Therapeutic Intermittent Hypoxia (TIH) + Exercise Training (ET)
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.
Study summary
SCINC is an adaptive design Master protocol that seeks to determine if there is "sufficient promise" of beneficial effect of treatment combinations to enhance motor recovery in pre-specified strata of people with a spinal cord injury.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
SCINC Inclusion Criteria:
\- Person with SCI
SCINC Exclusion Criteria:
\- Proven contraindication to intervention
RRULI: Appendix 1 (TIH + ET) study-specific 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.
RRULI: Appendix 1 (TIH + ET) study-specific 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
Primary outcome measure(s)
At an individual participant level, the Phase IIA study has a single, binary, composite primary outcome to determine if there is a 'signal of benefit', measuring effectiveness, no deterioration, safety and acceptability. — Baseline and 6-weeks. The single binary outcome includes the following components:
A) Effectiveness - Increase above baseline that is equal or more than the predefined outcome-specific stated thresholds, on at least ONE of the: Action Reach Arm Test (ARAT), Handheld dynamometer (GRIP) Maximal inspiratory pressure (MIP) B) No deterioration - No deterioration below baseline. C) Safety - Incidence of Autonomic Dysreflexia (AD) episodes occurring during the intervention period for each individual participant.
D) Acceptability - Rate of participant adherence to intervention sessions. Please refer to the following primary outcomes for details of each of these components.
A) Effectiveness: Increase above baseline that is equal or more than the predefined outcome-specific stated thresholds, on at least ONE of the: Action Reach Arm Test (ARAT), Handheld dynamometer (GRIP) Maximal inspiratory pressure (MIP) — Baseline and 6 week follow-up ARAT: Assesses grasp, grip, pinch and gross movement. A minimal clinically important difference of 5.7 points is accepted in SCI.
GRIP: Grip strength will be measured according to a standardised procedure. A threshold of 5.0 kg will be used.
MIP: Respiratory muscle strength will be measured according to standard procedures. A threshold of 10cmH20 will be used.
B) No deterioration — Baseline and 6 week follow-up No deterioration (decline below baseline) that is equal or more than the predefined outcome-specific stated threshold, on ANY of the ARAT, GRIP and MIP.
C) Safety - Incidence of Autonomic Dysreflexia (AD) episodes occurring during the intervention period for each individual participant. — Up to 6 weeks. Fewer than two AD events that fail to resolve with participants usual, community interventions.
D) Acceptability - Rate of participant adherence to the intervention, as assessed by monitoring attendance to treatment sessions.. — Up to 6 weeks. Adherence with at least 70% of treatment sessions.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
