Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000870853
Ethics application status
Approved
Date submitted
18/02/2021
Date registered
6/07/2021
Date last updated
2/09/2022
Date data sharing statement initially provided
6/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of Heart Rate Variability Feedback to improve heart-brain function after spinal cord injury - The Spinal cord injury, Mind and HeART or (SMART) study
Scientific title
The effect of a novel neuro-cardiac self-regulation therapy on autonomic and neural function after spinal cord injury: A Randomised Clinical Trial
Secondary ID [1] 302669 0
Nil
Universal Trial Number (UTN)
U1111-1263-6575
Trial acronym
The SMART trial
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury (SCI) 320072 0
Autonomic dysfunction 320073 0
Condition category
Condition code
Neurological 318118 318118 0 0
Other neurological disorders
Cardiovascular 318120 318120 0 0
Other cardiovascular diseases
Mental Health 318628 318628 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study comprises a randomised controlled trial that involves the use of a neuro-cardiac self-regulation intervention (heart rate variability feedback, HRV-F).

The trial consists of a parallel randomised two-arm controlled trial (HRV-F compared to a no treatment control) with up to 60 in each group, and assessed at baseline, immediate post HRV-F (i.e. approximately 10 weeks), and 6 and 12-month post baseline.

Intervention protocol to be used in the trial involves HRV-F.
HRV-F involves a participant’s heart rate variability and breathing delivered in a dynamic feedback form on standard laptops utilising specialised HRV feedback software (Procomp 2, Thought Technology Ltd; TGA approved: 119650). The goal is for the participant to learn to regulate their HRV and breathing patterns, called resonance frequency breathing, that is, slow relaxed diaphragmatic breathing around 3-7 breaths per minute that has a regulating effect on the autonomic nervous system, so that respiratory sinus arrhythmia and baroreflex gain are maximised. This is taught by training participants in slow breathing and supplying visual/auditory feedback of HRV activity related to their breathing.

The HRV-F intervention protocol to be trialled consists of up to 10 training sessions over a period of at least 10 weeks. The ten training sessions will involve a mixture of face-to-face formal sessions (2 hours duration each) in the research lab as well as online/telephone sessions (at home sessions, up to 1-hour duration). Sessions will include:
(1) introduction to HRV-F and slow breathing techniques
(2) determination of participant’s resonance frequency breathing
(3) HRV-F supervised practice, and
(4) education about autonomic balance and health and transfer of HRV-F skills to everyday life and stressful contexts.

Home-based training will involve daily homework related to the skills learned in the face-to-face formal HRV-F sessions in the clinic will be assigned and a diary used by participants to log homework activities. Homework activities will include:
(1) tasks such as controlled and paced breathing as taught in the face-to face sessions
(2) measuring HRV using HRV phone-based apps each day
(3) psychological self-management strategies such as self-monitoring of mood, anxiety, breath/heart rate, pain/fatigue and sleep, and
(4) visualisation strategies to enhance their self-regulation of HRV and breathing. A portable single finger sensor/chest strap (or a wristwatch) will be connected to the participant’s smartphone, with exportable biometric data measurement that will be sent to the research team after each session. These data will also be used to monitor adherence at home and elsewhere as applicable.

Experienced health professionals trained in the strategies to be used will deliver training sessions. The homework activities and diary have been designed specifically for the RCT. Participants will be encouraged to apply the intervention skills as needed in their daily lives. Follow-up telephone sessions on a monthly basis will occur up to 12 months post entry into the trial, in which participants are rung by the research team and their progress discussed.
Intervention code [1] 319391 0
Treatment: Devices
Comparator / control treatment
The comparator will be the no treatment arm: this represents a control group receiving no treatment. Participants randomized into this group will not be receiving HRV-F intervention but usual standard care plus a short telephone call every week in the first 10 weeks to match the contact received by the intervention group. The telephone call will be based around how they are going generally. In addition, they will also be contacted on a monthly basis up to 12 months.

