Study Results
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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RECRUITING
NA
24 participants
INTERVENTIONAL
2025-03-01
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
\- Where multiple simultaneous appendices/interventions are evaluated the intent is to keep the independent assessor blinded to the intervention allocation.
RRULI: Appendix 1:
\- The outcome assessor will be independent of the providers of therapy.
Study Groups
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RRULI: Appendix 1
In this first arm of SCINC, adults with chronic tetraplegia will be assigned to the RRULI: Appendix 1 intervention.
Therapeutic Intermittent Hypoxia (TIH) + Exercise Training (ET)
TIH in combination with upper limb and respiratory ET. The intervention is predominantly home-based and will be delivered three times per week for six weeks.
Interventions
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Therapeutic Intermittent Hypoxia (TIH) + Exercise Training (ET)
TIH in combination with upper limb and respiratory ET. The intervention is predominantly home-based and will be delivered three times per week for six weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adults \> 18 years of age
* Able to independently ventilate
* Chronic SCI (\>1 years post-injury or impairment onset)
* Tetraplegia (C2-T1 level of injury)
* Evidence of motor incomplete paralysis in the upper limb below the neurological level of injury
* Have a documented management plan for their AD if it occurs.
Exclusion Criteria
* Pregnancy
* Medical instability, including current or recent (within the previous 6 weeks) infection or inflammation
* Current or recent (within the previous 6 weeks) pressure ulcers or cutaneous lesions
* Poorly controlled diabetes
* An episode of AD in the previous 6 months that required medical intervention to resolve
* Significant other neurological, psychiatric, pulmonary, cardiovascular, orthopaedic, or oncological conditions.
* Currently taking part in another clinical trial
* Upper limb contracture
18 Years
ALL
No
Sponsors
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Institute of Breathing and Sleep
UNKNOWN
Austin Health
OTHER_GOV
Neuroscience Research Australia
OTHER
The University of New South Wales
OTHER
University of Sydney
OTHER
University of Florida
OTHER
University of Melbourne
OTHER
Responsible Party
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Principal Investigators
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David Berlowitz, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Melbourne
Locations
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Austin Health
Heidelberg, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SCINC_MASTER
Identifier Type: -
Identifier Source: org_study_id
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