Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000115336
Ethics application status
Approved
Date submitted
17/01/2017
Date registered
23/01/2017
Date last updated
28/01/2024
Date data sharing statement initially provided
4/02/2019
Date results provided
28/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The 200-Rep Trial: 200 repetitions of isolated muscle contractions for partially-paralysed muscles
Scientific title
200 repetitions of isolated muscle contractions per day to increase the strength of partially-paralysed muscles in people with recent spinal cord injury. A randomised controlled trial
Secondary ID [1] 290572 0
Nil
Universal Trial Number (UTN)
U1111-1190-0619
Trial acronym
The 200-Rep Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal cord injury 301027 0
Partial Paralysis 301336 0
Condition category
Condition code
Physical Medicine / Rehabilitation 300819 300819 0 0
Physiotherapy
Neurological 301089 301089 0 0
Other neurological disorders
Injuries and Accidents 301090 301090 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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, six times a week for 8 weeks. The sessions will be supervised in the hospital or rehabilitation centre at which the participant is an inpatient. Training on five of the days will be supervised by a qualified therapist, while the other day will be supervised by a family member/carer where possible or a qualified therapist if they are available. Participants will aim to perform 200 repeat contractions of the target muscle group during each session, and this will be completed within a 30-minute time frame.
The strength training will be progressed as possible. Initially, participants who are very weak and unable to move through a full range of motion (ROM) with gravity eliminated will be encouraged to focus on increasing their ROM during the 200 contractions. Once a participant can readily move 200 times through a full ROM with gravity eliminated, they will be required to move against gravity. Again, initially they will focus on attaining full ROM against gravity during all 200 contractions. Once participants can move 200 times through full ROM against gravity then resistance will be slowly introduced. In addition, participants will also continue to receive usual care (see Control group). The details of the training provided to participants will be recorded by the therapist in a training diary.
Intervention code [1] 296439 0
Rehabilitation
Intervention code [2] 296931 0
Treatment: Other
Comparator / control treatment
All participants in the Control group will continue to receive usual care. This will involve training for activities of daily living as considered necessary by the patient and their treating therapist (e.g. training to transfer). Participants will also receive any type of strength training program deemed appropriate by their treating therapist to all muscles with the exception of the target muscle group. The target muscle group can receive up to two sessions per week of progressive resistance training if this is thought to be appropriate by the treating physiotherapist.
Control group
Active

Outcomes
Primary outcome [1] 300280 0
Muscle strength: Muscle strength will be measured using the Manual Muscle Test on a 13-point scale. This scale is adapted from the traditional 0 to 5-point Manual Muscle Test but utilises pluses and minuses.
Timepoint [1] 300280 0
8 weeks
Secondary outcome [1] 329599 0
Participants’ perceptions 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 on a 15-point scale where -7 indicates “a very great deal worse”, 0 indicates “no change” and +7 indicates “a very great deal better”.
Timepoint [1] 329599 0
8 weeks
Secondary outcome [2] 330145 0
Participants’ perceptions 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 on a 15-point scale where -7 indicates “a very great deal worse”, 0 indicates “no change” and +7 indicates “a very great deal better” for each muscle group.
Timepoint [2] 330145 0
8 weeks
Secondary outcome [3] 330146 0
Therapist’s expectation of final strength: Prior to the baseline assessment, the treating therapist will be asked to estimate how much the target muscle will improve in strength over the study period. Specifically, the therapist will be asked to estimate the grade that they expect the target muscle to be at the end of the 8-week study period (on a 13-point manual muscle test). This prediction will be used to calculate the difference between predicted and actual muscle strength at 8-weeks.
Timepoint [3] 330146 0
8 weeks

