for software upgrade as part of a previous study.
* Unable to stand independently with epidural stimulation turned off.

Exclusion Criteria:

* unwilling to discontinue from anti-spasticity medications
* Untreated painful problems with joints, muscles or bones.
* Unhealed fracture.
* Pressure sore or urinary tract infection.
* History of bone disease (except for decreased bone mineral density due to spinal cord injury).
* Ongoing drug abuse.
* Untreated psychiatric disorders or clinical depression.
* Received Botox injections in the lower extremities in the prior six months.
* Heart or lung disease that may interfere with assessments.
* Untreated severe and persistent problems regulating blood pressure, heart rate, body temperature or other automatic functions.

Where it's running

• Kessler Foundation
  West Orange, New Jersey, United States Recruiting

Study contacts

• Principal investigator: Principal Investigator — Kessler Foundation
• Study coordinator: Research Manager
• Email: LMartinez@KesslerFoundation.Org
• Phone: 9733243557

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• How different meals affect metabolism and heat production after high spinal cord injury

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  Recruiting University of Miami · Miami, Florida · NCT07103993

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.