Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000914662
Ethics application status
Approved
Date submitted
13/08/2014
Date registered
27/08/2014
Date last updated
16/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Progressive resistance training to increase the strength of partially-paralysed muscles in people with recent spinal cord injury: a within-participant randomised controlled trial.
Scientific title
Progressive resistance training to increase the strength of partially-paralysed muscles in people with recent spinal cord injury: a within-participant randomised controlled trial.
Secondary ID [1] 285129 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal cord injury 292687 0
partial paralysis 292688 0
Condition category
Condition code
Neurological 293004 293004 0 0
Other neurological disorders
Injuries and Accidents 293128 293128 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 293129 293129 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The target muscle group in the experimental limb will be trained according to a progressive resistance program three times a week for 12 weeks. Participants will perform forty maximal contractions in four sets of ten. The first two sets of ten exercises will involve isometric contractions and the second two sets of ten exercises will involve isokinetic contractions. Resistance will be applied through the hands of a therapist. The therapist will always ensure that the resistance is maximal and completely exhausts participants by the end of each set of ten exercises. There will be a 2-minute rest after each set of ten exercises. Emphasis will be placed on progressively increasing the resistance. Resistance applied for each contraction will be measured using a myometer held by the treating therapist. It is estimated that each treatment will take approximately 20 minutes. Weights or strengthening equipment will not be used because of the problems of ensuring maximal resistance is applied throughout range in very weak muscles that are not neurally intact. The intervention will be carried out by qualified physiotherapists and physiotherapist assistants who will be trained in how to carry out the intervention.
Intervention code [1] 289978 0
Rehabilitation
Comparator / control treatment
All participants will continue to receive bilateral functional training. This will involve training for activities of daily living as considered necessary by their treating therapists (e.g., training to transfer, walk, roll and push a wheelchair). Participants will receive any other forms of therapy deemed appropriate for managing fitness, respiratory compromise, contractures, spasticity or pain. In addition, participants will receive any type of strength training program deemed appropriate by treatment therapists to all muscles on both sides of the body with the exception of the target muscle group in the control limb.
Control group
Active

Outcomes
Primary outcome [1] 292864 0
Maximal voluntary Isometric muscle strength at mid muscle length: A myometer will be used to measure peak isometric muscle strength for either the biceps, triceps, hamstrings or quadriceps at its mid muscle length (e.g., 90degrees elbow flexion for the elbow flexor muscle group). The myometer will sit in a constructed apparatus to allow a stable surface for the participant to push against. Strength will be recorded in N but then converted into Nm (using joint angle and distance between joint and force transducer head). Participants will be required to perform 10 maximal isometric muscle contractions or until they fatigue performed with verbal encouragement. There will be a 60-second rest between each trial.
Timepoint [1] 292864 0
12 weeks
Secondary outcome [1] 309825 0
Spasticity: The Ashworth Scale will be used to assess spasticity in the target muscle. The participant will be positioned in supine on an adjustable physiotherapy bed. Only the target muscle will be tested but on both sides of the body. If testing a muscle that primarily flexes a joint, the joint will be placed in a maximally flexed position and moved to a position of maximal extension over one second.
If testing a muscle that primarily extends a joint, the joint will be placed in a maximally extended position and moved to a position of maximal flexion over one second.
Timepoint [1] 309825 0
12 weeks
Secondary outcome [2] 309827 0
Muscle fatigue: A hand held myometer will be used to measure muscle fatigue at its mid muscle length (e.g., 90degrees elbow flexion for the elbow flexor muscle group). Strength will be recorded in N but then converted into Nm (using joint angle and distance between joint and force transducer head). Participants will be required to perform repeated maximal isometric contractions of 4 seconds duration over the period of 3 minutes. They will receive a 4 second rest between each contraction. The mean torque generated over the last three contractions will be divided by the mean torque generated over the first three contractions to calculate the fatigue index.
Timepoint [2] 309827 0
12 weeks
Secondary outcome [3] 309828 0
Participants' pereception of strength: At the completion of the trial participants will be asked to rate their impressions of change in strength of the target muscle group separately for each limb on a 7-point scale where 1 indicates “Almost the same- not much worse”, and 7 indicates “An enormous deal worse”. And the same 7-point scale for if they felt it got better, where 1 indicates "Almost the same- not much better", and 7 indicates "An enormous deal better".
Timepoint [3] 309828 0
12 weeks
Secondary outcome [4] 309829 0
Participants' perception of function: At the completion of the trial participants will be asked to rate their impressions of change in their ability to use the target muscle group for functional activities separately for each limb on a 7-point scale where 1 indicates “Almost the same- not much worse”, and 7 indicates “An enormous deal worse”. And the same 7-point scale for if they felt it got better, where 1 indicates "Almost the same- not much better", and 7 indicates "An enormous deal better".
Timepoint [4] 309829 0
12 weeks

Eligibility
Key inclusion criteria
1. recent complete or incomplete spinal cord injury (SCI, as defined by the International Standards for Neurological classification of SCI) within less than one year, 2. bilateral partial paralysis in one of the target muscle groups (i.e., elbow flexors, elbow extensors, knee flexors or knee extensor muscles), 3. at least grade 3 or 4 strength in the target muscle group on both sides of the body, 4. neurological stability in the strength of the target muscle groups (i.e., not more than a 2/5 point change in Manual Muscle Test over the preceding 3 weeks according to chart records). 5. an inpatient of one of Sydney’s SCI units and are likely to remain there for the duration of their involvement in the trial approximately 13 weeks (or are returning home to the Sydney metropolitan area). 6. aged 16 years or over at the time of consent. 7. willing to participate in the trial. 8. free of any other type of neurological lesion
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have any condition preventing testing or training of the target muscle group. 2. unlikely or unwilling to co-operate (e.g., serious medical condition, cognitive impairment, drug dependency, psychiatric illness, behavioural problems). 3. insufficient English to provide informed consent.