Usual standard care following acute stabilization for people with SCI include multidisciplinary rehabilitation and supportive care, provided in an inpatient, outpatient settings or at home. Multidisciplinary rehabilitation can include various interventions such as physical therapy (e.g. strength training, robotics, functional electrical stimulation), occupational therapy (e.g. wheelchair training, splinting), respiratory and pain management, and psychological therapy. Supportive care can include assistance with bed positioning, transfers and activities of daily living (e.g. personal hygiene, dressing, bladder and bowel management).
Control group
Active

Outcomes
Primary outcome [1] 326103 0
Short-term changes in heart rate variability (HRV) time domain from the recorded electrocardiograph (ECG) trace, assessing the amount of the HR variability observed.
Timepoint [1] 326103 0
Baseline (pre-intervention) to 10 weeks post commencement of intervention (short term outcome).
Primary outcome [2] 327092 0
Short-term changes in heart rate variability (HRV) frequency domain from the recorded electrocardiograph (ECG) trace, assessing the underlying rhythms of the HR variability observed by quantifying the power within component bands.
Timepoint [2] 327092 0
Baseline (pre-intervention) to 10 weeks post commencement of intervention (short term outcome).
Primary outcome [3] 327093 0
Short-term changes in cerebral blood circulation, assessed by mean/beat-to-beat cerebral blood flow velocity (CBF-V) of the basal cerebral arteries using a transcranial doppler sonography (fTCD) non-invasive system.
Timepoint [3] 327093 0
Baseline (pre-intervention) to 10 weeks post commencement of intervention (short term outcome).
Secondary outcome [1] 390130 0
Long-term changes in HRV time domain from the recorded ECG trace, assessing the amount of the HR variability observed.
Timepoint [1] 390130 0
Baseline to 6 and 12-months post commencement of intervention (long term outcome).
Secondary outcome [2] 390131 0
Long-term changes in heart rate variability (HRV) frequency domain from the recorded electrocardiograph (ECG) trace, assessing the underlying rhythms of the HR variability observed by quantifying the power within component bands.
Timepoint [2] 390131 0
Baseline to 6 and 12-months post commencement of intervention (long term outcome).
Secondary outcome [3] 390132 0
Long-term changes in cerebral blood circulation, assessed by mean/beat-to-beat cerebral blood flow velocity (CBF-V) of the basal cerebral arteries using a transcranial doppler sonography (fTCD) non-invasive system.
Timepoint [3] 390132 0
Baseline to 6 and 12-months post commencement of intervention (long term outcome).
Secondary outcome [4] 390133 0
Autonomic cardiovascular control measured by electrocardiography and non-invasive dual finger cuff from which composite measure of changes in blood pressure (BP) variability (Continuous BP) , HRV and baroreflex function/sensitivity will be recorded.
Timepoint [4] 390133 0
Baseline, 10 weeks, 6 months and 12 months post commencement of intervention
• Baseline to week 10 (short term outcome)
• Baseline to 6 or 12 months (longer term outcome).
Secondary outcome [5] 390134 0
Cerebral electrical activity, assessed from the electroencephalography (EEG) trace recorded using the International 10–20 montage system, sampled at 1025 Hz covering all hemispheric regions.
Timepoint [5] 390134 0
Baseline, 10 weeks, 6 months and 12 months post commencement of intervention
• Baseline to week 10 (short term outcome)
• Baseline to 6 or 12 months (longer term outcome).
Secondary outcome [6] 390135 0
Regional SpO2 Cerebral tissue oxygenation assessed by near infrared spectroscopy (NIRS) of cranial tissues.
Timepoint [6] 390135 0
Baseline, 10 weeks, 6 months and 12 months post commencement of intervention
• Baseline to week 10 (short term outcome)
• Baseline to 6 or 12 months (longer term outcome).
Secondary outcome [7] 390143 0
Mental fatigue, measured via the assessment of blink rate from the electrooculography (EOG) recorded using four sensors placed above/below/sidewise the eye).
Timepoint [7] 390143 0
Baseline, 10 weeks, 6 months and 12 months post commencement of intervention
• Baseline to week 10 (short term outcome)
• Baseline to 6 or 12 months (longer term outcome).
Secondary outcome [8] 390144 0
Skin conductance assessed by surface electrodes on fingers and toes (results will be analysed as one outcome to estimate the integrity of sympathetic sudomotor pathways based on level of injury)
Timepoint [8] 390144 0
Baseline, 10 weeks, 6 months and 12 months post commencement of intervention
• Baseline to week 10 (short term outcome)
• Baseline to 6 or 12 months (longer term outcome).
Secondary outcome [9] 390145 0
Blood volume pulse amplitude assessed by light sensor on finger.
Timepoint [9] 390145 0
Baseline, 10 weeks, 6 months and 12 months post commencement of intervention
• Baseline to week 10 (short term outcome)
