Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Institute of Breathing and Sleep | UNKNOWN |
| Austin Health | OTHER_GOV |
| Neuroscience Research Australia | OTHER |
| The University of New South Wales |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RRULI: Appendix 1 | Experimental | In this first arm of SCINC, adults with chronic tetraplegia will be assigned to the RRULI: Appendix 1 intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic Intermittent Hypoxia (TIH) + Exercise Training (ET) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline and 6-weeks. |
| 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) | 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. | Baseline and 6 week follow-up |
| B) No deterioration | 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. | Baseline and 6 week follow-up |
| C) Safety - Incidence of Autonomic Dysreflexia (AD) episodes occurring during the intervention period for each individual participant. | Fewer than two AD events that fail to resolve with participants usual, community interventions. |
| Measure | Description | Time Frame |
|---|---|---|
| 9-hole Peg test | A test of upper limb dexterity and function. This test will be undertaken using the dominant hand. | Baseline and 6-weeks. |
| Pinch grip dynamometer | Pinch strength |
Not provided
SCINC Inclusion Criteria:
- Person with SCI
SCINC Exclusion Criteria:
- Proven contraindication to intervention
RRULI: Appendix 1 (TIH + ET) study-specific inclusion criteria:
RRULI: Appendix 1 (TIH + ET) study-specific exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Stendell | Contact | (+61) 468 862 693 | laura.stendell@unimelb.edu.au | |
| Nicole Sheers, PhD | Contact | nsheers@unimelb.edu.au |
| Name | Affiliation | Role |
|---|---|---|
| David Berlowitz, PhD | University of Melbourne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Austin Health | Recruiting | Heidelberg | Victoria | 3084 | Australia |
De-identified participant level data will be made available for research purposes upon approval of written requests at completion of the trial.
Unending - beginning nine months following publication with no end date.
Proposals to access IPD must be directed to the study-specific principal investigator.
Not provided
Not provided
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
Not provided
Not provided
| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided
| OTHER |
| University of Sydney | OTHER |
| University of Florida | OTHER |
Adaptive design Master Protocol investigating multiple interventions within multiple study-specific Appendices.
Not provided
Not provided
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.
Not provided
|
| Up to 6 weeks. |
| D) Acceptability - Rate of participant adherence to the intervention, as assessed by monitoring attendance to treatment sessions.. | Adherence with at least 70% of treatment sessions. | Up to 6 weeks. |
| Baseline and 6-weeks. |
| Penn Spasm Frequency Scale | Self-report measure of upper limb spasticity composed of 2-parts:
| Baseline and 6-weeks. |
| Capabilities of upper extremity questionnaire | 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) | Baseline and 6 weeks |
| Sleep quality and Obstructive Sleep Apnoea (OSA) will be assessed using polysomnography (a sleep study) | In the week prior to the intervention period, a home-based overnight polysomnography test will occur in the participants home to assess for OSA. | 1 day |
| Perceived work of breathing | Modified Borg dyspnoea scale. A scale from 0 (no difficulty breathing) - 10 (very, very severe) - where a higher score is a worse outcome. | Baseline and 6-weeks. |
| Respiratory function will assessed using spirometry. | 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). | Baseline and 6-weeks. |
| Maximal expiratory pressure (MEP) and sniff nasal inspiratory pressure (SNIP) | Respiratory muscle strength | Baseline and 6-weeks |
| Peak cough flow (L/min) | Cough effectiveness | Baseline and 6-weeks |
| Minute Ventilation (Litres) | Ventilation response measurement - physiological. | Baseline and 6-weeks. |
| End of tidal breathing oxygen and carbon dioxide saturation. | Ventilation response measurement - physiological. | Baseline and 6-weeks. |
| Respiratory Rate measured in breaths per minute. | Ventilation response measurement - physiological. | Baseline and 6-weeks. |
| Tidal volume, measured in litres. | Ventilation response measurement - physiological measure. | Baseline and 6-weeks. |
| Ventilation response - assessing mouth pressure (measured in cmH20) | Ventilation response measure - physiological. | Baseline and 6-weeks. |
| Inspiratory time, measured in seconds (s). | Ventilation response measurement - physiological. | Baseline and 6-weeks. |
| Inspiratory and expiratory flow, measured in Litres per second (L/s). | Ventilation response measurement - physiological. | Baseline and 6-weeks. |
| D014947 | Wounds and Injuries |