Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001317280
Ethics application status
Approved
Date submitted
1/08/2018
Date registered
6/08/2018
Date last updated
12/12/2022
Date data sharing statement initially provided
5/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a weight training exercise program of the 'good arm' on the 'bad arm' after stroke
Scientific title
Contralateral effects of eccentric resistance training on muscle function of the impaired arm of stroke patients
Secondary ID [1] 295598 0
nil known
Universal Trial Number (UTN)
U1111-1217-6769
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 308921 0
Condition category
Condition code
Stroke 307825 307825 0 0
Ischaemic
Stroke 313786 313786 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will conduct eccentric weightlifting (dumbbells) with the healthy arm, which involves lowering a dumbbell.
All training will be instructed and monitored by an investigator and/or a trained exercise physiologist.
The training program runs for 8 weeks, participants come in twice a week for approximately one hour per session. Over the course of 8 weeks, the weights will increase as a percentage of the maximum weight the participants can lift at the start of the experiment (10% 1-repetition maximum weight at the start of the 8 weeks, increasing by 10% each training week).
Before the training program, there will be 2 sessions for baseline testing. These sessions will approximately be 1.5 hours each.
Four weeks after the program there will be a post-measurement which will take around 1.5 hours.
All training and assessment will be done in the 'NeuroRehabilitation and Robotics lab' at the ECU in Joondalup, WA.
Intervention code [1] 301903 0
Rehabilitation
Comparator / control treatment
The same intervention will be delivered to age-matched healthy controls. This is a Phase 0 study.
Control group
Active

Outcomes
Primary outcome [1] 306805 0
Maximal voluntary isometric contraction (MVIC), determined with a load-cell.
Timepoint [1] 306805 0
Baseline measurements (week 1 and 3)
Start of the training program (week 4)
The midpoint of the training program (week 7)
The end of the training program (week 12, primary endpoint)
Followed by an assessment after the end of the program (week 16)
Secondary outcome [1] 349700 0
We will test somatosensory arm function with the KinArm exoskeleton.
Timepoint [1] 349700 0
Baseline (week 1 and 3), start (week 4), midpoint (week 7) and end of the training program (week 12), followed by an assessment after the end of the program (week 16).
Secondary outcome [2] 350319 0
We test if the program has an effect on activities of daily living with the stroke-impact-scale (SIS).
Timepoint [2] 350319 0
Week 1, 12 and 16.

Eligibility
Key inclusion criteria
Patients:
At least 18 years of age
Ischaemic or hemorrhagic stroke more than 6 months ago
Hemiparesis
Able to follow simple instructions
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients:
Not using any electronic neural stimulation devices
Not have participated in an intensive arm strength training protocol in the last 6 months
No fixed contraction deformities

Age-matched controls:
Not have had a stroke
Not using any electronic neural stimulation devices
Not have participated in an intensive arm strength training program in the last 6 months

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)
Allocation is not concealed
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
Other
Other design features
A different group of participants (people without stroke) receiving the same intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A recent meta-analysis (Manca et al. 2017) demonstrated a 17.7% increase in muscle strength in the untrained arm after eccentric training. The reported effect size is moderate-to-large. Because this is a phase 0 trial, we will only include a small number of participants (n= 15) for each group, which makes 30 participants in total.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
8/08/2018
Actual
26/08/2018
Date of last participant enrolment
Anticipated
1/11/2021
Actual
4/02/2019
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
30
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 300175 0
University
Name [1] 300175 0
Edith Cowan University
Country [1] 300175 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
Edith Cowan University
270 Joondalup Drive
Joondalup WA 6027
Australia
Country
Australia
Secondary sponsor category [1] 299585 0
None
Name [1] 299585 0
Address [1] 299585 0
Country [1] 299585 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301007 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 301007 0
Ethics committee country [1] 301007 0
Australia
Date submitted for ethics approval [1] 301007 0
17/05/2018
Approval date [1] 301007 0
02/07/2018
Ethics approval number [1] 301007 0
20232

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

Contacts
Principal investigator
Name 85578 0
Prof Dylan Edwards
Address 85578 0
SMHS NeuroRehabilitation and Robotics Laboratory
Edith Cowan University, Australia
Building 19, Room 19.3105
270 Joondalup Drive
Joondalup WA 6027
Country 85578 0
Australia
Phone 85578 0
+61 863043644
Fax 85578 0
Email 85578 0
[email protected]
Contact person for public queries
Name 85579 0
Onno van der Groen
Address 85579 0
SMHS NeuroRehabilitation and Robotics Laboratory
Edith Cowan University, Australia
Building 19, Room 19.3105
270 Joondalup Drive
Joondalup WA 6027
Country 85579 0
Australia
Phone 85579 0
+61 863043644
Fax 85579 0
Email 85579 0
[email protected]
Contact person for scientific queries
Name 85580 0
Onno van der Groen
Address 85580 0
SMHS NeuroRehabilitation and Robotics Laboratory
Edith Cowan University, Australia
Building 19, Room 19.3105
270 Joondalup Drive
Joondalup WA 6027
Country 85580 0
Australia
Phone 85580 0
+61 863043644
Fax 85580 0
Email 85580 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a feasibility study. No plans are made to make IPD available at this stage.


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.