• Baseline to 6 or 12 months (longer term outcome).
Secondary outcome [10] 390146 0
Breath rate assessed by a sensitive respiratory band around chest/abdominal area.
Timepoint [10] 390146 0
Baseline, 10 weeks, 6 months and 12 months post commencement of intervention
• Baseline to week 10 (short term outcome)
• Baseline to 6 or 12 months (longer term outcome).
Secondary outcome [11] 390147 0
Peripheral body temperature assessed by surface electrodes on fingers (measures of sympathetic activity).
Timepoint [11] 390147 0
Baseline and 10 weeks, 6 months and 12 months post commencement of intervention
• Baseline to week 10 (short term outcome)
• Baseline to 6 or 12 months (longer term outcome).
Secondary outcome [12] 390148 0
Secondary Health Condition: The SCI Secondary Conditions Scale will be used, It is a composite and a validated psychometric tool to assess impact of secondary complications in people with spinal cord injury.
Timepoint [12] 390148 0
Baseline, 10 weeks, 6 months and 12 months post commencement of intervention
• Baseline to week 10 (short term outcome)
• Baseline to 6 or 12 months (longer term outcome).
Secondary outcome [13] 390149 0
Cognitive function, assessed as using the Neuropsychiatry Unit
Cognitive Assessment (NUCOG) tool (extent and severity of cognitive impairments).
Timepoint [13] 390149 0
Baseline, 10 weeks, 6 months and 12 months post commencement of intervention
• Baseline to week 10 (short term outcome)
• Baseline to 6 or 12 months (longer term outcome).
Secondary outcome [14] 390151 0
Psychological function - Anxiety symptoms/disorder, assessed by Generalised Anxiety Disorder Scale.
Timepoint [14] 390151 0
Baseline, 10 weeks, 6 months and 12 months post commencement of intervention
• Baseline to week 10 (short term outcome)
• Baseline to 6 or 12 months (longer term outcome).
Secondary outcome [15] 390152 0
Psychological function - Depressive mood, assessed by Patient Health Questionnaire-9.
Timepoint [15] 390152 0
Baseline, 10 weeks, 6 months and 12 months post commencement of intervention
• Baseline to week 10 (short term outcome)
• Baseline to 6 or 12 months (longer term outcome).
Secondary outcome [16] 390153 0
Psychosocial function - Pain assessed by the ISCoS Basic Pain dataset (subjective measure), including pain interference and pain intensity measured by 0 – 10 Numerical Rating Scale.
Timepoint [16] 390153 0
Baseline, 10 weeks, 6 months and 12 months post commencement of intervention
• Baseline to week 10 (short term outcome)
• Baseline to 6 or 12 months (longer term outcome).
Secondary outcome [17] 390154 0
Psychosocial function - Fatigue, assessed by the Fatigue Severity Scale.
Timepoint [17] 390154 0
Baseline, 10 weeks, 6 months and 12 months post commencement of intervention
• Baseline to week 10 (short term outcome)
• Baseline to 6 or 12 months (longer term outcome).
Secondary outcome [18] 390155 0
Psychosocial function - Sleep function, assessed by the Pittsburgh Sleep Quality Assessment.
Timepoint [18] 390155 0
Baseline, 10 weeks, 6 months and 12 months post commencement of intervention
• Baseline to week 10 (short term outcome)
• Baseline to 6 or 12 months (longer term outcome).
Secondary outcome [19] 390156 0
Psychosocial function - Pain catastrophising, assessed by the Pain Catastrophizing Scale.
Timepoint [19] 390156 0
Baseline, 10 weeks, 6 months and 12 months post commencement of intervention
• Baseline to week 10 (short term outcome)
• Baseline to 6 or 12 months (longer term outcome).
Secondary outcome [20] 390157 0
Personal factors - Resilience, assessed by the Connor-Davidson Resilience Scale - Short Form.
Timepoint [20] 390157 0
Baseline, 10 weeks, 6 months and 12 months post commencement of intervention
• Baseline to week 10 (short term outcome)
• Baseline to 6 or 12 months (longer term outcome).
Secondary outcome [21] 390158 0
Quality of life, assessed by the Euro Quality of Life 5-Dimensional 5-level (EQ-5D-5L).
Timepoint [21] 390158 0
Baseline, 10 weeks, 6 months and 12 months post commencement of intervention
• Baseline to week 10 (short term outcome)
• Baseline to 6 or 12 months (longer term outcome).
Secondary outcome [22] 390159 0
Participation - Community participation, assessed by the World Health Organisation Disability Assessment Scale (WHODAS) participation domain.
Timepoint [22] 390159 0
Baseline, 10 weeks, 6 months and 12 months post commencement of intervention
• Baseline to week 10 (short term outcome)
• Baseline to 6 or 12 months (longer term outcome).
Secondary outcome [23] 390160 0
Consumer perception and satisfaction, assessed by self-reported questionnaire (2 items) designed specially for this study.
Timepoint [23] 390160 0
At 10 weeks post intervention.
Secondary outcome [24] 390161 0
Self-reported direct and indirect costs for economic evaluation, assessed using weekly self-monitoring diary
Timepoint [24] 390161 0
Daily diaries (Participants will be asked to complete their diary daily at least 5 days of seven, for the 12-month period).
