Spinal Cord Injuries
Conditions
Brief 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.
Detailed description
SCINC utilises an adaptive design with interim analyses to assess whether a given intervention is futile or shows a signal of benefit within an appendix-specific study. The SCINC Master Protocol describes trial procedures, data collection, data monitoring, follow-up visits, and safety procedures that will be employed in all study-specific Appendices. The study-specific Appendix is a Bayesian optimised phase IIA trial, operating under the overarching SCINC Master Protocol. The first study-specific appendix is: Restoration of Respiratory and Upper Limb function after cervical spinal cord Injury (RRULI): Therapeutic Intermittent Hypoxia (TIH) + Exercise Training (ET). The RULLI: Appendix 1 (TIH + ET) aims to determine if ET plus TIH in people with chronic tetraplegia is a therapy with sufficient promise to test in a Phase IIb/III trial; considering feasibility, safety and efficacy. As new interventions are put forth, they will be added to the Master Protocol as a new Appendix. This Master Protocol describes trial procedures, data collection, data monitoring, follow-up visits, and safety procedures that will be employed in all study-specific Appendices. Each study-specific Appendix will have a process evaluation protocol.
Interventions
OTHERTherapeutic 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.
Sponsors
Institute of Breathing and Sleep
Austin Health
Neuroscience Research Australia
The University of New South Wales
University of Sydney
University of Florida
University of Melbourne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
SCINC Master protocol: \- 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.
Intervention model description
Adaptive design Master Protocol investigating multiple interventions within multiple study-specific Appendices.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived work of breathing | Baseline and 6-weeks. | Modified Borg dyspnoea scale. A scale from 0 (no difficulty breathing) - 10 (very, very severe) - where a higher score is a worse outcome. |
| Respiratory function will assessed using spirometry. | Baseline and 6-weeks. | Respiratory function measurement - physiological. Spirometry is a test of lung function and can measure how much air a person can force out of their lungs in 1 second (FEV1), and in total (forced vital capacity, FVC). |
| Maximal expiratory pressure (MEP) and sniff nasal inspiratory pressure (SNIP) | Baseline and 6-weeks | Respiratory muscle strength |
| Peak cough flow (L/min) | Baseline and 6-weeks | Cough effectiveness |
| Minute Ventilation (Litres) | Baseline and 6-weeks. | Ventilation response measurement - physiological. |
| 9-hole Peg test | Baseline and 6-weeks. | A test of upper limb dexterity and function. This test will be undertaken using the dominant hand. |
| Respiratory Rate measured in breaths per minute. | Baseline and 6-weeks. | Ventilation response measurement - physiological. |
| Tidal volume, measured in litres. | Baseline and 6-weeks. | Ventilation response measurement - physiological measure. |
| Ventilation response - assessing mouth pressure (measured in cmH20) | Baseline and 6-weeks. | Ventilation response measure - physiological. |
| Inspiratory time, measured in seconds (s). | Baseline and 6-weeks. | Ventilation response measurement - physiological. |
| Inspiratory and expiratory flow, measured in Litres per second (L/s). | Baseline and 6-weeks. | Ventilation response measurement - physiological. |
| End of tidal breathing oxygen and carbon dioxide saturation. | Baseline and 6-weeks. | Ventilation response measurement - physiological. |
| Pinch grip dynamometer | Baseline and 6-weeks. | Pinch strength |
| Penn Spasm Frequency Scale | Baseline and 6-weeks. | Self-report measure of upper limb spasticity composed of 2-parts: 1. Spasm frequency: scale 0 (no spasm) - 4 (spasms occurring more than 10 times per hour). 2. Spasm severity: scale 1 (mild) - 3 (severe). A higher score indicates a worse outcome for both components of the scale. |
| Capabilities of upper extremity questionnaire | Baseline and 6 weeks | Questionnaire assessing upper limb function. Scored on a 7-point scale representing self-perceived difficulty: 1= totally limited, can't do at all 7= not at all limited Minimum score = 32 Maximum score = 224 (higher score = greater function) |
| Sleep quality and Obstructive Sleep Apnoea (OSA) will be assessed using polysomnography (a sleep study) | 1 day | In the week prior to the intervention period, a home-based overnight polysomnography test will occur in the participants home to assess for OSA. |
Countries
Australia
Contacts
Primary ContactLaura Stendell
Backup ContactNicole Sheers, PhD
Outcome results
None listed