To determine the effect of early and intensive motor training on motor function in people with spinal cord injury (SCI).
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Total Motor Score (/100 points) 10 weeks after randomisation
Secondary outcome
Neurological status, Spinal Cord Independence Measure - SCIM-SR), ability to
walk (WISCI), quality of life, participants* perceptions about ability to
perform self-selected goals, participants* impressions of therapeutic benefit
and time to discharge.
Background summary
Paralysis is the most obvious effect of spinal cord injury (SCI) on
individuals. Paralysis affects the ability to walk, carry out self-care, live
independently, and participate in work and leisure. There is not yet any cure
for paralysis. The most promising and readily implementable intervention that
could promote neurological recovery and make a lasting difference to the lives
of people with SCI is early and intensive motor training directed at recovery
below the level of the injury. This intervention exploits the early plasticity
of the spinal cord. By maximally activating muscles in the early days after
injury, we will be able to target the spinal cord*s unique capacity for neural
plasticity.
Study objective
To determine the effect of early and intensive motor training on motor
function in people with spinal cord injury (SCI).
Study design
A multi-centre pragmatic randomised controlled trial across at least 5
countries
Intervention
Intervention Group: In addition to standard rehabilitation and care, this
group will receive an extra 12 hours of motor training each week for 10 weeks.
It will involve active and targeted motor training of all affected muscles
below the level of the injury within the context of practice of functional
activities.
Control Group: This group will receive standard rehabilitation and care only.
Study burden and risks
Benefits including improved strength, balance as well as improvements in
functional movements may be noticed. In addition, the investigators will better
understand how to improve outcomes after spinal cord injury.
There are minimal risks involved with participation in this research project
however, there is a small risk that of injury or fall while exercising. There
is also a small risk that if a therapist applies electrical stimulation you may
experience a burn, slight discomfort or autonomic dysreflexia. However, all
training/ therapy will be supervised and prescribed by your treating
physiotherapy team to minimise these risks
Taking part in the study can have the following cons: being assigned to Group 1
(the additional therapy), will results in an extra 12 hours a week for 10 weeks
to therapy which might be tiring or can be found time consuming.
Royal North Shore Hospital Pacific Highway, 1
St Leonards NSW , Australia 2065
AU
Royal North Shore Hospital Pacific Highway, 1
St Leonards NSW , Australia 2065
AU
Listed location countries
Age
Inclusion criteria
People will be eligible to participate if they:
1. have sustained a traumatic or non-traumatic SCI below C4 (neurological
level) in the preceding 8 weeks.
2. have an AIS A lesion with motor function 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
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 eligible to participate if they:
1. have sustained a traumatic or non-traumatic SCI below C4 (neurological
level) in the preceding 8 weeks.
2. have an AIS A lesion with motor function 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | www.ANZCTR.org.au Trial ID nummer ACTRN12621000091808 |
| CCMO | NL78377.015.21 |