[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583048":3},{"organization":4,"outcomesModule":7,"designInfo":76,"detailedDescription":84,"studyPopulation":75,"armGroups":85,"interventions":92,"overallOfficials":100,"centralContacts":104,"locations":113,"responsibleParty":131,"collaborators":133,"id":147,"slug":75,"hasResults":148,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":148,"sex":154,"minAge":155,"maxAge":75,"enrollmentInfo":156,"targetDuration":75,"studyType":159,"phases":160,"briefSummary":161,"conditions":162,"keywords":75,"overallStatus":116,"whyStopped":75,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":173},{"fullName":5,"class":6},"University of Melbourne","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":27,"otherOutcomes":75},[9,13,17,20,24],{"measure":10,"description":11,"timeFrame":12},"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:\n\nA) 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.\n\nD) 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.",{"measure":14,"description":15,"timeFrame":16},"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.\n\nGRIP: Grip strength will be measured according to a standardised procedure. A threshold of 5.0 kg will be used.\n\nMIP: Respiratory muscle strength will be measured according to standard procedures. A threshold of 10cmH20 will be used.","Baseline and 6 week follow-up",{"measure":18,"description":19,"timeFrame":16},"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.",{"measure":21,"description":22,"timeFrame":23},"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.","Up to 6 weeks.",{"measure":25,"description":26,"timeFrame":23},"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.",[28,31,34,37,41,45,48,51,55,58,61,63,65,68,71,73],{"measure":29,"description":30,"timeFrame":12},"9-hole Peg test","A test of upper limb dexterity and function. This test will be undertaken using the dominant hand.",{"measure":32,"description":33,"timeFrame":12},"Pinch grip dynamometer","Pinch strength",{"measure":35,"description":36,"timeFrame":12},"Penn Spasm Frequency Scale","Self-report measure of upper limb spasticity composed of 2-parts:\n\n1. Spasm frequency: scale 0 (no spasm) - 4 (spasms occurring more than 10 times per hour).\n2. Spasm severity: scale 1 (mild) - 3 (severe). A higher score indicates a worse outcome for both components of the scale.",{"measure":38,"description":39,"timeFrame":40},"Capabilities of upper extremity questionnaire","Questionnaire assessing upper limb function. Scored on a 7-point scale representing self-perceived difficulty:\n\n1= \"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",{"measure":42,"description":43,"timeFrame":44},"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",{"measure":46,"description":47,"timeFrame":12},"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.",{"measure":49,"description":50,"timeFrame":12},"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).",{"measure":52,"description":53,"timeFrame":54},"Maximal expiratory pressure (MEP) and sniff nasal inspiratory pressure (SNIP)","Respiratory muscle strength","Baseline and 6-weeks",{"measure":56,"description":57,"timeFrame":54},"Peak cough flow (L\u002Fmin)","Cough effectiveness",{"measure":59,"description":60,"timeFrame":12},"Minute Ventilation (Litres)","Ventilation response measurement - physiological.",{"measure":62,"description":60,"timeFrame":12},"End of tidal breathing oxygen and carbon dioxide saturation.",{"measure":64,"description":60,"timeFrame":12},"Respiratory Rate measured in breaths per minute.",{"measure":66,"description":67,"timeFrame":12},"Tidal volume, measured in litres.","Ventilation response measurement - physiological measure.",{"measure":69,"description":70,"timeFrame":12},"Ventilation response - assessing mouth pressure (measured in cmH20)","Ventilation response measure - physiological.",{"measure":72,"description":60,"timeFrame":12},"Inspiratory time, measured in seconds (s).",{"measure":74,"description":60,"timeFrame":12},"Inspiratory and expiratory flow, measured in Litres per second (L\u002Fs).",null,{"allocation":77,"interventionModel":78,"interventionModelDescription":79,"primaryPurpose":80,"observationalModel":75,"timePerspective":75,"maskingInfo":81},"NA","SINGLE_GROUP","Adaptive design Master Protocol investigating multiple interventions within multiple study-specific Appendices.","TREATMENT",{"masking":82,"maskingDescription":83,"whoMasked":75},"NONE","SCINC Master protocol:\n\n\\- Where multiple simultaneous appendices\u002Finterventions are evaluated the intent is to keep the independent assessor blinded to the intervention allocation.