Eligibility
Key inclusion criteria
A person will be eligible to participate if they:
* 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
* 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)
* have less than grade 3 strength in the target muscle as measured by a manual muscle test (MMT).
* 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)
* are aged 16 years or over at the time of consent
* are willing to participate in the trial
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People will be excluded if they:
* have any condition preventing testing or training of the target muscle group
* have any other known neurological condition or neurological injury other than SCI
* are unable to co-operate (e.g. have a serious medical condition, cognitive impairment, drug dependency, psychiatric illness, or behavioural problems)
* do not speak the national language sufficiently well 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)
Allocation concealment will occur via sealed opaque envelopes which will be sequentially numbered and held by an independent person at an off-site location. Initially, physiotherapists from the Spinal Cord Injury Units will ask suitable inpatients if they are interested in participating. Interested participants will then be visited by the site investigator who will undertake a pre-screening assessment. If the participant meets the inclusion criteria, he/she will be invited to participate and provide consent. Once the baseline assessments of the participant has been completed, trial staff will contact the independent person, who will open the next envelope and reveal the group allocation.
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 be blocked (1:1) and stratified (by site) using small permuted blocks to ensure equal (or near equal) numbers of participants are randomised to the treatment and control condition at each site (provided the last block is completed). .
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Regression models will be used to determine between-group differences. Results will be
interpreted with respect to the pre-determined minimally worthwhile treatment effects. The ‘centile’ routine in Stata (v9.2; Statacorp, TX, USA) may also be used to derive the 95% CIs for median between-group differences for data which is not normally distributed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/02/2017
Actual
3/02/2017
Date of last participant enrolment
Anticipated
Actual
10/12/2018
Date of last data collection
Anticipated
4/02/2019
Actual
4/02/2019
Sample size
Target
120
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 7123 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 7126 0
Prince of Wales Hospital - Randwick
Recruitment hospital [3] 7223 0
Royal Rehabilitation Hospital - Coorabel/Moorong - Ryde
Recruitment hospital [4] 7224 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 14884 0
2065 - St Leonards
Recruitment postcode(s) [2] 14887 0
2031 - Randwick
Recruitment postcode(s) [3] 14988 0
2112 - Ryde
Recruitment postcode(s) [4] 14989 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 8502 0
India
State/province [1] 8502 0
Country [2] 8549 0
Bangladesh
State/province [2] 8549 0
Country [3] 21246 0
China
State/province [3] 21246 0
Guangzhou

Funding & Sponsors
Funding source category [1] 295175 0
Other
Name [1] 295175 0
Slater and Gordon Health Projects and Research Fund
Country [1] 295175 0
Australia
Funding source category [2] 295280 0
Government body
Name [2] 295280 0
icare lifetime care
Country [2] 295280 0
Australia
Primary sponsor type
Hospital
Name
Northern Sydney Local Health District (Kolling Institute, Royal North Shore Hospital), John Walsh Centre for Rehabilitation Research
Address
Reserve Road, St Leonards, NSW 2065, Australia.
Country
Australia
Secondary sponsor category [1] 294001 0
None
Name [1] 294001 0
None
Address [1] 294001 0
None
Country [1] 294001 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296525 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 296525 0
Ethics committee country [1] 296525 0
Australia
Date submitted for ethics approval [1] 296525 0
11/07/2016
Approval date [1] 296525 0
24/10/2016
Ethics approval number [1] 296525 0
HREC/16/HAWKE/251

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

Contacts
Principal investigator
Name 70586 0
Ms Lydia Chen
Address 70586 0
Spinal Injuries Unit, Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065
Country 70586 0
Australia
Phone 70586 0
+61 02 94632732
Fax 70586 0
Email 70586 0
[email protected]
Contact person for public queries
Name 70587 0
Lydia Chen
Address 70587 0
Spinal Injuries Unit, Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065
Country 70587 0
Australia
Phone 70587 0
+61 02 94632732
Fax 70587 0
Email 70587 0
[email protected]
Contact person for scientific queries
Name 70588 0
Lisa Harvey
Address 70588 0
John Walsh Centre for Rehabilitation Research, University of Sydney, Kolling Institute
Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065, Australia
Country 70588 0
Australia
Phone 70588 0
+61 2 9926 4594
Fax 70588 0
Email 70588 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant baseline and 8 week assessment data on strength
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
All participant level data are available in the supplementary file on the website (https://doi.org/10.1038/s41393-020-0439-1)


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
SourceTitleYear of PublicationDOI
EmbaseThe effects of 10,000 voluntary contractions over 8 weeks on the strength of very weak muscles in people with spinal cord injury: a randomised controlled trial.2020https://dx.doi.org/10.1038/s41393-020-0439-1
N.B. These documents automatically identified may not have been verified by the study sponsor.