None listed
Conditions
Brief summary
Weakness is a debilitating problem for people with spinal cord injury (SCI) and while we know a lot about how to strengthen fully innervated muscles, we know very little about how to strengthen the very weak muscles of people with SCI. It is believed that the addition of ES to strength training might further enhance the neural and muscular adaptations required to increase strength in the very weak muscles of people with SCI. The underlying mechanisms are not well understood but are thought to be due to enhanced neural plasticity in combination with hypertrophy of the muscle. Increasing the strength in very weak muscles is crucial to the future independence of people with SCI. Even small changes in strength can have a big impact on function. This study will be a pragmatic multi-centre, single-blind between-participant randomised controlled trial. The aim is to compare the effectiveness of strength training combined with ES and usual care, versus usual care alone for increasing voluntary strength in very weak muscles of people with recent SCI. One target muscle for each participant will be selected from the following groups of muscles: the elbow flexors, elbow extensors, wrist flexors, wrist extensors, knee flexors, knee extensor muscles, ankle dorsiflexors or ankle plantarflexors. Eligible participants will be randomised to one of two groups, either the Treatment group or the Control group. Participants allocated to the Treatment group will receive ES and voluntary strength training to the target muscle, three times a week for 8 weeks in combination with usual care. Participants in the Treatment Group will aim to perform a total of 120 repetitions of isolated contractions of the target muscle during each session, as well as usual care. Participants allocated to the Control group will receive usual care alone. The intervention will be provided for 8 weeks. All outcomes will be collected at baseline and at 8 weeks.
Interventions
One target muscle group will be selected on one side of the body from the following muscles: the elbow flexors, elbow extensors, wrist flexors, wrist extensors, knee flexors, knee extensors, ankle dorsiflexors or ankle plantarflexors. This will be chosen by the physiotherapist in consultation with the participant. A target muscle group in participants allocated to the Treatment group will be trained once a day, three times a week for 8 weeks. The sessions will be supervised in the hospital or re
One target muscle group will be selected on one side of the body from the following muscles: the elbow flexors, elbow extensors, wrist flexors, wrist extensors, knee flexors, knee extensors, ankle dorsiflexors or ankle plantarflexors. This will be chosen by the physiotherapist in consultation with the participant. A target muscle group in participants allocated to the Treatment group will be trained once a day, three times a week for 8 weeks. The sessions will be supervised in the hospital or rehabilitation centre at which the participant is an inpatient. All training will be supervised on a one-to-one basis by a qualified physiotherapist, or a physiotherapy assistant/student (under the guidance of a physiotherapist). Participants will aim to perform a total of 120 repetitions of isolated contractions of the target muscle during each session. The first 6 sets of 10 repetitions will involve electrical stimulation (ES) with the participant voluntarily contracting the target muscle. The remaining 60 repetitions will involve ES-evoked muscle contractions without the participant voluntarily contracting the target muscle. All training with and without the participant voluntarily contracting the target muscle will follow the principles of progressive resistance training. This training will be conducted at a moderate to high intensity (12-16 on the Borg RPE scale) and will be progressed as the strength of the participant improves. The duration of the training session will be approximately 30 minutes. ES will be delivered through a portable neurostimulator commonly used in clinical practice for this purpose. Participants will be given a standard warning for the use of electrical stimulation includes watching for signs of skin burn or autonomic dysreflexia. Stimulation parameters will be set at 50 Hz frequency, 300 microseconds pulse width, on:off ratio of 6:6 seconds and delivered at up to 100mA stimulation amplitude (according to individuals’ tolerance to ES current density) In addition. participants will also continue to receive usual care (see Control group). This usual care will consist of physiotherapy as is typically provided at the site. It is anticipated that this will be equivalent to between 3 to 6, one hour sessions per week of physiotherapy.
Sponsors
Northern Sydney Local Health District (Kolling Institute, Royal North Shore Hospital), John Walsh Centre for Rehabilitation Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
A person will be eligible to participate if they: 1. have a recent complete or incomplete SCI (as defined by the International Standards for Neurological classification of SCI) that was sustained less than six months prior 2. have partial paralysis in a major muscle group on one side of the body (i.e., elbow flexors or extensors, wrist flexors or extensors, knee flexors or extensors, ankle dorsiflexors or plantarflexors) 3. have less than grade 3 on the 13 point manual muscle scale (that is they are unable to move through full range against gravity) 4. are an inpatient of one of the participating SCI units and are likely to remain there for the duration of their involvement in the trial (i.e., approximately 9 weeks) or are being discharged home to the local area surrounding the hospital 5. are aged 18 years or over at the time of consent 6. are willing to participate in the trial 7. are free of any other type of neurological condition or injury
Exclusion criteria
A person is excluded from participation if they: 1. have any condition preventing testing or training of the target muscle 2. are not able to evoke a strong electrically stimulated contraction with the training parameters 3. have paralysis in the target muscle 4. are unable to co-operate (e.g. a serious medical condition, cognitive impairment, drug dependency, psychiatric illness, and behavioural problem) 5. do not speak the national language sufficiently well to provide informed consent
Outcome results
None listed