Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000937415
Ethics application status
Approved
Date submitted
17/02/2025
Date registered
29/08/2025
Date last updated
29/08/2025
Date data sharing statement initially provided
29/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of wearable E-Tattoo sensors for measuring muscle activity.
Scientific title
Evaluation of wearable integrated Electronic Tattoo (E-Tattoo) sensors for measuring muscle activity in stroke survivors with upper or lower limb spasticity.
Secondary ID [1] 313982 0
Nil
Universal Trial Number (UTN)
U1111-1319-1335
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 336703 0
traumatic brain injury 336704 0
multiple sclerosis 336705 0
Condition category
Condition code
Stroke 333202 333202 0 0
Ischaemic
Stroke 333203 333203 0 0
Haemorrhagic
Neurological 333204 333204 0 0
Multiple sclerosis
Neurological 333205 333205 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
At each appointment in the Spasticity Clinic, participants will be assessed as indicated below. The first appointment will be a baseline session, with a follow up session at the second appointment 6 weeks later.

Spasticity in the relevant muscle(s) will be measured using the Modified Ashworth Scale (MAS). This test is part of the standard assessment conducted by rehabilitation consultants in the Spasticity Clinic.

At the first and follow-up appointments in the Spasticity Clinic, the E-Tattoo electrodes will be applied by the physiotherapist to the skin overlying the spastic muscles and their antagonists. In the upper limb these will be the biceps (elbow flexor) and triceps (elbow extensor) muscles; in the lower limb, these will be the gastrocnemius, soleus (plantarflexors) and tibialis anterior (dorsiflexor) muscles. The electrodes will be worn for the duration of the Clinic appointment and during the relevant functional tests, and then removed before the participant leaves the Clinic.

Raw sEMG signals will be collected via a myRIO data acquisition system (National Instruments, Texas, US) at a sampling rate of 2000Hz. The data will be transferred to a computer for further processing. This includes signal processing, data segmentation, feature extraction, and classification, followed by pattern recognition to analyse muscle activity. The signal will be filtered using a bandpass filter between 20Hz and 450Hz. Additionally, a band-stop filter in the range of 49-51 Hz will be used to mitigate electrical and power frequency noise.

The functional tests will take approximately 30 minutes to complete.
Lower limb tasks: While wearing the sEMG electrodes, participants with lower limb spasticity will be assessed on the following tasks:
• Walking. Participants will wear research-grade APDM inertial sensors (APDM Inc. Portland OR) attached by straps to their sternum, sacrum and limbs and will walk a minimum of 100 metres along a corridor near the Clinic, using their usual gait aid, if required, to obtain spatiotemporal measures and kinematics of gait. Participants will be asked to walk without an ankle-foot orthosis if they normally wear one. Signals from the accelerometer on the sternum will be used to derive non-linear measures of gait, including the local divergence exponent (LDE), a measure of gait stability which has been shown by our group to be a much more sensitive measure of walking disability than traditional spatiotemporal measures.
• Timed Up and Go (TUG) test Participants will be asked to stand up from sitting on a chair, walk 3 metres, turn around, and walk back to sit on the chair. The task will be timed using a stopwatch.
• 5 times Sit-to-Stand (5xSTS): Participants will be asked to complete five consecutive sit-to-stand movements from a seated position. The task will be timed using a stopwatch.

Upper limb tasks: While wearing the sEMG electrodes, participants with upper limb spasticity will be assessed on the following tasks:
• Upper limb coordination task. Participants will have their arm fully supported on a table with their forearm resting on a sheepskin pad, with an accelerometer attached to the wrist. They will be asked to bend and straighten their elbow at a self-selected speed and also as fast as they can.
• 9-hole peg test (9HPT). The 9HPT is a brief, timed, standardised, quantitative test of finger dexterity. Participants will pick up pegs one by one from the container and place them in the empty holes in a board.
• Moving cones. Participants will be asked to grasp a cone from the table in front of them and move it forward as far as possible on the table. They will then return the cone to the starting position, and repeat this task another nine times. The test will be timed.

