Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12623001135606
Ethics application status
Approved
Date submitted
19/09/2023
Date registered
3/11/2023
Date last updated
3/11/2023
Date data sharing statement initially provided
3/11/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
Measurement of involuntary muscle contraction in adults with spasticity
Query!
Scientific title
Objective measurement of muscle co-contraction pre-and post-Botulinum Toxin-A injection in adults with focal spasticity
Query!
Secondary ID [1]
310571
0
Nil known
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Stroke
331424
0
Query!
Traumatic Brain Injuries
331425
0
Query!
Acquired Brain Injuries
331426
0
Query!
Cerebral Palsy
331427
0
Query!
Multiple Sclerosis
331428
0
Query!
Condition category
Condition code
Stroke
328167
328167
0
0
Query!
Haemorrhagic
Query!
Neurological
328168
328168
0
0
Query!
Other neurological disorders
Query!
Neurological
328169
328169
0
0
Query!
Multiple sclerosis
Query!
Neurological
328170
328170
0
0
Query!
Neurodegenerative diseases
Query!
Stroke
328171
328171
0
0
Query!
Ischaemic
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
False
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
Description of intervention(s) / exposure
This study will observe upper limb outcomes pre/post Botulinum Toxin-A injection as a part of routine clinical spasticity management for adults with focal spasticity. The gold standard for Botulinum Toxin-A injections has moved to individualised injection protocols based on self-selected goals, this means that the pattern of muscles injected, The dose injected into those muscles and the frequency of re-injection is determined an individual basis, The number of injection sites per muscle will be left to the discretion of the injecting physician, with a note made in the record as to what was done. In most situations maximum overall dose will be 400 BOTOX units, however, there will be some people that have in excess of this based on past clinical experience. Observations will focus on change in functional upper limb use, immediately prior to (<=1 week) and 4-6 weeks after injection for one or 2 treatment cycles. Patients will be injected with BOTOX based on clinical need and irrespective of their willingness to be enrolled as a participant in the study.
Query!
Intervention code [1]
326975
0
Not applicable
Query!
Comparator / control treatment
A control group of healthy adults will be recruited. They will not be undergoing an active intervention and will only be assessed on the functional upper limb measures.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
336046
0
Maximum force generation data from Dynamic Computerised Dynamometry (DCD) for both the injected and non-injected upper limbs will be collected per published protocols and analysed offline,
Query!
Assessment method [1]
336046
0
Query!
Timepoint [1]
336046
0
<=1 week pre-injection
4-6 weeks post Botulinum Toxin-A injection
for a maximum of 2 treatment cycles over a 6-12 month period.
Query!
Primary outcome [2]
336462
0
Minimum force generation data from Dynamic Computerised Dynamometry (DCD) for both the injected and non-injected upper limbs will be collected per published protocols and analysed offline,
Query!
Assessment method [2]
336462
0
Query!
Timepoint [2]
336462
0
<=1 week pre-injection
4-6 weeks post Botulinum Toxin-A injection
for a maximum of 2 treatment cycles over a 6-12 month period.
Query!
Primary outcome [3]
336463
0
Contraction Velocity data from Dynamic Computerised Dynamometry (DCD) for both the injected and non-injected upper limbs will be collected per published protocols and analysed offline,
Query!
Assessment method [3]
336463
0
Query!
Timepoint [3]
336463
0
<=1 week pre-injection
4-6 weeks post Botulinum Toxin-A injection
for a maximum of 2 treatment cycles over a 6-12 month period.
Query!
Secondary outcome [1]
426627
0
Muscle spasticity assessed using the Modified Ashworth Scale
Query!
Assessment method [1]
426627
0
Query!
Timepoint [1]
426627
0
<=1 week pre-injection
4-6 weeks post Botulinum Toxin-A injection
for a maximum of 2 treatment cycles over a 6-12 month period.
Query!
Secondary outcome [2]
426628
0
Sensory perception assessed using 2-point discrimination
Query!
Assessment method [2]
426628
0
Query!
Timepoint [2]
426628
0
<=1 week pre-injection
4-6 weeks post Botulinum Toxin-A injection
for a maximum of 2 treatment cycles over a 6-12 month period.
