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Trial registered on ANZCTR


Registration number
ACTRN12621000091808
Ethics application status
Approved
Date submitted
24/11/2020
Date registered
1/02/2021
Date last updated
21/04/2021
Date data sharing statement initially provided
1/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Early and intensive motor training (versus usual care) to enhance neurological recovery and function in people with spinal cord injury (SCI)
Scientific title
Early and intensive motor training (versus usual care) to enhance neurological recovery and function in people with spinal cord injury (SCI)
Secondary ID [1] 301897 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SCI-MT trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
spinal cord injury 319316 0
Condition category
Condition code
Physical Medicine / Rehabilitation 317287 317287 0 0
Physiotherapy
Injuries and Accidents 318077 318077 0 0
Other injuries and accidents
Neurological 318294 318294 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A multi-centre Australia-wide pragmatic randomised controlled trial will be undertaken to compare 10 weeks of early and intensive motor training in addition to usual care compare to usual care alone for people with recent spinal cord injury.

Participants allocated to the intervention group will receive an extra 12 hours of motor training each week for 10 weeks (in additional to usual physiotherapy and usual rehabilitation). This will be provided as 2 hours per day from Monday to Saturday, or in larger blocks of therapy on Saturdays and Sundays, or any combination of both. The therapy will involve active and targeted motor training of all affected muscles below the level of the injury (for example, a typical therapy session for a person with incomplete tetraplegia and some motor function in the lower limbs may include active cycling with electrical stimulation, strengthening exercises for the quadricep muscles and walking on a treadmill with assistance). Training will be supplemented with biofeedback, electrical stimulation, mental imagery, somatosensory stimulation, robotics and computer game-based therapy where available and appropriate. Treatments will be individualised to the needs of each participant with a focus on training that addresses each person's specific motor problem. The training will be provided on a one-to-one basis by a physiotherapist, occupational therapist or suitably qualified healthcare professional. The level of intensity of the exercises will not be directly measured but left to the discretion of the treating therapist. Adherence will be recorded using the International Spinal Cord Injury Physical Therapy-Occupational Therapy Basic Data Set (Version 1.2).
Intervention code [1] 318783 0
Rehabilitation
Comparator / control treatment
Participants allocated to the control group will receive usual physiotherapy and usual rehabilitation. This will consist of physiotherapy and occupational therapy as is typically provided. It is anticipated that this will be equivalent to between 3 to 6 sessions per week of both occupational therapy and physiotherapy with some also receiving group classes, hydrotherapy and sessions with exercise physiologists (depending on the sites where participants are recruited). Any of these sessions may include some of the components of the package of treatment provided to intervention group participants provided it is offered to all participants of both groups without consideration of which group the participant has been allocated to.
Control group
Active

Outcomes
Primary outcome [1] 325356 0
Total Motor Score (/100 points) according to the International Standards for Neurological Classification of Spinal Cord Injury.
Timepoint [1] 325356 0
10 weeks after randomisation
Secondary outcome [1] 387599 0
American Spinal Injuries Association Impairment Scale (AIS) according to the International Standards for Neurological Classification of Spinal Cord Injury.
Timepoint [1] 387599 0
10 weeks after randomisation
Secondary outcome [2] 387600 0
Upper Extremity Motor Score (/50 points) according to the International Standards for Neurological Classification of Spinal Cord Injury.
Timepoint [2] 387600 0
10 weeks after randomisation
Secondary outcome [3] 387601 0
Lower Extremity Motor Score (/50 points) according to the International Standards for Neurological Classification of Spinal Cord Injury.
Timepoint [3] 387601 0
10 weeks after randomisation
Secondary outcome [4] 387602 0
Total Sensory Score (/224 points) according to the International Standards for Neurological Classification of Spinal Cord Injury.
Timepoint [4] 387602 0
10 weeks after randomisation
Secondary outcome [5] 387603 0
Spinal Cord Independence Measure Version III - Self Report (SCIM-SR)
Timepoint [5] 387603 0
10 weeks and 6 months after randomisation
Secondary outcome [6] 387604 0
Walking Index for Spinal Cord Injuries Version II (WISCI)
Timepoint [6] 387604 0
10 weeks and 6 months after randomisation
Secondary outcome [7] 387610 0
World Health Organization Quality of Life - BREF (WHOQOL- BREF)
Timepoint [7] 387610 0
10 weeks and 6 months after randomisation
Secondary outcome [8] 387611 0
EUROQOL - 5D Health Questionnaire (EQ- 5D - 5L)
Timepoint [8] 387611 0
10 weeks and 6 months after randomisation
Secondary outcome [9] 387612 0
Participants' perceptions about ability to perform self-selected goals using a 11-point analogue scale where "0 reflects “totally unable to perform” and 10 reflects “totally able to perform”.
Timepoint [9] 387612 0
10 weeks and 6 months after randomisatioin
Secondary outcome [10] 387613 0
Participants' impression of therapeutic benefit using a 15-point scale where zero indicates no change, +7 indicates “a very great deal better” and -7 indicates “a very great deal worse”
Timepoint [10] 387613 0
10 weeks and 6 months after randomisation
Secondary outcome [11] 387614 0
Time to discharge as reported by participants or trial staff.(through a study-specific questionnaire)
Timepoint [11] 387614 0
6 months after randomisation