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)
A log will be kept of all new patients with SCI admitted to each SCI unit over the trial period. All these patients will undergo pre-screening for suitability by treating therapists. Initially, physiotherapists from the SCI units who are not involved in the trial will ask suitable in-patients if they are interested in participating. Interested participants will then be visited by a trial staff member who will undertake a pre-screening assessment including reviews of medical history and discussions with the treating doctors and therapists. If the participant meets the inclusion criteria, he/she will be invited to participate and given a Participant Information Sheet for consideration. After baseline assessments, the right or left target muscle group will be randomised to either an experimental or control condition.
A secure random-allocation schedule will be computer-generated prior to commencement of the trial by an independent person and kept at a central off-site location. The randomisation schedule will not be stratified but will be blocked ensuring equal numbers of right and left target muscles groups assigned to the experimental condition. A participant will be entered into the trial when baseline details are logged at the central site and the allocation is provided. The person responsible for central randomisation will notify the treating therapist of the treatment assignment. This will not be disclosed to the blinded assessors.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A secure random-allocation schedule will be computer-generated prior to commencement of the trial by an independent person and kept at a central off-site location. The randomisation schedule will not be stratified but will be blocked ensuring equal numbers of right and left target muscles groups assigned to the experimental condition. A participant will be entered into the trial when baseline details are logged at the central site and the allocation is provided. The person responsible for central randomisation will notify the treating therapist of the treatment assignment. This will not be disclosed to the blinded assessors.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
A sample size of 30 will be required to provide an 80% probability of detecting a between-group difference equivalent to 15% of mean baseline measures on maximal isometric strength of the target muscle group. This assumes a mean initial strength of 75 Nm (15% is 11 Nm) and a SD of the between-group difference of 10 Nm. All power calculations assume an alpha of 0.05, a loss to follow-up of 15% and a correlation between initial strength and outcome of 0.6.

All statistical analyses will be done using the principles of ‘intention to treat’. The t-distribution will be used to estimate 95% CI for between-group (that is, between-limb) differences in change scores for all strength and fatigue outcomes (post-test score minus pre-test score). Paired t-tests will be used to test for significant differences and probabilities of less than 0.05 will be considered significant although the results will be interpreted with respect to the pre-determined minimally worthwhile treatment effects (as defined above). The ‘centile’ routine in Stata (v13; Statacorp, TX, USA) will be used to derive the 95% CIs for median between-group differences for the modified Ashworth and Global Impression of Change data. This method does not make assumptions about the distribution of the data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/09/2014
Actual
15/10/2014
Date of last participant enrolment
Anticipated
9/09/2016
Actual
16/11/2015
Date of last data collection
Anticipated
Actual
8/02/2016
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2827 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 2828 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 2843 0
Royal Rehabilitation Centre Sydney- Ryde
Recruitment postcode(s) [1] 8510 0
2112 - Ryde
Recruitment postcode(s) [2] 8511 0
1590 - St Leonards
Recruitment postcode(s) [3] 8512 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 289753 0
Hospital
Name [1] 289753 0
Prince of Wales Hospital
Country [1] 289753 0
Australia
Primary sponsor type
University
Name
Rehabilitation Studies Unit, The University of Sydney
Address
Kolling Institute, Pacific Highway, Royal North Shore Hospital, St Leonards, NSW 2065
Country
Australia
Secondary sponsor category [1] 288448 0
None
Name [1] 288448 0
Address [1] 288448 0
Country [1] 288448 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291494 0
Northern District Local Health District HREC
Ethics committee address [1] 291494 0
Ethics committee country [1] 291494 0
Australia
Date submitted for ethics approval [1] 291494 0
Approval date [1] 291494 0
01/08/2014
Ethics approval number [1] 291494 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50550 0
Miss Elizabeth Bye
Address 50550 0
Prince of Wales Hospital, Barker st, Randwick, 2031 NSW
Country 50550 0
Australia
Phone 50550 0
+61 2 93825900
Fax 50550 0
Email 50550 0
[email protected]
Contact person for public queries
Name 50551 0
Elizabeth Bye
Address 50551 0
Prince of Wales Hospital, Barker st, Randwick 2031 NSW
Country 50551 0
Australia
Phone 50551 0
+61 2 93825900
Fax 50551 0
Email 50551 0
[email protected]
Contact person for scientific queries
Name 50552 0
Lisa Harvey
Address 50552 0
Kolling Institute, Pacific Highway, Royal North Shore Hospital, St Leonards, NSW, 2065
Country 50552 0
Australia
Phone 50552 0
+61 2 9926 4594
Fax 50552 0
Email 50552 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.