Orthostatic, Respiratory, Balance-Intervention

Completed · Not applicable

Conditions studied: Spinal Cord Injuries

In brief

The purpose of this study is to help understand how training breathing muscles will impact balance, blood pressure, and quality of life of participants with spinal cord injury.

Key facts

Study ID

NCT04210063

Run by

University of Miami

People needed

18

Starts

2019-12-13

Expected to finish

2020-07-29

Last updated by the study team

2020-08-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Upper/lower/both extremity weakness or paralysis resulting from SCI with ASIA Impairment Scale (AIS) grades A-C who use a wheelchair as primary means of mobility.
• ≥1 year post-injury
• Willingness to participate in the study and provide consent.

You may not qualify if…

• Inability to understand the consent form or consent process
• Reliance on a mechanical ventilator.
• Use of Betablockers
• Inability to travel to The Miami Project for weekly sessions during intervention month
• Any complication that would limit transfer ability, or compromise supine or sitting tolerance, including but not limited to:
• Fracture, dislocation, or malformations affecting supine or sitting tolerance.
• Spinal instability.
• Pressure ulcers or skin integrity issues on contact surfaces that would prohibit sitting or lying in supine.
• Individuals who are able to stand independently or with a walker
• Unresolved deep vein thrombosis (DVT).
• Hospitalization due to autonomic dysreflexia in the last 3 months.
• Pregnancy determined by urine testing in sexually active females.

Where it is running

• The Miami Project to Cure Paralysis — Miami, Florida, United States

Full record on ClinicalTrials.gov

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