\n\nRRULI: Appendix 1:\n\n\\- The outcome assessor will be independent of the providers of therapy.","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\u002FIII 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.",[86],{"label":87,"type":88,"description":89,"interventionNames":90},"RRULI: Appendix 1","EXPERIMENTAL","In this first arm of SCINC, adults with chronic tetraplegia will be assigned to the RRULI: Appendix 1 intervention.",[91],"Other: Therapeutic Intermittent Hypoxia (TIH) + Exercise Training (ET)",[93],{"type":6,"name":94,"description":95,"armGroupLabels":96,"otherNames":97},"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.",[87],[98,99],"Therapeutic acute intermittent hypoxia (tAIH)","Acute intermittent hypoxia (AIH)",[101],{"name":102,"affiliation":5,"role":103},"David Berlowitz, PhD","PRINCIPAL_INVESTIGATOR",[105,110],{"name":106,"role":107,"phone":108,"phoneExt":75,"email":109},"Laura Stendell","CONTACT","(+61) 468 862 693","laura.stendell@unimelb.edu.au",{"name":111,"role":107,"phone":75,"phoneExt":75,"email":112},"Nicole Sheers, PhD","nsheers@unimelb.edu.au",[114],{"facility":115,"status":116,"city":117,"state":118,"zip":119,"country":120,"countryCode":121,"cosmosGeoPoint":122,"geoPoint":127,"contacts":128},"Austin Health","RECRUITING","Heidelberg","Victoria","3084","Australia","AU",{"type":123,"coordinates":124},"Point",[125,126],145.06667,-37.75,{"lat":126,"lon":125},[129],{"name":106,"role":107,"phone":130,"phoneExt":75,"email":109},"(+61) 0468 862 693",{"type":132,"investigatorFullName":75,"investigatorTitle":75,"investigatorAffiliation":75,"oldNameTitle":75,"oldOrganization":75},"SPONSOR",[134,137,139,141,143,145],{"name":135,"class":136},"Institute of Breathing and Sleep","UNKNOWN",{"name":115,"class":138},"OTHER_GOV",{"name":140,"class":6},"Neuroscience Research Australia",{"name":142,"class":6},"The University of New South Wales",{"name":144,"class":6},"University of Sydney",{"name":146,"class":6},"University of Florida","100583048",false,"NCT06871254","Spinal Cord Injury Neurorecovery Collaboration","Spinal Cord Injury Neurorecovery Collaboration (SCINC) Master Protocol","SCINC","SCINC Inclusion Criteria:\n\n\\- Person with SCI\n\nSCINC Exclusion Criteria:\n\n\\- Proven contraindication to intervention\n\nRRULI: Appendix 1 (TIH + ET) study-specific inclusion criteria:\n\n* Adults \\> 18 years of age\n* Able to independently ventilate\n* Chronic SCI (\\>1 years post-injury or impairment onset)\n* Tetraplegia (C2-T1 level of injury)\n* Evidence of motor incomplete paralysis in the upper limb below the neurological level of injury\n* Have a documented management plan for their AD if it occurs.\n\nRRULI: Appendix 1 (TIH + ET) study-specific exclusion criteria:\n\n* Pregnancy\n* Medical instability, including current or recent (within the previous 6 weeks) infection or inflammation\n* Current or recent (within the previous 6 weeks) pressure ulcers or cutaneous lesions\n* Poorly controlled diabetes\n* An episode of AD in the previous 6 months that required medical intervention to resolve\n* Significant other neurological, psychiatric, pulmonary, cardiovascular, orthopaedic, or oncological conditions.\n* Currently taking part in another clinical trial\n* Upper limb contracture","ALL","18 Years",{"count":157,"type":158},24,"ESTIMATED","INTERVENTIONAL",[77],"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.",[163],"Spinal Cord Injuries","2025-08-04",{"date":166,"type":167},"2025-08-08","ACTUAL",{"date":169,"type":167},"2025-03-01",{"date":171,"type":158},"2027-12-31",{"name":5,"class":6},1]