Secondary outcome [25] 390162 0
Self-report medical complications: Adverse events occur during the conduct of study will be captured on participants diaries according to Common Terminology Criteria for Adverse Events, assessed using weekly self-monitoring diary
Timepoint [25] 390162 0
Daily diaries (Participants will be asked to complete their diary daily at least 5 days of seven, for the 12-month period).
Secondary outcome [26] 390163 0
Self-reported medications, assessed using weekly self-monitoring diary
Timepoint [26] 390163 0
Daily diaries (Participants will be asked to complete their diary daily at least 5 days of seven, for the 12-month period).
Secondary outcome [27] 390166 0
Longitudinal assessment of fatigue, measured on 0 – 10 Numerical Rating Scale, assessed using weekly self-monitoring diary
Timepoint [27] 390166 0
Daily diaries (Participants will be asked to complete their diary daily at least 5 days of seven, for the 12-month period).
Secondary outcome [28] 390167 0
Longitudinal assessment of pain, measured on 0 – 10 Numerical Rating Scale, assessed using weekly self-monitoring diary
Timepoint [28] 390167 0
Daily diaries (Participants will be asked to complete their diary daily at least 5 days of seven, for the 12-month period).
Secondary outcome [29] 390168 0
Longitudinal assessment of sleep, measured on 0 – 10 Numerical Rating Scale, assessed using weekly self-monitoring diary
Timepoint [29] 390168 0
Daily diaries (Participants will be asked to complete their diary daily at least 5 days of seven, for the 12-month period).
Secondary outcome [30] 390169 0
Longitudinal assessment of mood, measured on 0 – 10 Numerical Rating Scale, assessed using weekly self-monitoring diary
Timepoint [30] 390169 0
Daily diaries (Participants will be asked to complete their diary daily at least 5 days of seven, for the 12-month period).
Secondary outcome [31] 390170 0
Psychological function - Post-traumatic stress symptoms/disorder, assessed by Post-traumatic Stress Disorder Checklist (PCL-5) - Short form (Exploratory outcome).
Timepoint [31] 390170 0
Baseline, 10 weeks, 6 months and 12 months post commencement of intervention
• Baseline to week 10 (short term outcome)
• Baseline to 6 or 12 months (longer term outcome).
Secondary outcome [32] 393758 0
Psychosocial function - Social support, assessed by the Social Support Questionnaire (SSQ6) - Short Form (Exploratory outcome).
Timepoint [32] 393758 0
Baseline, 10 weeks, 6 months and 12 months post commencement of intervention
• Baseline to week 10 (short term outcome)
• Baseline to 6 or 12 months (longer term outcome).
Secondary outcome [33] 393759 0
Psychosocial function - Obstructive sleep apnea, assessed by the Berlin Questionnaire (Exploratory outcome).
Timepoint [33] 393759 0
Baseline, 10 weeks, 6 months and 12 months post commencement of intervention
• Baseline to week 10 (short term outcome)
• Baseline to 6 or 12 months (longer term outcome).
Secondary outcome [34] 393760 0
Personal factors - Self-efficacy, assessed by the Moorong Self-efficacy Scale (Exploratory outcome).
Timepoint [34] 393760 0
Baseline, 10 weeks, 6 months and 12 months post commencement of intervention
• Baseline to week 10 (short term outcome)
• Baseline to 6 or 12 months (longer term outcome).
Secondary outcome [35] 393761 0
Participation - Return to work, assessed by the Return to Work questionnaire (Exploratory outcome).
Timepoint [35] 393761 0
At 6 months and 12 months post commencement of intervention.
Secondary outcome [36] 393762 0
Personal factors - Substance consumption, assessed by the The Alcohol, Smoking and Substance Involvement Screening Test (WHO ASSIST) - Short version (Exploratory outcome).
Timepoint [36] 393762 0
Baseline, 10 weeks, 6 months and 12 months post commencement of intervention
• Baseline to week 10 (short term outcome)
• Baseline to 6 or 12 months (longer term outcome).
Secondary outcome [37] 393763 0
Personal factors - Coping skills, assessed by the Coping Orientation to Problems Experienced (COPE) inventory - Brief version (Exploratory outcome).
Timepoint [37] 393763 0
Baseline, 10 weeks, 6 months and 12 months post commencement of intervention
• Baseline to week 10 (short term outcome)
• Baseline to 6 or 12 months (longer term outcome).
Secondary outcome [38] 393764 0
Personal factors - Appraisal, assessed by the Appraisal of Disability: Primary and Secondary Scale (ADAPSS) - brief version (Exploratory outcome).
Timepoint [38] 393764 0
Baseline, 10 weeks, 6 months and 12 months post commencement of intervention
• Baseline to week 10 (short term outcome)
• Baseline to 6 or 12 months (longer term outcome).
Secondary outcome [39] 396907 0
Composite measure of environmental factors including questions related to carer, family and compensation status (Exploratory outcome).
Timepoint [39] 396907 0
Baseline, 10 weeks, 6 months and 12 months post commencement of intervention
• Baseline to week 10 (short term outcome)
• Baseline to 6 or 12 months (longer term outcome).