Eligibility
Key inclusion criteria
People will be eligible to participate if they:
- have sustained a traumatic or non-traumatic SCI below C4 (neurological level) in the preceding 8 weeks
- have an AIS A lesion with motor function more than three levels below the motor level, or an AIS C or AIS D lesion (as defined by the International Standards for the Neurological Classification of SCI)
- are male or female, over the age of 16 years at the time of signing informed consent (additional consent from a parent or guardian will be attained for those aged under 18 years).
- have been cleared by the medical team to commence rehabilitation (as documented in the participant's medical files)
- are likely to remain an inpatient for the next 10 weeks
- understand and voluntarily sign an informed consent form prior to any study related assessments/procedures being conducted
- are willing and able to adhere to the study visit schedule and other protocol requirements
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People will be excluded if they:
- have any significant medical or physical condition (including pregnancy) or psychiatric illness that could prevent the person from participating in the trial, or would place the person at an unacceptable risk if he/she were to participate
- are unable to provide informed consent
- are family members of the research staff
- are participating in another clinical trial that involves motor training of the key muscles (as defined by the International Standards for Neurological Classification of SCI)
- do not speak English

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)
The hospital and trial physiotherapist responsible for determining participants' eligibility to the trial will not have access to the randomisation schedule. Randomisation will occur following consent, screening and baseline assessment of participants. The site principal investigator will log the participants' details into REDCap (electronic data management platform). The site principal investigator will then be notified of treatment assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A secure random allocation schedule will be generated independently and uploaded onto REDCap. The schedule will be concealed from potential participants and from all staff associated with the trial except one investigator. This investigator will be responsible for generating the randomisation schedule and will not be involved in recruitment. He will be the only person who will have access to the randomisation schedule.
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
The primary analysis will be conducted on an intention-to -treat basis. It will compare mean Total Motor scores of the Intervention and Control groups at 10 weeks, adjusted for baseline Total Motor score and the stratification variables (site and severity of injury). The effect of the intervention will be estimated as the adjusted mean difference in Total Motor score together with its 95% confidence interval. If more than 5% of data are missing for the primary analysis, multiple imputation will be used to account for missing data provided the missing at random assumption appears plausible. The multiple imputation procedure will use all available baseline and follow-up observations. Secondary outcomes will be analysed in a similar way but the dependent variable will be transformed to approximate a normal distribution where necessary and possible.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 17794 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 17795 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 17796 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 17797 0
Royal Talbot Rehabilitation Centre - Kew
Recruitment hospital [5] 17798 0
Hampstead Rehabilitation Centre - Northfield
Recruitment hospital [6] 17799 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [7] 18081 0
Royal Rehabilitation Hospital - Coorabel/Moorong - Ryde
Recruitment postcode(s) [1] 31651 0
2031 - Randwick
Recruitment postcode(s) [2] 31652 0
2065 - St Leonards
Recruitment postcode(s) [3] 31653 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 31654 0
3101 - Kew
Recruitment postcode(s) [5] 31655 0
5085 - Northfield
Recruitment postcode(s) [6] 31656 0
6150 - Murdoch
Recruitment postcode(s) [7] 32069 0
2112 - Ryde

Funding & Sponsors
Funding source category [1] 306311 0
Government body
Name [1] 306311 0
New South Wales Ministry of Health Spinal Cord Injury Research Grant
Address [1] 306311 0
NSW Ministry of Health
1 Reserve Road
St Leonards NSW 2065
Country [1] 306311 0
Australia
Funding source category [2] 308401 0
Other
Name [2] 308401 0
Wings for Life
Address [2] 308401 0
Fürstenallee 4
5020 Salzburg
Austria
Country [2] 308401 0
Austria
Primary sponsor type
University
Name
University of Sydney
Address
Level 3, Administration Building (F23), The University of Sydney, NSW 2008
Country
Australia
Secondary sponsor category [1] 306806 0
None
Name [1] 306806 0
Address [1] 306806 0
Country [1] 306806 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306527 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 306527 0
Kolling Building, Level 13
Royal North Shore Hospital
St Leonards NSW 2065
Ethics committee country [1] 306527 0
Australia
Date submitted for ethics approval [1] 306527 0
25/09/2020
Approval date [1] 306527 0
19/11/2020
Ethics approval number [1] 306527 0

Summary
Brief summary
A multi-centre pragmatic randomised controlled trial will be undertaken to compare 10 weeks of early and intensive motor training with usual care for people with recent SCI. The primary endpoint will be Total Motor Score (/100 points) at 10 weeks to reflect neurological recovery. Secondary endpoints will be other measures of neurological status, the Spinal Cord Independence Measure (SCIM), ability to walk, psychological status, time to discharge, improvement on self-selected goals and participants' impressions of therapeutic benefit/change at 10 weeks and 6 months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104166 0
Prof Lisa Harvey
Address 104166 0
John Walsh Centre for Rehabilitation Research (The University of Sydney)
Level 12, Kolling Institute,
Royal North Shore Hospital,
St Leonards, NSW 2065
Country 104166 0
Australia
Phone 104166 0
+61 2 99264594
Fax 104166 0
Email 104166 0
l.harvey@usyd.edu.au
Contact person for public queries
Name 104167 0
Prof Lisa Harvey
Address 104167 0
John Walsh Centre for Rehabilitation Research (The University of Sydney)
Level 12, Kolling Institute,
Royal North Shore Hospital,
St Leonards, NSW 2065
Country 104167 0
Australia
Phone 104167 0
+61 2 99264594
Fax 104167 0
Email 104167 0
l.harvey@usyd.edu.au
Contact person for scientific queries
Name 104168 0
Prof Lisa Harvey
Address 104168 0
John Walsh Centre for Rehabilitation Research (The University of Sydney)
Level 12, Kolling Institute,
Royal North Shore Hospital,
St Leonards, NSW 2065
Country 104168 0
Australia
Phone 104168 0
+61 2 99264594
Fax 104168 0
Email 104168 0
l.harvey@usyd.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results