ACTRN12622000648729
Withdrawn
Phase 2
Assessing the effect of therapeutic acute intermittent hypoxia protocols on upper limb and respiratory function in people with chronic spinal cord injury: a Bayesian Optimal Phase II Design trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Austin Health
- Enrollment
- 40
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Young adults (aged 18 to 50 years)
- •\- Independently ventilating with a history of chronic SCI (\>1 year post\-injury or impairment onset. American Spinal Injury Association Impairment Scale \[ASIA] A to D; with incomplete paralysis in target muscle groups)
- •\- Able to perform one block on the Box and Block Test
- •\- Medically stable
- •\- Ability to follow verbal and visual commands
- •\- Ability to provide informed consent
Exclusion Criteria
- •\- Medically unstable, including current or recent infection or inflammation
- •\- Current or recent (within the previous 6 weeks) pressure ulcers or cutaneous lesions
- •\- Poorly controlled diabetes
- •\- An episode of autonomic dysreflexia in the previous 6 months
- •\- Significant other neurological, psychiatric, pulmonary, cardiovascular, orthopedic (including osteoporosis and/or previous post\-SCI fracture) or oncological conditions
- •\- Severe untreated obstructive sleep apnoea
- •\- Recent change in medication prescription
- •\- Not proficient in English
- •\- Pregnancy
Outcomes
Primary Outcomes
Not specified
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