Orthostatic, Respiratory, Balance-Intervention (ORB-I)

University of Miami

Status: Completed

Conditions: Spinal Cord Injuries

Treatments: Other: Inspiratory Muscle Training (IMT)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04210063

20190838

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. ≥1 year post-injury
3. Willingness to participate in the study and provide consent.

Exclusion criteria

1. Inability to understand the consent form or consent process

2. Reliance on a mechanical ventilator.

3. Use of Betablockers

4. Inability to travel to The Miami Project for weekly sessions during intervention month

5. 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.

6. Individuals who are able to stand independently or with a walker

7. Unresolved deep vein thrombosis (DVT).

8. Hospitalization due to autonomic dysreflexia in the last 3 months.

9. Pregnancy determined by urine testing in sexually active females.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

IMT Intervention

Experimental group

Description:

During the first month, participants will be in a month-long control wash in period where no intervention will be provided. During the second month, participants will be in a 4-week daily IMT intervention period. During the third month, participants will be in a month-long efficacy period with no intervention provided.

Treatment:

Other: Inspiratory Muscle Training (IMT)