Query!
Secondary outcome [3]
426629
0
Upper limb function assessed using the Action Research Arm Test (ARAT)
Query!
Assessment method [3]
426629
0
Query!
Timepoint [3]
426629
0
<=1 week pre-injection
4-6 weeks post Botulinum Toxin-A injection
for a maximum of 2 treatment cycles over a 6-12 month period.
Healthy Controls will be assessed at 2 equivalent times points (ie, Time 1 and then Time 2 approximately 4-6 weeks after Time 1)
Query!
Secondary outcome [4]
426630
0
Goal Achievement assessed using Goal Attainment Scaling (GAS)
Query!
Assessment method [4]
426630
0
Query!
Timepoint [4]
426630
0
<=1 week pre-injection
4-6 weeks post Botulinum Toxin-A injection
for a maximum of 2 treatment cycles over a 6-12 month period.
Query!
Secondary outcome [5]
426631
0
Patient reported outcome of clinical benefit assessed using the Global Assessment of Benefit (GAB)
Query!
Assessment method [5]
426631
0
Query!
Timepoint [5]
426631
0
<=1 week pre-injection
4-6 weeks post Botulinum Toxin-A injection
for a maximum of 2 treatment cycles over a 6-12 month period.
Query!
Secondary outcome [6]
427679
0
Muscle spasticity assessed using Modified Tardieu Scale
Query!
Assessment method [6]
427679
0
Query!
Timepoint [6]
427679
0
<=1 week pre-injection
4-6 weeks post Botulinum Toxin-A injection
for a maximum of 2 treatment cycles over a 6-12 month period.
Query!
Secondary outcome [7]
427680
0
Balance assessed using Berg Balance Scale
Query!
Assessment method [7]
427680
0
Query!
Timepoint [7]
427680
0
<=1 week pre-injection
4-6 weeks post Botulinum Toxin-A injection
for a maximum of 2 treatment cycles over a 6-12 month period.
Query!
Secondary outcome [8]
427681
0
Sensory perception assessed using proprioception (ie, threshold to detection of passive motion)
Query!
Assessment method [8]
427681
0
Query!
Timepoint [8]
427681
0
<=1 week pre-injection
4-6 weeks post Botulinum Toxin-A injection
for a maximum of 2 treatment cycles over a 6-12 month period.
Query!
Secondary outcome [9]
427682
0
Upper limb function assessed using the Functional Reach test
Query!
Assessment method [9]
427682
0
Query!
Timepoint [9]
427682
0
<=1 week pre-injection
4-6 weeks post Botulinum Toxin-A injection
for a maximum of 2 treatment cycles over a 6-12 month period.
Query!
Secondary outcome [10]
427683
0
Upper limb function assessed using the Upper Limb Performance Analysis (ULPA)
Query!
Assessment method [10]
427683
0
Query!
Timepoint [10]
427683
0
<=1 week pre-injection
4-6 weeks post Botulinum Toxin-A injection
for a maximum of 2 treatment cycles over a 6-12 month period.
The ULPA will not be completed with Healthy Controls due to marked ceiling effects in this measure for this group.
Query!
Secondary outcome [11]
427684
0
Lower limb function assessed using the Timed-up-and-go assessment
Query!
Assessment method [11]
427684
0
Query!
Timepoint [11]
427684
0
<=1 week pre-injection
4-6 weeks post Botulinum Toxin-A injection
for a maximum of 2 treatment cycles over a 6-12 month period.
Query!
Secondary outcome [12]
427685
0
Patient reported upper limb function assessed using the Arm Activity Measure (ARMA)
Query!
Assessment method [12]
427685
0
Query!
Timepoint [12]
427685
0
<=1 week pre-injection
4-6 weeks post Botulinum Toxin-A injection
for a maximum of 2 treatment cycles over a 6-12 month period.
Healthy Controls will be assessed at 2 equivalent times points (ie, Time 1 and then Time 2 approximately 4-6 weeks after Time 1)
Query!
Secondary outcome [13]
427686
0
Patient reported lower limb function assessed using the Leg Activity Measure (LEGA)
Query!
Assessment method [13]
427686
0
Query!
