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Trial registered on ANZCTR


Registration number
ACTRN12622000711718
Ethics application status
Approved
Date submitted
6/04/2022
Date registered
17/05/2022
Date last updated
21/05/2024
Date data sharing statement initially provided
17/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Using muscle strength as a predictor for walking ability after stroke
Scientific title
Using muscle strength as a predictor for walking ability after stroke
Secondary ID [1] 306668 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 325602 0
muscle strength 325603 0
Condition category
Condition code
Stroke 322964 322964 0 0
Haemorrhagic
Stroke 322965 322965 0 0
Ischaemic

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
After a stroke, reduced muscle strength is a main cause of reduced ability to walk.
In this observational study, we'll examine the relationship between muscle strength and walking ability, and using muscle strength to predict walking speed at 6 months. Muscle strength will be measured using manual muscle test (MMT) and for muscles scoring at 0 or 1 on the MMT, a surface electromyography (EMG) reading will be recorded to ascertain the actual amount of muscle activity.
We'll measure the muscle strength for all eligible stroke survivors who were initially non-ambulant post stroke onset. Walking speed will be measured when the stroke survivor is able to walk independently.
The follow up period will be at 1, 2,3,4,8,12, 26 and 52 weeks following stroke onset.

Muscle strength testing procedures:
- 4 trials will be performed to ascertain muscle strength for hip and knee extensors, as well as ankle dorsiflexor and plantar flexors
- the participants will lie in supine with their particle limb positioned at 90 degrees of hip and knee flexion on a stool as standardised positions for testing of muscle strength
- if the participant scores 0 or 1 on manual muscle test, we will perform EMG for relevant muscle groups only
- EMG electrodes will be positioned longitudinally over the innervation zone and distal tendon to ascertain muscle activity, and a third electrode as reference on a boney prominence
- the actual reading from EMG machine will be recorded for all 4 attempts
- the testing will be performed by either the site physiotherapist or the researcher
- the approximate testing procedure will take 10-15minutes, and we will assess muscle strength at all timepoints in this study up to 26 weeks.
At 52 weeks (12 months), we will follow up with phone call to participants who were not able to walk at 6 months to ascertain walking ability at 12 months.

Intervention code [1] 323105 0
Diagnosis / Prognosis
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330729 0
walking speed will be measured using 10 meter walk test.
We will use a stopwatch to determine time taken to walk the 10m walk track
Timepoint [1] 330729 0
The muscle strength and walking speed will be measured on 1,2,3,4,8,12 and 26 weeks
At 52 weeks, we will call the participant and ascertain their walking ability if they were not able to walk at 26 weeks. We will not be measuring muscle strength or walking speed at 52 weeks.
Secondary outcome [1] 407360 0
Hip extensor muscle strength
Tested using manual muscle testing
Timepoint [1] 407360 0
The muscle strength will be measured on 1,2,3,4,8,12 and 26 weeks following stroke onset
Secondary outcome [2] 408719 0
knee extensor muscle strength
Tested using manual muscle testing
Timepoint [2] 408719 0
The muscle strength will be measured on 1,2,3,4,8,12 and 26 weeks following stroke onset
Secondary outcome [3] 408720 0
ankle dorsiflexor muscle strength
Tested using manual muscle testing
Timepoint [3] 408720 0
The muscle strength will be measured on 1,2,3,4,8,12 and 26 weeks following stroke onset
Secondary outcome [4] 408721 0
ankle plantarflexor muscle strength
Tested using manual muscle testing
Timepoint [4] 408721 0
The muscle strength will be measured on 1,2,3,4,8,12 and 26 weeks following stroke onset
Secondary outcome [5] 409639 0
For individuals who score 0 or 1 on manual muscle test for hip extensor muscle strength only, EMG will then be used on the same to determine muscle activity
Timepoint [5] 409639 0
EMG readings if indicated will be measured on 1,2,3,4,8,12 and 26 weeks following stroke onset
Secondary outcome [6] 409668 0
For individuals who score 0 or 1 on manual muscle test for knee extensor muscle strength only, EMG will then be used on the same to determine muscle activity
Timepoint [6] 409668 0
EMG readings if indicated will be measured on 1,2,3,4,8,12 and 26 weeks following stroke onset
Secondary outcome [7] 409669 0
For individuals who score 0 or 1 on manual muscle test for ankle dorsiflexor muscle strength only, EMG will then be used on the same to determine muscle activity
Timepoint [7] 409669 0
EMG readings if indicated will be measured on 1,2,3,4,8,12 and 26 weeks following stroke onset
Secondary outcome [8] 409670 0
For individuals who score 0 or 1 on manual muscle test for ankle plantarflexor muscle strength only, EMG will then be used on the same to determine muscle activity
Timepoint [8] 409670 0
EMG readings if indicated will be measured on 1,2,3,4,8, 12 and 26 weeks following stroke onset

Eligibility
Key inclusion criteria
Adult stroke survivors within 2 weeks of stroke
Unable to walk independently (defined as Functional Ambulation Category (0-5) of less than or equal to 3)
Able to give written or oral informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A history of clinical conditions affecting mobility
A progressive neurological disease
An inability to understand verbal or demonstrated instructions to perform outcome measures
Medical contraindications to perform outcome measures
Likely discharge destination outside of Sydney Metropolitan area

