Spinal Cord Injury Neurorecovery Collaboration (SCINC) Master Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SCINC Inclusion Criteria:
- •Person with SCI
排除标准
- •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
结局指标
主要结局
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.
时间窗: 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)
时间窗: 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
时间窗: 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.
时间窗: 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..
时间窗: Up to 6 weeks.
Adherence with at least 70% of treatment sessions.
次要结局
- 9-hole Peg test(Baseline and 6-weeks.)
- Pinch grip dynamometer(Baseline and 6-weeks.)
- Penn Spasm Frequency Scale(Baseline and 6-weeks.)
- Capabilities of upper extremity questionnaire(Baseline and 6 weeks)
- Sleep quality and Obstructive Sleep Apnoea (OSA) will be assessed using polysomnography (a sleep study)(1 day)
- Perceived work of breathing(Baseline and 6-weeks.)
- Respiratory function will assessed using spirometry.(Baseline and 6-weeks.)
- Maximal expiratory pressure (MEP) and sniff nasal inspiratory pressure (SNIP)(Baseline and 6-weeks)
- Peak cough flow (L/min)(Baseline and 6-weeks)
- Minute Ventilation (Litres)(Baseline and 6-weeks.)
- End of tidal breathing oxygen and carbon dioxide saturation.(Baseline and 6-weeks.)
- Respiratory Rate measured in breaths per minute.(Baseline and 6-weeks.)
- Tidal volume, measured in litres.(Baseline and 6-weeks.)
- Ventilation response - assessing mouth pressure (measured in cmH20)(Baseline and 6-weeks.)
- Inspiratory time, measured in seconds (s).(Baseline and 6-weeks.)
- Inspiratory and expiratory flow, measured in Litres per second (L/s).(Baseline and 6-weeks.)