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Trial registered on ANZCTR


Registration number
ACTRN12619001123134p
Ethics application status
Not yet submitted
Date submitted
25/07/2019
Date registered
12/08/2019
Date last updated
12/08/2019
Date data sharing statement initially provided
12/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Quantifying spasticity using a robotic device: the QUASAR study
Scientific title
Evaluating the test-retest reliability of a robotic device for assessing spasticity in the elbow flexors of adult chronic stroke patients
Secondary ID [1] 298836 0
Nil known
Universal Trial Number (UTN)
U1111-1237-5374
Trial acronym
QuASAR study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 313789 0
Condition category
Condition code
Stroke 312203 312203 0 0
Haemorrhagic
Stroke 312204 312204 0 0
Ischaemic

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study aims to evaluate the test-retest reliability of a robotic device to accurately identify at what velocity spasticity is triggered, and to determine the concurrent validity of the robotic device with the most commonly used clinical assessments for spasticity, the modified Tardieu Scale and the Modified Ashworth Scale.
Patients will undertake two trials with the robotic device (described below) and clinical measures of spasticity. Each trial will last 20 minutes and the patient will have a 10 minute break between trials. A maximum time of 60 minutes will be allocated to the trial.
a) Robotic device description - this study uses the M2 (Fourier Intelligence), a robotic device that is commercially available and registered with TGA. The device is a planar manipulandum which attaches to the hand of the patient with forearm support. As such it is able to passively move the participant's hand / arm in the transverse plane. The device comes up with a user interface on a computer screen which includes a number of options such as rehabilitation activities and assessment options.
b) Administration - an AHPRA registered occupational therapist with significant expertise in neurological rehabilitation will be responsible for conducting the clinical scales and setting the patient up on the M2 for the robotic measures. An engineer will be present during the robotic measure phase.
c) Mode of delivery - individual
d) Velocity - the robotic device will passively flex and extend the patient's elbow through a maximum range of 80 degrees. Patients commence with elbow flexed to 90 degrees (shortened flexors) and the robot passively extends at a velocity of 10 cm per second. This procedure is completed at increasing velocities of 10 cm per second up to a maximum of 80 cm per second i.e. velocities will be 10 cm/s, 20 cm/s, 30 cm/s, 40 cm/s, 50 cm/s, 60 cm/s, 70 cm/s and 80 cm/s. The trial ceases when the patient exhibits a resistance force at higher than 80 Newton.
Intervention code [1] 315103 0
Diagnosis / Prognosis
Comparator / control treatment
This study aims to compare the robotics evaluation of spasticity with current commonly used clinical scales - the Modified Ashworth Scale and the Modified Tardieu Scale
Control group
Active

Outcomes
Primary outcome [1] 320831 0
Spasticity assessed and quantified using the robotic device measured as the maximal resistance force at a given velocity.
Timepoint [1] 320831 0
Measured immediately following undertaking each trial in the robotic device.
Primary outcome [2] 321014 0
The test-retest reliability of the robotic device measurement of spasticity. Spasticity measurement is defined a force-speed regression coefficient (speed dependant component of the reaction force). The test-retest will be assessed as a correlation (Pearson) coefficient.
Timepoint [2] 321014 0
At completion of data collection for all subjects
Secondary outcome [1] 372990 0
Spasticity as assessed using the Modified Tardieu Scale
Timepoint [1] 372990 0
Measured prior to undertaking each trial in the robotic device
Secondary outcome [2] 373364 0
Spasticity as assessed using the Modified Ashworth Scale
Timepoint [2] 373364 0
Measured prior to undertaking each trial in the robotic device

Eligibility
Key inclusion criteria
Hemiparesis due to a unilateral single clinical stroke
Spasticity in the elbow flexors
Able to give informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Co-morbid neurological conditions
Recent <6 months pharmacological treatment for spasticity including botulinum toxin and baclofen
Painful shoulder
Significant upper limb pathology e.g. osteoarthritis
Inability to follow a single-stage command
Presence of contractures in the affected upper limb