Timepoint [13]
427686
0
<=1 week pre-injection
4-6 weeks post Botulinum Toxin-A injection
for a maximum of 2 treatment cycles over a 6-12 month period.
Query!
Secondary outcome [14]
427687
0
Patient reported disability assessed using the Patient Disability Scale (PDS)
Query!
Assessment method [14]
427687
0
Query!
Timepoint [14]
427687
0
<=1 week pre-injection
4-6 weeks post Botulinum Toxin-A injection
for a maximum of 2 treatment cycles over a 6-12 month period.
Query!
Secondary outcome [15]
427688
0
Carer/family reported care burden assessed using the Carer Burden Scale (CBS)
Query!
Assessment method [15]
427688
0
Query!
Timepoint [15]
427688
0
<=1 week pre-injection
4-6 weeks post Botulinum Toxin-A injection
for a maximum of 2 treatment cycles over a 6-12 month period.
Query!
Secondary outcome [16]
427689
0
Patient reported pain assessed using a Visual Analogue Scale (VAS)
Query!
Assessment method [16]
427689
0
Query!
Timepoint [16]
427689
0
<=1 week pre-injection
4-6 weeks post Botulinum Toxin-A injection
for a maximum of 2 treatment cycles over a 6-12 month period.
Query!
Secondary outcome [17]
427690
0
Patient reported sleep patterns assessed using self-reported sleep duration and number of wakes per night.
Query!
Assessment method [17]
427690
0
Query!
Timepoint [17]
427690
0
<=1 week pre-injection
4-6 weeks post Botulinum Toxin-A injection
for a maximum of 2 treatment cycles over a 6-12 month period.
Query!
Secondary outcome [18]
428483
0
Relaxation Velocity data from Dynamic Computerised Dynamometry (DCD) for both the injected and non-injected upper limbs will be collected per published protocols and analysed offline as a primary outcome measure,
Query!
Assessment method [18]
428483
0
Query!
Timepoint [18]
428483
0
<=1 week pre-injection
4-6 weeks post Botulinum Toxin-A injection
for a maximum of 2 treatment cycles over a 6-12 month period.
Query!
Secondary outcome [19]
428484
0
Voluntary Work data from Dynamic Computerised Dynamometry (DCD) for both the injected and non-injected upper limbs will be collected per published protocols and analysed offline as a primary outcome measure,
Query!
Assessment method [19]
428484
0
Query!
Timepoint [19]
428484
0
<=1 week pre-injection
4-6 weeks post Botulinum Toxin-A injection
for a maximum of 2 treatment cycles over a 6-12 month period.
Query!
Secondary outcome [20]
428485
0
Involuntary Work data from Dynamic Computerised Dynamometry (DCD) for both the injected and non-injected upper limbs will be collected per published protocols and analysed offline as a primary outcome measure,
Query!
Assessment method [20]
428485
0
Query!
Timepoint [20]
428485
0
<=1 week pre-injection
4-6 weeks post Botulinum Toxin-A injection
for a maximum of 2 treatment cycles over a 6-12 month period.
Query!
Eligibility
Key inclusion criteria
Clinical Group:
• Ability to understand verbal instructions in English
• Motor overactivity resulting from an UMN syndrome of greater than 3 months duration
• Predominately unilateral disability.
• Presence of active grip strength in the most affected upper limb (a minimum of 0.75kg of force)
* People who are receiving Botulinum Toxin-A injections as part of their spasticity management.
Control group
• Age 18+ years
• Ability to understand verbal instructions in English
• Available for two assessments
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
• Other causes of upper limb weakness including non-neurological pain, rheumatological conditions, lower motor neuron lesions, etc.
• Inadequate ability to understand and follow instructions, such as language barriers or inadequate voluntary motor control.
• People with spasticity who are not being offered OnabotulinumtoxinA injections as a clinical treatment.
* People with a known contraindication to OnabotulinumtoxinA e.g., Eaton-Lambert syndrome, pregnancy, hypersensitivity etc.
Control group
• Self-reported neurological impairment
• Self-reported acute or chronic arm injury or impairment
Query!
Study design
Purpose
Natural history
Query!
Duration
Longitudinal
Query!