Eligibility
Key inclusion criteria
A participant will be included if:
(i) aged 18-80 years
(ii) English speaking
(iii) have sustained a SCI of traumatic/non-traumatic aetiology with complete/incomplete lesions
(iv) at least 12 months post-SCI
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A participant will be excluded if:
(i) there is evidence of severe cognitive impairment, e.g. moderate to severe traumatic brain injury (TBI) or dementia or determined by cognitive screening (e.g. NUCOG);
(ii) evidence of psychiatric disorder, e.g. bipolar disorder or psychoses or chronic severe depression disorder, determined by medical history or psychiatric interview (e.g. PHQ9);
(iii) taking ß-blockers;
(iv) compromised respiratory functions, e.g. mechanical ventilation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A computer-generated random allocation schedule will be formulated prior to the starting of the study by an independent person who is not involved in recruitment. The allocation sequence will be uploaded to a web-based software (REDCap) system with limited access. After the participant passes the screening process and completes the baseline assessment, an allocation from REDCap will be revealed. The participant will be considered to have enrolled in the study at this point.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequence will be generated on excel spreadsheet using a “rand” function and then be uploaded on the online web-based software (REDcap) by one of the researchers not involved in treatment and assessment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power analyses for RCT stage 1: For a=.05, small to moderate effect size of 0.3, with 2 groups (HRV-F and time-wait control) of 50 in each group and 4 assessment periods, using repeated measures linear mixed models, the estimated statistical power is >80%. To allow for reduced participant numbers due to dropout (e.g. sickness), death, or unwillingness to continue, we will recruit up to 120 participants. The conservative effect size used in the sample size calculations relates to improvement in HRV balance (mostly increased sympathetic activity which is significantly lowered as a result of SCI) over time that was based on findings from other non-selective studies of these therapies and our previous work, given HRV-F therapy has never been applied to adults with SCI before.

