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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]

nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

stroke

muscle strength

Condition category

Condition code

Stroke

Haemorrhagic

Stroke

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]

Diagnosis / Prognosis

Comparator / control treatment

no control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

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]

Hip extensor muscle strength
Tested using manual muscle testing

Timepoint [1]

The muscle strength will be measured on 1,2,3,4,8,12 and 26 weeks following stroke onset

Secondary outcome [2]

knee extensor muscle strength
Tested using manual muscle testing

Timepoint [2]

The muscle strength will be measured on 1,2,3,4,8,12 and 26 weeks following stroke onset

Secondary outcome [3]

ankle dorsiflexor muscle strength
Tested using manual muscle testing

Timepoint [3]

The muscle strength will be measured on 1,2,3,4,8,12 and 26 weeks following stroke onset

Secondary outcome [4]

ankle plantarflexor muscle strength
Tested using manual muscle testing

Timepoint [4]

The muscle strength will be measured on 1,2,3,4,8,12 and 26 weeks following stroke onset

Secondary outcome [5]

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]

EMG readings if indicated will be measured on 1,2,3,4,8,12 and 26 weeks following stroke onset

Secondary outcome [6]

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]

EMG readings if indicated will be measured on 1,2,3,4,8,12 and 26 weeks following stroke onset

Secondary outcome [7]

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]

EMG readings if indicated will be measured on 1,2,3,4,8,12 and 26 weeks following stroke onset

Secondary outcome [8]

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]

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?

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

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Prince of Wales Hospital - Randwick

Recruitment hospital [2]

St George Hospital - Kogarah

Recruitment hospital [3]

Royal Prince Alfred Hospital - Camperdown

Recruitment hospital [4]

Concord Repatriation Hospital - Concord

Recruitment hospital [5]

Balmain Hospital - Balmain

Recruitment postcode(s) [1]

2031 - Randwick

Recruitment postcode(s) [2]

2217 - Kogarah

Recruitment postcode(s) [3]

2050 - Camperdown

Recruitment postcode(s) [4]

2139 - Concord

Recruitment postcode(s) [5]

2041 - Balmain

Funding & Sponsors

Funding source category [1]

University

Name [1]

Australian Catholic University

Address [1]

Level 6, 33 Berry Street
North Sydney
NSW
2060

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Eastern Sydney Local Health District HREC

Ethics committee address [1]

Room G7, Level 2,
Clinical Science Building
Prince of Wales Hospital, 
320-346 Barker Street
Randwick, NSW 
2031

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/11/2021

Approval date [1]

15/12/2021

Ethics approval number [1]

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

Ms Zheng Cao

Address

Faculty of Health Sciences
Australian Catholic University
Level 6, 33 Berry Street
North Sydney NSW
2060

Country

Australia

Phone

+61 425270056

Fax

[email protected]

Contact person for public queries

Name

Zheng Cao

Address

Faculty of Health Sciences
Australian Catholic University
Level 6, 33 Berry Street
North Sydney NSW
2060

Country

Australia

Phone

+61 425270056

Fax

[email protected]

Contact person for scientific queries

Name

Zheng Cao

Address

Faculty of Health Sciences
Australian Catholic University
Level 6, 33 Berry Street
North Sydney NSW
2060

Country

Australia

Phone

+61 425270056

Fax

[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.	Type	Citation	Link	Email	Other Details	Attachment
15702	Ethical approval					383747-(Uploaded-06-04-2022-14-45-24)-Study-related document.pdf

Results publications and other study-related documents

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No additional documents have been identified.

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