A semi-structured interview will be conducted with each participant immediately after each assessment timepoint to obtain information about their perceptions about the integrated E-Tattoo system. The interview will take 20 minutes.
Intervention code [1] 330567 0
Diagnosis / Prognosis
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340767 0
Coactivation Index between spastic muscles and their antagonists
Timepoint [1] 340767 0
Baseline and 6 weeks follow-up
Primary outcome [2] 340771 0
Participant perceptions of the integrated E-Tattoo system
Timepoint [2] 340771 0
Baseline and 6 weeks follow-up
Secondary outcome [1] 445042 0
Spasticity
Timepoint [1] 445042 0
Baseline and 6 weeks follow-up.
Secondary outcome [2] 445043 0
Gait stability in ambulant participants
Timepoint [2] 445043 0
Baseline and 6 weeks follow-up
Secondary outcome [3] 445044 0
Balance/mobility in ambulant participants
Timepoint [3] 445044 0
Baseline and 6 weeks follow-up.
Secondary outcome [4] 445045 0
Lower limb muscle power
Timepoint [4] 445045 0
Baseline and 6 weeks follow-up.
Secondary outcome [5] 445046 0
Finger dexterity in participants with upper limb spasticity
Timepoint [5] 445046 0
Baseline and 6 weeks follow-up.
Secondary outcome [6] 445047 0
Arm dexterity in participants with upper limb spasticity
Timepoint [6] 445047 0
Baseline and 6 weeks follow-up.
Secondary outcome [7] 450510 0
EMG characteristics at rest and during task performance
Timepoint [7] 450510 0
Baseline and 6 weeks follow-up.

Eligibility
Key inclusion criteria
• 18 years or over;
• Upper or lower limb spasticity (predominantly one or the other);
• The ability to walk 100 metres with or without a gait aid in participants with predominantly lower limb spasticity;
• Newly referred to the Spasticity Clinic at The Royal Park Rehabilitation Centre;
• Able to perform at least one of the functional tasks.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unable to provide informed consent;
• Unable to follow instructions.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
If participant numbers permit, paired t-tests in each subgroup (upper limb or lower limb spasticity) will be used to examine differences in:
• Time- and frequency-domain features of the sEMG signals [root mean square (RMS), average rectified activation amplitude and power spectrum] during the specific physical tasks and at rest, and between baseline and follow-up.
• The muscle coactivation index (COI) between elbow flexors and extensors or ankle plantarflexors and dorsiflexors (whichever is relevant) between baseline and follow-up.
Spearman correlation coefficients will be calculated to evaluate the correlation between sEMG variables, MAS score, and performance on the physical tests (LDE, TUG and 5xSTS for those with lower limb spasticity and the 9HPT and Cones for those with upper limb spasticity) at each timepoint.
Interviews will be recorded and transcribed. Thematic analysis will be conducted to identify and classify themes emerging from the interviews.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/11/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 43825 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 318484 0
University
Name [1] 318484 0
The University of Melbourne
Country [1] 318484 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 320877 0
None
Name [1] 320877 0
Address [1] 320877 0
Country [1] 320877 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317093 0
Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 317093 0
Ethics committee country [1] 317093 0
Australia
Date submitted for ethics approval [1] 317093 0
26/03/2025
Approval date [1] 317093 0
16/06/2025
Ethics approval number [1] 317093 0

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

Contacts
Principal investigator
Name 139974 0
Prof Mary Galea
Address 139974 0
Department of Medicine, The University of Melbourne, Grattan Street, Parkville, Victoria 3010,
Country 139974 0
Australia
Phone 139974 0
+61 3 83441947
Fax 139974 0
Email 139974 0
[email protected]
Contact person for public queries
Name 139975 0
Mary Galea
Address 139975 0
Department of Medicine, The University of Melbourne, Grattan Street, Parkville, Victoria 3010,
Country 139975 0
Australia
Phone 139975 0
+61 3 83441947
Fax 139975 0
Email 139975 0
[email protected]
Contact person for scientific queries
Name 139976 0
Mary Galea
Address 139976 0
Department of Medicine, The University of Melbourne, Grattan Street, Parkville, Victoria 3010,
Country 139976 0
Australia
Phone 139976 0
+61 3 83441947
Fax 139976 0
Email 139976 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Other researchers on request

Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
What individual participant data might be shared?
• Deidentified research data underlying the published results

What types of analyses could be done with individual participant data?
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
After study completion

To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Data will be maintained in a secure figshare repository, and may be accessed by contacting the Principal Investigator.: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.