Control of bias and Statistical Analyses: Selection bias will be controlled using multivariable analysis to adjust for confounders (e.g. sex, level of lesion), as well as stratifying for lesions “T4 level and above” versus “T level and below”. Socio-demographics of the samples will be determined using parametric (e.g., t-tests) and non-parametric (e.g. Ch-square tests). Change over time and differences between groups over time will involve repeated measures ANOVA/ liner mixed model analyses. Regression techniques (e.g. logistic) may be used to determine contributors to efficacy and to the primary outcome measures (HRV and blood basal artery blood flow). Secondary analyses will be performed on secondary measures such as sleep, cognitive performance, EEG, mental health, fatigue and so on. An in-built cost-effective and cost-utility analysis will also be undertaken.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18272 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 18273 0
Royal Rehab - Ryde - Ryde
Recruitment postcode(s) [1] 32341 0
2065 - St Leonards
Recruitment postcode(s) [2] 32342 0
2112 - Ryde

Funding & Sponsors
Funding source category [1] 307108 0
Government body
Name [1] 307108 0
NSW Ministry of Health
Country [1] 307108 0
Australia
Funding source category [2] 307495 0
University
Name [2] 307495 0
The University of Sydney
Country [2] 307495 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
City Road,
Camperdown/Darlington NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 307679 0
None
Name [1] 307679 0
Address [1] 307679 0
Country [1] 307679 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307222 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 307222 0
Ethics committee country [1] 307222 0
Australia
Date submitted for ethics approval [1] 307222 0
26/10/2020
Approval date [1] 307222 0
02/12/2020
Ethics approval number [1] 307222 0
2020/ETH02554

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106462 0
Prof Ashley Craig
Address 106462 0
John Walsh Centre for Rehabilitation Research
Northern Clinical School, Faculty of Medicine and Health, The University of Sydney
Level 12, Kolling Institute of Medical Research, Royal North Shore Hospital
10, Westbourne St
St Leonards NSW 2065.
Country 106462 0
Australia
Phone 106462 0
+61 02 99264925
Fax 106462 0
+61 02 99264045
Email 106462 0
[email protected]
Contact person for public queries
Name 106463 0
Ilaria Pozzato
Address 106463 0
John Walsh Centre for Rehabilitation Research
Northern Clinical School, Faculty of Medicine and Health, The University of Sydney
Level 12, Kolling Institute of Medical Research, Royal North Shore Hospital
10, Westbourne St
St Leonards NSW 2065.
Country 106463 0
Australia
Phone 106463 0
+61 02 99264962
Fax 106463 0
+61 02 99264045
Email 106463 0
[email protected]
Contact person for scientific queries
Name 106464 0
Ashley Craig
Address 106464 0
John Walsh Centre for Rehabilitation Research
Northern Clinical School, Faculty of Medicine and Health, The University of Sydney
Level 12, Kolling Institute of Medical Research, Royal North Shore Hospital
10, Westbourne St
St Leonards NSW 2065.
Country 106464 0
Australia
Phone 106464 0
+61 02 99264925
Fax 106464 0
+61 02 99264045
Email 106464 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Non-identifiable individual participant data of primary outcomes only.
When will data be available (start and end dates)?
Data will not be available till 2 years after the end date of the study (anticipated date: 30 July 2028). However, given this project will comprise PhD theses, when data will be made available will also depend on the PhD timeline.
Available to whom?
Collaborators and independent researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor and Principal Investigator.
Available for what types of analyses?
For meta-analyses only.
How or where can data be obtained?
Data may be obtained from the repository of journals where the results of the study will be published or on request to the Principal Investigator [email protected].


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.