Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000197831
Ethics application status
Approved
Date submitted
24/08/2020
Date registered
25/02/2021
Date last updated
21/01/2024
Date data sharing statement initially provided
25/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Electrical stimulation combined with strength training to increase the strength of very weak muscles in people with recent spinal cord injury. A randomised controlled trial
Scientific title
Electrical stimulation combined with strength training to increase the strength of very weak muscles in people with recent spinal cord injury. A randomised controlled trial
Secondary ID [1] 302112 0
Nil
Universal Trial Number (UTN)
U1111-1264-1715
Trial acronym
eStim Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury 318741 0
Partial paralysis 318742 0
Condition category
Condition code
Physical Medicine / Rehabilitation 316756 316756 0 0
Physiotherapy
Neurological 316757 316757 0 0
Other neurological disorders
Injuries and Accidents 316758 316758 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, 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.
Intervention code [1] 318416 0
Rehabilitation
Intervention code [2] 318417 0
Treatment: Other
Intervention code [3] 319102 0
Treatment: Devices
Comparator / control treatment
All participants in the Control group will continue to receive usual care. This 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. This will include many interventions such as training for activities of daily living as considered necessary by the patient and their treating therapist (e.g. training to transfer). Participants are also able to 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 muscles trained and the dose of this training is at the discretion of the treating physiotherapist.
Control group
Active

Outcomes
Primary outcome [1] 324883 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] 324883 0
Baseline and following completion of the intervention training (8 weeks)
Secondary outcome [1] 386093 0
Participants’ perceptions about ability to perform self-selected goals: Participants’ perceptions about their ability to perform two self-selected goals will be rated on a 11-point numerical rating scale where 0 reflects “totally unable to perform” and 10 reflects “totally able to perform”. This assessment has been designed specifically for this trial and whilst its psychometric properties have not been tested, the assessment is based on the widely used numerical rating scale, as well as the Goal Attainment Scale and Canadian Occupational Performance Measure. At baseline participants will be asked to nominate two goals of therapy that they would like to achieve in the next 8 weeks. The goals will be set in conjunction with their treating therapists. The goals will need to relate to a motor activity that relies on the strength of the target muscle. The goals will need to follow the SMART principles, namely specific, measurable, attainable, realistic and time-bound. Once the two goals have been identified, participants will be asked to rate their ability to perform each goal at baseline and 8 weeks.
Timepoint [1] 386093 0
Baseline and following completion of the intervention training (8 weeks)
Secondary outcome [2] 386094 0
Participants’ perceptions of change in 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 [2] 386094 0
Following completion of the intervention training (8 weeks)
Secondary outcome [3] 386095 0
Participants’ perceptions of change in 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 for functional activities on a 15-point impression of change scale score where -7 indicates “a very great deal worse”, 0 indicates “no change” and +7 indicates “a very great deal better” for the target muscle.
Timepoint [3] 386095 0
Following completion of the intervention training (8 weeks)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

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)
The allocation schedule will be concealed from potential participants and from all staff associated with the trial . Randomisation will occur after completion of the baseline assessments. The Site Principal Investigator will log the participant’s details into Redcap. The Site Principal Investigator will then be automatically notified of treatment assignment. Trial staff and hospital staff at the site will at this point be aware of a participant’s assignment but this will not be disclosed to the blinded assessors or any other Associate Investigators or Site Principal Investigators.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A secure random allocation schedule will be generated independently and uploaded onto Redcap (an electronic data capture system). 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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/03/2021
Actual
28/06/2021
Date of last participant enrolment
Anticipated
Actual
17/04/2023
Date of last data collection
Anticipated
Actual
12/06/2023
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 17322 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 17323 0
Royal Rehabilitation Hospital - Coorabel/Moorong - Ryde
Recruitment postcode(s) [1] 31048 0
2065 - St Leonards
Recruitment postcode(s) [2] 31049 0
2112 - Ryde
Recruitment outside Australia
Country [1] 23389 0
Bangladesh
State/province [1] 23389 0

Funding & Sponsors
Funding source category [1] 306536 0
Other
Name [1] 306536 0
Slater and Gordon Health Projects and Research Fund
Country [1] 306536 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] 307065 0
None
Name [1] 307065 0
None
Address [1] 307065 0
None
Country [1] 307065 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306732 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 306732 0
Ethics committee country [1] 306732 0
Australia
Date submitted for ethics approval [1] 306732 0
24/08/2020
Approval date [1] 306732 0
13/11/2020
Ethics approval number [1] 306732 0

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

Contacts
Principal investigator
Name 104830 0
Ms Lydia Chen
Address 104830 0
Spinal Injuries Unit, Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065
Country 104830 0
Australia
Phone 104830 0
+61 2 94632732
Fax 104830 0
Email 104830 0
[email protected]
Contact person for public queries
Name 104831 0
Lydia Chen
Address 104831 0
Spinal Injuries Unit, Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065
Country 104831 0
Australia
Phone 104831 0
+61 2 94632732
Fax 104831 0
Email 104831 0
[email protected]
Contact person for scientific queries
Name 104832 0
Joanne Glinsky
Address 104832 0
John Walsh Centre for Rehabilitation Research, University of Sydney, Kolling Institute Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065, Australia
Country 104832 0
Australia
Phone 104832 0
+61 2 99264594
Fax 104832 0
Email 104832 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 study protocol.
How or where can data be obtained?
As a supplementary document available via publication website (link will be provided when study is accepted and published)


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.