Selection
Convenience sample
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Summary statistics of all demographic, clinical, and outcome variables will be reported at baseline and after treatment as appropriate for the data type. To look at the differences between groups and pre/post Botulinum Toxin A injection for clinical participants sample means and proportions will be tested by the relevant test’s multivariate counterpart: one-way ANOVA, Kruskal-Wallis rank sum, or chi-squared tests, as appropriate. Change in functional upper limb outcomes (by DCD measurements) following Botulinum Toxin A injection will be assessed using univariate and multivariate linear mixed effects models.
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
23/11/2023
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
14/04/2025
Query!
Actual
Query!
Date of last data collection
Anticipated
25/05/2025
Query!
Actual
Query!
Sample size
Target
90
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment postcode(s) [1]
41321
0
2145 - Westmead
Query!
Recruitment postcode(s) [2]
41322
0
2170 - Liverpool
Query!
Recruitment postcode(s) [3]
41323
0
2217 - Kogarah
Query!
Funding & Sponsors
Funding source category [1]
314780
0
Commercial sector/Industry
Query!
Name [1]
314780
0
Abbvie Pty Ltd
Query!
Address [1]
314780
0
Level 7, 241 O'Riordan St, Mascot NSW 2020
Query!
Country [1]
314780
0
Australia
Query!
Primary sponsor type
Individual
Query!
Name
A/Prof Ian Baguley
Query!
Address
Brain Injury Rehabilitation Service, Westmead Hospital, Hawkesbury Rd, Westmead NSW 2145,
Query!
Country
Australia
Query!
Secondary sponsor category [1]
316766
0
Individual
Query!
Name [1]
316766
0
Dr Hannah Barden
Query!
Address [1]
316766
0
Brain Injury Rehabilitation Service, Westmead Hospital, Hawkesbury Rd, Westmead NSW 2145,
Query!
Country [1]
316766
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
313789
0
Western Sydney Local Health District Human Research Ethics Committee
Query!
Ethics committee address [1]
313789
0
Westmead Hospital Cnr Hawkesbury & Darcy Rds Westmead NSW 2145
Query!
Ethics committee country [1]
313789
0
Australia
Query!
Date submitted for ethics approval [1]
313789
0
14/04/2023
Query!
Approval date [1]
313789
0
14/09/2023
Query!
Ethics approval number [1]
313789
0
Query!
Summary
Brief summary
This study aims first, to objectively measure co-contraction phenomena during a functionally based repeated grasp and release task in adults with UMN syndrome resulting from a neurological diagnosis. Second, to demonstrate the relationship/impact of abnormal muscle co-contraction on everyday function. Finally, this study aims to objectively measure change in maladaptive co-contraction following OnabotulinumtoxinA injection. This study will contribute to the body of knowledge regarding the pathophysiology of maladaptive muscle co-contraction and explore the impact of co-contraction on everyday function.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
129354
0
A/Prof Ian Baguley
Query!
Address
129354
0
Brain Injury Rehabilitation Service, Westmead Hospital, PO Box 533, Wentworthville, NSW 2145
Query!
Country
129354
0
Australia
Query!
Phone
129354
0
+61 02 8890 7941
Query!
Fax
129354
0
Query!
Email
129354
0
[email protected]
Query!
Contact person for public queries
Name
129355
0
Dr Hannah Barden
Query!
Address
129355
0
Brain Injury Rehabilitation Service, Westmead Hospital, PO Box 533, Wentworthville, NSW 2145
Query!
Country
129355
0
Australia
Query!
Phone
129355
0
+61 02 88907941
Query!
Fax
129355
0
Query!
Email
129355
0
[email protected]
Query!
Contact person for scientific queries
Name
129356
0
A/Prof Ian Baguley
Query!
Address
129356
0
Brain Injury Rehabilitation Service, Westmead Hostpial, PO Box 533, Wentworthville, NSW 2145
Query!
Country
129356
0
Australia
Query!
Phone
129356
0
+61 02 8890 7941
Query!
Fax
129356
0
Query!
Email
129356
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
In line with our Ethics approval individual participant data will not be available to maintain individual participant confidentiality.
Query!
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.
Download to PDF