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
A Mixed effect model with cluster robust standard errors will be used to analyse the data collected in this study. This model will examine how results of manual muscle testing and EMG studies will predict future walking ability as measured with walking speed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/07/2022
Actual
14/09/2022
Date of last participant enrolment
Anticipated
29/11/2024
Actual
Date of last data collection
Anticipated
31/05/2025
Actual
Sample size
Target
175
Accrual to date
73
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 21958 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 21959 0
St George Hospital - Kogarah
Recruitment hospital [3] 26563 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [4] 26564 0
Concord Repatriation Hospital - Concord
Recruitment hospital [5] 26565 0
Balmain Hospital - Balmain
Recruitment postcode(s) [1] 37052 0
2031 - Randwick
Recruitment postcode(s) [2] 37053 0
2217 - Kogarah
Recruitment postcode(s) [3] 42605 0
2050 - Camperdown
Recruitment postcode(s) [4] 42606 0
2139 - Concord
Recruitment postcode(s) [5] 42607 0
2041 - Balmain

Funding & Sponsors
Funding source category [1] 310996 0
University
Name [1] 310996 0
Australian Catholic University
Country [1] 310996 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
Level 6, 33 Berry Street
North Sydney
NSW
2060
Country
Australia
Secondary sponsor category [1] 312307 0
None
Name [1] 312307 0
Address [1] 312307 0
Country [1] 312307 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310550 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 310550 0
Room G7, Level 2,
Clinical Science Building
Prince of Wales Hospital,
320-346 Barker Street
Randwick, NSW
2031
Ethics committee country [1] 310550 0
Australia
Date submitted for ethics approval [1] 310550 0
25/11/2021
Approval date [1] 310550 0
15/12/2021
Ethics approval number [1] 310550 0
2021/ETH11829

Summary
Brief summary
In this study, we aim to determine the relationship between clinical measures of early muscle activity in the affected lower limb and future walking speed for stroke survivors who were initially unable to walk. Our hypothesis is that muscle strength recovery will be a significant predictor of future walking speed.

The muscle group we will measure include muscles that extend the hip and knees as well as the muscles that move the ankle joints. We will measure muscle strength manually and using surface electromyography to 'listen' for any muscle activity present.

We will measure walking speed once the participant is able to walk independently. These measurements will be taken at 1,2,3,4,8,12 and 26 weeks post stroke.

Trial website
Trial related presentations / publications
Public notes
The ability to achieve community ambulating walking speed is important for stroke survivors. Current predictors for walking recovery post stroke dichotomises walking to whether a person achieves walking independence or not. For stroke survivors unable to walk initially post stroke, approximately 60% can walk independently after rehabilitation. Despite this, around half of the stroke survivors walking independently cannot access the community due to reduced walking speed. Therefore, prediction for walking ability after stroke should focus on walking speed.

Clinical measures of muscle strength and muscle activity have been shown to be an effective predictor for recovery in the upper limb after stroke. This has provided clinicians a framework to predict upper limb recovery and hence guide rehabilitation programs for stroke survivors with very weak upper limbs after a stroke. However, this level of specificity does not exist for the prediction of walking ability after stroke.

Predicting walking ability after stroke, particularly for initially non-ambulant stroke survivors, remains challenging. Prediction models using clinical measures of muscle strength and muscle activity that could be validated to predict walking ability would be of use to clinicians and enhance translation into clinical practice.

Clinical measures of muscle strength include surface electromyography (sEMG) and manual muscle testing. sEMG can be used to ascertain the presence of electrical activity in muscles including those that do not have any visible muscle contraction. It is also readily accessible for clinicians and easy to use. sEMG can be used to provide quantitative metrics for muscle activity and can have prognostic value for predicting future function. Manual muscle testing is typically used by physiotherapists to quantify muscle strength in stroke survivors. However, the combination of the presence of muscle activity through the sEMG and muscle strength to predict future walking ability in initially non-ambulant stroke survivors has not been studied.

Therefore, the objectives for this study are to:
1. Determine the relationship between clinical measures of early muscle activity (including sEMG and muscle strength) and walking ability at 6 months in initially non-ambulant stroke survivors?
a. Understand which time point best predicts walking ability
b. Does the rate of recovery of muscle strength predict walking ability?

Contacts
Principal investigator
Name 118046 0
Ms Zheng Cao
Address 118046 0
Faculty of Health Sciences
Australian Catholic University
Level 6, 33 Berry Street
North Sydney NSW
2060
Country 118046 0
Australia
Phone 118046 0
+61 425270056
Fax 118046 0
Email 118046 0
[email protected]
Contact person for public queries
Name 118047 0
Zheng Cao
Address 118047 0
Faculty of Health Sciences
Australian Catholic University
Level 6, 33 Berry Street
North Sydney NSW
2060
Country 118047 0
Australia
Phone 118047 0
+61 425270056
Fax 118047 0
Email 118047 0
[email protected]
Contact person for scientific queries
Name 118048 0
Zheng Cao
Address 118048 0
Faculty of Health Sciences
Australian Catholic University
Level 6, 33 Berry Street
North Sydney NSW
2060
Country 118048 0
Australia
Phone 118048 0
+61 425270056
Fax 118048 0
Email 118048 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?
Walking speed
Muscle strength and EMG activity after stroke
When will data be available (start and end dates)?
Data will be available from July 2024 (anticipated data completion) and
there will be no end date
Available to whom?
Scientific community and stroke survivors
Available for what types of analyses?
any purpose
How or where can data be obtained?
contact principal investigator
Zheng Cao
email: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15702Ethical approval    383747-(Uploaded-06-04-2022-14-45-24)-Study-related document.pdf



Results publications and other study-related documents

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