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sample size - previously published literature on this topic have typically used smaller sample sizes (e.g. up to 12 subjects). However, according to Zou (2011), a statistical analysis that uses intraclass correlation coefficients with 80% reliability over two observations (trials), requires a sample size of 35.
Statistical methods - this study will use the following statistical analysis methods:
1. Test retest reliability of the robotic measures - Pearson correlation coefficient
2. Agreement between robotic measures and MAS and Tardieu scales: Spearman's correlation coefficients
3. Spasticity dependence to velocity: to determine the evolution of resistance force with velocity, two models (linear and exponential) will be fitted to the robotic measures and evaluated through their correlation coefficients

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14313 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 27311 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 303385 0
University
Name [1] 303385 0
University of Melbourne
Address [1] 303385 0
Parkville Vic 3010
Country [1] 303385 0
Australia
Funding source category [2] 303450 0
Hospital
Name [2] 303450 0
Royal Melbourne Hospital
Address [2] 303450 0
Grattan Street Parkville Vic 3050
Country [2] 303450 0
Australia
Primary sponsor type
Hospital
Name
Melbourne Health
Address
Royal Melbourne Hospital
300 Grattan Street
Parkville, Vic, 3050
Country
Australia
Secondary sponsor category [1] 303421 0
University
Name [1] 303421 0
University of Melbourne
Address [1] 303421 0
School of Mechanical Engineering
Grattan Street
Parkville, Vic, 3010
Country [1] 303421 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 303915 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 303915 0
Office for Research
Level 2 South West
300 Grattan Street
Parkville, Vic, 3050
Ethics committee country [1] 303915 0
Australia
Date submitted for ethics approval [1] 303915 0
30/08/2019
Approval date [1] 303915 0
Ethics approval number [1] 303915 0

Summary
Brief summary
Spasticity is a common sequelae following stroke with prevalence rates of 30-80%. Patients experiencing upper limb spasticity report reduced quality of life secondary to difficulties using their arm for daily tasks and pain.
Valid and reliable assessments for spasticity are critical for the selection and evaluation of treatments. Clinical scales are the most common method for assessing upper limb spasticity following a stroke, and include the Modified Ashworth Scale (MAS) and the Modified Tardieu Scale (MTS).
More recently, robotic devices and information technology have been found to be safe and effective in increasing the efficiency of care, including objectively measuring impairments. We hypothesise that a robotic device will provide a more accurate and reliable measure of spasticity than existing clinical scales.
This study aims to compare reliability between the robotic device and the two clinical measures, the MAS and MTS, in assessing spasticity in the elbow flexors of stroke survivors.
Participants’ affected upper limb will be passively moved from flexion to extension using different speeds. This study will take place at the Royal Melbourne Hospital, in Australia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95234 0
Dr Marlena Klaic
Address 95234 0
Allied Health Department
Royal Melbourne Hospital
300 Grattan Street
Parkville, Vic, 3050
Country 95234 0
Australia
Phone 95234 0
+61 39342 7711
Fax 95234 0
+61 39342 8440
Email 95234 0
marlena.klaic@mh.org.au
Contact person for public queries
Name 95235 0
Dr Marlena Klaic
Address 95235 0
Allied Health Department
Royal Melbourne Hospital
300 Grattan Street
Parkville, Vic, 3050
Country 95235 0
Australia
Phone 95235 0
+61 39342 7711
Fax 95235 0
+61 39342 8440
Email 95235 0
marlena.klaic@mh.org.au
Contact person for scientific queries
Name 95236 0
Dr Vincent Crocher
Address 95236 0
University of Melbourne
School of Mechanical Engineering
Grattan Street
Parkville, Vic, 3010
Country 95236 0
Australia
Phone 95236 0
+61 434394068
Fax 95236 0
Email 95236 0
vincent.crocher@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As per ethical requirements from the organisation and university, no individual data will be provided due to the potential for breaching confidentiality of study participants.
What supporting documents are/will be available?
No other documents available
Summary results
No Results