Orthostatic, Respiratory, Balance-Intervention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-13

Study Completion Date

2020-07-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IMT Intervention

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.

Group Type EXPERIMENTAL

Inspiratory Muscle Training (IMT)

Intervention Type OTHER

IMT is a breathing training technique customized to participant's breathing capacity. Using a handheld electronic manometer (Pro2Fit from Smithfield), a study personnel will initiate training at 40-60% maximal inspiratory pressure. Adjustments will be customized to where the participant reports a difficulty of training between 4-6 out of 10. Training sessions will be performed about 30 minutes a day for 28 consecutive days.

Interventions

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Inspiratory Muscle Training (IMT)

IMT is a breathing training technique customized to participant's breathing capacity. Using a handheld electronic manometer (Pro2Fit from Smithfield), a study personnel will initiate training at 40-60% maximal inspiratory pressure. Adjustments will be customized to where the participant reports a difficulty of training between 4-6 out of 10. Training sessions will be performed about 30 minutes a day for 28 consecutive days.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No