Investigating the effect of therapeutic acute intermittent hypoxia on upper limb and respiratory function in people more than one year post spinal cord injury: The AERO-SCI trial

Phase 2

Withdrawn

• Conditions: Spinal cord injury (chronic: > 1-year post impairment) with incomplete paralysis in target muscle groups; Neurological - Other neurological disorders

• Registration Number: ACTRN12622000648729
• Lead Sponsor: Austin Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-03
• Last Update Posted: 2 August 2023

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified