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Trial registered on ANZCTR


Registration number
ACTRN12618001606279
Ethics application status
Approved
Date submitted
20/09/2018
Date registered
27/09/2018
Date last updated
27/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A preliminary investigation of mechanisms responsible for training-induced increases in strength of partially paralysed muscles of people with spinal cord injury.
Scientific title
A preliminary investigation of mechanisms responsible for training-induced increases in strength of partially paralysed muscles of people with spinal cord injury.
Secondary ID [1] 292460 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal cord injury 304074 0
Condition category
Condition code
Neurological 303410 303410 0 0
Other neurological disorders
Injuries and Accidents 308597 308597 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be a strength training program. One target muscle group will be chosen from either the elbow flexors, elbow extensors, knee flexors or knee extensors. The selected muscle group will be partially paralysed. If more than one muscle group is suitable for inclusion, we will choose the muscle group expected to benefit most from strength training or the muscle group the participant would most like to train. Participants will train the target muscle group on one side of the body, three times a week for six weeks. The training program will adhere to the principles of progressive resistance training. Training will consist of forty maximal contractions in four sets of ten, with two minutes rest between sets. The first two sets of ten repetitions will be isometric contractions and the second two sets of ten repetitions will be concentric contractions. Resistance will be applied manually by a therapist because, with very weak muscles, it is difficult or impossible to provide the target resistance using free weights or isokinetic dynamometry. The therapist will ensure that the resistance is sufficient to exhaust the participant by the end of the set, so that the participant is unable to perform another intense contraction after the tenth. If, over the course of the training program, a participant’s strength increases to the extent that the therapist is no longer able to provide sufficient resistance, weights will be applied to the participant’s limb to provide additional resistance. A record of training sessions will be kept on file. When training sessions are missed, additional sessions will be provided to make up missed sessions.
Intervention code [1] 298640 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302796 0
The primary outcome will be muscle physiological cross sectional area (PCSA) measured using magnetic resonance imaging (MRI) and diffusion tensor imaging (DTI).
Timepoint [1] 302796 0
Post 6 weeks of strength training
Secondary outcome [1] 337049 0
Isometric muscle strength using a isokinetic dynamometer
Timepoint [1] 337049 0
Post 6 weeks of strength training
Secondary outcome [2] 337050 0
Muscle strength using a 13-point manual muscle test
Timepoint [2] 337050 0
Post 6 weeks of strength training
Secondary outcome [3] 337053 0
Mean fascicle length measured using MRI and DTI
Timepoint [3] 337053 0
Post 6 weeks of strength training
Secondary outcome [4] 337054 0
Mean muscle volume measured using MRI
Timepoint [4] 337054 0
Post 6 weeks of strength training
Secondary outcome [5] 337055 0
Mean pennation angle measured using MRI and DTI
Timepoint [5] 337055 0
Post 6 weeks of strength training

Eligibility
Key inclusion criteria
People will be included if they:
1. have any type of SCI (i.e., complete or incomplete as defined by the International Standards for Neurological classification of SCI)
2. have partial paralysis in one of the target muscle groups (i.e., elbow flexor, elbow extensor, knee flexor or knee extensor muscles)
3. have grade 1 to 4 strength on the 6-point manual muscle test (MMT) in the target muscle group
4. are aged 18 years or over at the time of consent
5. are willing to participate in the trial
6. are free of any other type of neurological lesion
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. had any condition preventing testing or training of the target muscle group,
for example unstable fractures in target limb or uncontrollable spasticity.
2. had completed more than 3 consecutive weeks of progressive resistance
training for the target muscle group in the last 3 months.
3. were unable to co-operate.
4. had insufficient English to provide informed consent
5. were unable to remain still in the MRI scanner for the duration of the scan.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
The people analysing the MRI images were blinded to whether the scan was pre or post training.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The mean effects of training on PCSA, mean fascicle length, volume and pennation angle will be estimated from the mean changes over the training period. Confidence intervals will be obtained using the t-distribution.

Recruitment
Recruitment status
Completed
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

Funding & Sponsors
Funding source category [1] 297028 0
Government body
Name [1] 297028 0
NHMRC Program Grant APP1055084
Address [1] 297028 0
16 Marcus Clarke St, Canberra ACT 2601
Country [1] 297028 0
Australia
Primary sponsor type
Government body
Name
Neuroscience Research Australia
Address
Barker St, Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 296037 0
None
Name [1] 296037 0
Address [1] 296037 0
Country [1] 296037 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298213 0
The University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 298213 0
Sydney NSW 2052
Ethics committee country [1] 298213 0
Australia
Date submitted for ethics approval [1] 298213 0
25/07/2017
Approval date [1] 298213 0
01/09/2017
Ethics approval number [1] 298213 0
HC17635

Summary
Brief summary
The study will have a pretest-posttest design and will be conducted on community-dwelling people with SCI. Participants will train a partially paralysed muscle group for six weeks. The purpose of this study is to determine changes in muscle architecture of partially paralysed muscles in response to strength training. An understanding of the underlying causes of strength increases in people with spinal cord injury will help inform the development and provision of rehabilitation programs. Muscle architecture will be measured before and after training using magnetic resonance imaging (MRI) and diffusion tensor imaging (DTI). The participants will receive a strength-training program for the target muscle group three times a week for 6 weeks which will consist of both isometric and concentric contractions. We hypothesise that strength training of partially paralysed muscles will increase muscle physiological cross-sectional area
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76362 0
Prof Robert Herbert
Address 76362 0
NeuRA, 139 Barker St Randwick 2031, NSW, Australia
Country 76362 0
Australia
Phone 76362 0
+61 2 9399 1833
Fax 76362 0
Email 76362 0
r.herbert@neura.edu.au
Contact person for public queries
Name 76363 0
Prof Robert Herbert
Address 76363 0
NeuRA, 139 Barker St Randwick 2031, NSW, Australia
Country 76363 0
Australia
Phone 76363 0
+61 2 9399 1833
Fax 76363 0
Email 76363 0
r.herbert@neura.edu.au
Contact person for scientific queries
Name 76364 0
Prof Robert Herbert
Address 76364 0
NeuRA, 139 Barker St Randwick 2031, NSW, Australia
Country 76364 0
Australia
Phone 76364 0
+61 2 9399 1833
Fax 76364 0
Email 76364 0
r.herbert@neura.edu.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary