None listed
Conditions
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.
Interventions
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 i
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).
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
People will be eligible to participate if they: 1. have sustained a traumatic or non-traumatic SCI of any neurological level in the preceding 10 weeks. 2. have an AIS A lesion with motor function (in a key or non-key muscle) more than three levels below the motor level (on one or both sides), or an AIS C or AIS D lesion (as defined by the International Standards for the Neurological Classification of SCI). 3. 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). 4. have been cleared by the medical team to commence rehabilitation (as documented in the participant’s medical files). 5. are likely to remain an inpatient for the next 10 weeks. 6. understand and voluntarily sign an informed consent form prior to any study related assessments/procedures being conducted. 7. are willing and able to adhere to the study visit schedule and other protocol requirements.
Exclusion criteria
People will be excluded if they: 1. 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. 2. are unable to provide informed consent. 3. are family members of the research staff. 4. 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). 5. are unable to speak the official language of the country of recruitment to provide consent.
Outcome results
None listed