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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06871254
Registration number
NCT06871254
Ethics application status
Date submitted
27/02/2025
Date registered
11/03/2025
Date last updated
8/08/2025
Titles & IDs
Public title
Spinal Cord Injury Neurorecovery Collaboration
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Scientific title
Spinal Cord Injury Neurorecovery Collaboration (SCINC) Master Protocol
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Secondary ID [1]
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SCINC_MASTER
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Universal Trial Number (UTN)
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Trial acronym
SCINC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injuries
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Condition category
Condition code
Injuries and Accidents
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Fractures
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Injuries and Accidents
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Other injuries and accidents
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Therapeutic Intermittent Hypoxia (TIH) + Exercise Training (ET)
Experimental: RRULI: Appendix 1 - In this first arm of SCINC, adults with chronic tetraplegia will be assigned to the RRULI: Appendix 1 intervention.
Other interventions: 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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline and 6-weeks.
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Primary outcome [2]
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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)
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline and 6 week follow-up
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Primary outcome [3]
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B) No deterioration
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline and 6 week follow-up
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Primary outcome [4]
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C) Safety - Incidence of Autonomic Dysreflexia (AD) episodes occurring during the intervention period for each individual participant.
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Assessment method [4]
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Fewer than two AD events that fail to resolve with participants usual, community interventions.
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Timepoint [4]
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Up to 6 weeks.
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Primary outcome [5]
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D) Acceptability - Rate of participant adherence to the intervention, as assessed by monitoring attendance to treatment sessions..
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Assessment method [5]
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Adherence with at least 70% of treatment sessions.
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Timepoint [5]
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Up to 6 weeks.
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Secondary outcome [1]
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9-hole Peg test
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Assessment method [1]
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A test of upper limb dexterity and function. This test will be undertaken using the dominant hand.
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Timepoint [1]
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Baseline and 6-weeks.
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Secondary outcome [2]
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Pinch grip dynamometer
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Assessment method [2]
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Pinch strength
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Timepoint [2]
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Baseline and 6-weeks.
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Secondary outcome [3]
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Penn Spasm Frequency Scale
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline and 6-weeks.
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Secondary outcome [4]
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Capabilities of upper extremity questionnaire
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Assessment method [4]
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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)
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Timepoint [4]
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Baseline and 6 weeks
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Secondary outcome [5]
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Sleep quality and Obstructive Sleep Apnoea (OSA) will be assessed using polysomnography (a sleep study)
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Assessment method [5]
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In the week prior to the intervention period, a home-based overnight polysomnography test will occur in the participants home to assess for OSA.
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Timepoint [5]
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1 day
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Secondary outcome [6]
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Perceived work of breathing
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Assessment method [6]
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Modified Borg dyspnoea scale. A scale from 0 (no difficulty breathing) - 10 (very, very severe) - where a higher score is a worse outcome.
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Timepoint [6]
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Baseline and 6-weeks.
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Secondary outcome [7]
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Respiratory function will assessed using spirometry.
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Assessment method [7]
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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).
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Timepoint [7]
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Baseline and 6-weeks.
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Secondary outcome [8]
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Maximal expiratory pressure (MEP) and sniff nasal inspiratory pressure (SNIP)
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Assessment method [8]
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Respiratory muscle strength
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Timepoint [8]
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Baseline and 6-weeks
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Secondary outcome [9]
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Peak cough flow (L/min)
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Assessment method [9]
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Cough effectiveness
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Timepoint [9]
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Baseline and 6-weeks
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Secondary outcome [10]
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Minute Ventilation (Litres)
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Assessment method [10]
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Ventilation response measurement - physiological.
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Timepoint [10]
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Baseline and 6-weeks.
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Secondary outcome [11]
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End of tidal breathing oxygen and carbon dioxide saturation.
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Assessment method [11]
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Ventilation response measurement - physiological.
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Timepoint [11]
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Baseline and 6-weeks.
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Secondary outcome [12]
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Respiratory Rate measured in breaths per minute.
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Assessment method [12]
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Ventilation response measurement - physiological.
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Timepoint [12]
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Baseline and 6-weeks.
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Secondary outcome [13]
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Tidal volume, measured in litres.
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Assessment method [13]
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Ventilation response measurement - physiological measure.
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Timepoint [13]
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Baseline and 6-weeks.
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Secondary outcome [14]
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Ventilation response - assessing mouth pressure (measured in cmH20)
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Assessment method [14]
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Ventilation response measure - physiological.
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Timepoint [14]
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Baseline and 6-weeks.
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Secondary outcome [15]
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Inspiratory time, measured in seconds (s).
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Assessment method [15]
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Ventilation response measurement - physiological.
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Timepoint [15]
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Baseline and 6-weeks.
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Secondary outcome [16]
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Inspiratory and expiratory flow, measured in Litres per second (L/s).
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Assessment method [16]
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Ventilation response measurement - physiological.
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Timepoint [16]
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Baseline and 6-weeks.
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Eligibility
Key inclusion criteria
SCINC
- Person with SCI
SCINC
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2027
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Actual
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Sample size
Target
24
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Austin Health - Heidelberg
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Recruitment postcode(s) [1]
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3084 - Heidelberg
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Melbourne
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Institute of Breathing and Sleep
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Address [1]
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Country [1]
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Other collaborator category [2]
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Government body
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Name [2]
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Austin Health
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Neuroscience Research Australia
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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The University of New South Wales
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Address [4]
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Country [4]
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Other collaborator category [5]
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Other
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Name [5]
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University of Sydney
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Address [5]
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Country [5]
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Other collaborator category [6]
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Other
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Name [6]
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University of Florida
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Address [6]
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Country [6]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT06871254
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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David Berlowitz, PhD
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Address
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University of Melbourne
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Laura Stendell
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Address
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Country
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Phone
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(+61) 468 862 693
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
De-identified participant level data will be made available for research purposes upon approval of written requests at completion of the trial.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
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When will data be available (start and end dates)?
Unending - beginning nine months following publication with no end date.
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Available to whom?
Proposals to access IPD must be directed to the study-specific principal investigator.
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06871254
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