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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
Scientific title
Objective measurement of muscle co-contraction pre-and post-Botulinum Toxin-A injection in adults with focal spasticity
Secondary ID [1] 310571 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 331424 0
Traumatic Brain Injuries 331425 0
Acquired Brain Injuries 331426 0
Cerebral Palsy 331427 0
Multiple Sclerosis 331428 0
Condition category
Condition code
Stroke 328167 328167 0 0
Haemorrhagic
Neurological 328168 328168 0 0
Other neurological disorders
Neurological 328169 328169 0 0
Multiple sclerosis
Neurological 328170 328170 0 0
Neurodegenerative diseases
Stroke 328171 328171 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 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.
Intervention code [1] 326975 0
Not applicable
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.
Control group
Active

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,
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.
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,
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.
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,
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.
Secondary outcome [1] 426627 0
Muscle spasticity assessed using the Modified Ashworth Scale
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.
Secondary outcome [2] 426628 0
Sensory perception assessed using 2-point discrimination
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.
Secondary outcome [3] 426629 0
Upper limb function assessed using the Action Research Arm Test (ARAT)
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)
Secondary outcome [4] 426630 0
Goal Achievement assessed using Goal Attainment Scaling (GAS)
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.
Secondary outcome [5] 426631 0
Patient reported outcome of clinical benefit assessed using the Global Assessment of Benefit (GAB)
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.
Secondary outcome [6] 427679 0
Muscle spasticity assessed using Modified Tardieu Scale
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.
Secondary outcome [7] 427680 0
Balance assessed using Berg Balance Scale
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.
Secondary outcome [8] 427681 0
Sensory perception assessed using proprioception (ie, threshold to detection of passive motion)
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.
Secondary outcome [9] 427682 0
Upper limb function assessed using the Functional Reach test
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.
Secondary outcome [10] 427683 0
Upper limb function assessed using the Upper Limb Performance Analysis (ULPA)
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.
Secondary outcome [11] 427684 0
Lower limb function assessed using the Timed-up-and-go assessment
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.
Secondary outcome [12] 427685 0
Patient reported upper limb function assessed using the Arm Activity Measure (ARMA)
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)
Secondary outcome [13] 427686 0
Patient reported lower limb function assessed using the Leg Activity Measure (LEGA)
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.
Secondary outcome [14] 427687 0
Patient reported disability assessed using the Patient Disability Scale (PDS)
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.
Secondary outcome [15] 427688 0
Carer/family reported care burden assessed using the Carer Burden Scale (CBS)
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.
Secondary outcome [16] 427689 0
Patient reported pain assessed using a Visual Analogue Scale (VAS)
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.
Secondary outcome [17] 427690 0
Patient reported sleep patterns assessed using self-reported sleep duration and number of wakes per night.
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.
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,
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.
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,
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.
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,
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.

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/11/2023
Actual
Date of last participant enrolment
Anticipated
14/04/2025
Actual
Date of last data collection
Anticipated
25/05/2025
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 41321 0
2145 - Westmead
Recruitment postcode(s) [2] 41322 0
2170 - Liverpool
Recruitment postcode(s) [3] 41323 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 314780 0
Commercial sector/Industry
Name [1] 314780 0
Abbvie Pty Ltd
Country [1] 314780 0
Australia
Primary sponsor type
Individual
Name
A/Prof Ian Baguley
Address
Brain Injury Rehabilitation Service, Westmead Hospital, Hawkesbury Rd, Westmead NSW 2145,
Country
Australia
Secondary sponsor category [1] 316766 0
Individual
Name [1] 316766 0
Dr Hannah Barden
Address [1] 316766 0
Brain Injury Rehabilitation Service, Westmead Hospital, Hawkesbury Rd, Westmead NSW 2145,
Country [1] 316766 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313789 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 313789 0
Ethics committee country [1] 313789 0
Australia
Date submitted for ethics approval [1] 313789 0
14/04/2023
Approval date [1] 313789 0
14/09/2023
Ethics approval number [1] 313789 0

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

Contacts
Principal investigator
Name 129354 0
A/Prof Ian Baguley
Address 129354 0
Brain Injury Rehabilitation Service, Westmead Hospital, PO Box 533, Wentworthville, NSW 2145
Country 129354 0
Australia
Phone 129354 0
+61 02 8890 7941
Fax 129354 0
Email 129354 0
[email protected]
Contact person for public queries
Name 129355 0
Hannah Barden
Address 129355 0
Brain Injury Rehabilitation Service, Westmead Hospital, PO Box 533, Wentworthville, NSW 2145
Country 129355 0
Australia
Phone 129355 0
+61 02 88907941
Fax 129355 0
Email 129355 0
[email protected]
Contact person for scientific queries
Name 129356 0
Ian Baguley
Address 129356 0
Brain Injury Rehabilitation Service, Westmead Hostpial, PO Box 533, Wentworthville, NSW 2145
Country 129356 0
Australia
Phone 129356 0
+61 02 8890 7941
Fax 129356 0
Email 129356 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
In line with our Ethics approval individual participant data will not be available to maintain individual participant confidentiality.


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.