Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000821594
Ethics application status
Approved
Date submitted
24/06/2015
Date registered
10/08/2015
Date last updated
10/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Management of ankle deformity after acquired brain injury
Scientific title
Effectiveness of combining serial casting and botulinum toxin for the management of ankle contractures after traumatic brain injury: a randomised controlled study
Secondary ID [1] 286551 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acquired brain injury admitted for sub-acute rehabilitation 294796 0
contracture 294797 0
Condition category
Condition code
Physical Medicine / Rehabilitation 295072 295072 0 0
Physiotherapy
Neurological 295073 295073 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group receives intervention treatment in addition to usual care. Botulinum toxin will be injected into calf muscles which may include soleus, gastronemius, flexor hallucis longer and flexor digitorium longus. Botulinum toxin injection may also be injected into tibialis posterior where necessary. The injections will be administered by a sole person (the Director of the Brain Injury Unit) with electrical stimulation or sonographic guidance. The dose of botulinum toxin will vary depending on number of muscles needing injections but will be within the recommended maximum dose of 400ml. Serial casting will be commenced within a few days. Cast will be applied to the ankle by physiotherapists. The duration of casting and number of cast applied may vary based on the participants’ responses to casting. After completion of casting, a customised ankle splint will be used immediately. The splint will be worn 24 hours a day for the initial 2 weeks during which the splint will only be removed for hygiene reasons and therapy. Thereafter ongoing monitoring will be conducted and the splinting time will be maintained or reduced depending on the progress of the participants. The splint will be applied by physiotherapists, nursing staff or physiotherapy assistants as directed by the treating physiotherapists. The participants’ tolerance to splinting and skin condition will be closely monitored. This treatment program simulates the current clinical practice of a Brain Injury Unit in Sydney. Participants in the control group will be placed on a wait list for 6 weeks during which they receive no botulinum toxin, splinting and passive stretch-based interventions for the ankle. Thereafter, they receive the same treatment as the intervention group. Diaries will be used to record all interventions and adverse events.
Intervention code [1] 291656 0
Rehabilitation
Intervention code [2] 292499 0
Treatment: Other
Comparator / control treatment
The control group will receive usual care in the 6 weeks prior to receiving the intervention treatment.The usual care includes multidisciplinary rehabilitation provided by the unit as appropriate. This consisted of physiotherapy, occupational therapy, speech therapy, recreational therapy and psychological therapy. Physiotherapy included an individualised motor training program which might involve lower limb exercises, practice of sit to stand, standing and walking. The usual care also involves positioning of participants’ feet in dorsiflexion while seated and lying.
Control group
Active

Outcomes
Primary outcome [1] 294834 0
Passive dosiflexion range at a standardised torque
Timepoint [1] 294834 0
The primary timepoint is post interventions (i.e., following the completion of botulinum toxin and serial casting). The duration of casting and number of cast applied may vary based on the participants’ responses to casting. It can range from 4 to 9 weeks. The primary timepoint will be within 3 days after completion of serial casting. Follow-up assessments will be conducted at week 2 and 8 post intervention, at time of discharge and if possible 1 year after discharge.
Secondary outcome [1] 314178 0
Spasticity of ankle plantarflexors (Tardieu Scale score)
Timepoint [1] 314178 0
The secondary timepoint is the same as the primary timepoint (i.e., following the completion of botulinum toxin and serial casting). The duration of casting and number of cast applied may vary based on the participants’ responses to casting. It can range from 4 to 9 weeks. The primary timepoint will be within 3 days after completion of serial casting. Follow-up assessments will be conducted at week 2 and 8 post intervention, at time of discharge and if possible 1 year after discharge.
Secondary outcome [2] 314179 0
Activity limitations: FIM score for walking item and 10-metre walk test
Timepoint [2] 314179 0
The secondary timepoint is the same as the primary timepoint (i.e., following the completion of botulinum toxin and serial casting). The duration of casting and number of cast applied may vary based on the participants’ responses to casting. It can range from 4 to 9 weeks. The primary timepoint will be within 3 days after completion of serial casting. Follow-up assessments will be conducted at week 2 and 8 post intervention, at time of discharge and if possible 1 year after discharge.
Secondary outcome [3] 315478 0
Therapist questionnaire (perceived effectiveness, adverse events and treatment worth) is a secondary outcome measure. It is designed specifically for this study.
Timepoint [3] 315478 0
The secondary timepoint is the same as the primary timepoint (i.e., following the completion of botulinum toxin and serial casting). The duration of casting and number of cast applied may vary based on the participants’ responses to casting. It can range from 4 to 9 weeks. The primary timepoint will be within 3 days after completion of serial casting. Follow-up assessments will be conducted at week 2 and 8 post intervention, at time of discharge and if possible 1 year after discharge.

Eligibility
Key inclusion criteria
-diagnosed with acquired brain injury and admitted for sub-acute rehabilitation
-presents with an ankle contracture of a severe degree
-able to receive botulinum toxin injections and serial casting
-unlikely to be discharged in 12 weeks, and
-provide consent to participate in the study (the participants or the person legally responsible for them (This person can be legal guardian/next of kin or carer as determined by law)
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-unstable medical conditions or recent ankle fractures
-within 3 months after receiving botulinum toxin
-severe ankle varus or knee/hip flexion contractures (which affects the reliability of measuring ankle dorsiflexion)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The physiotherapists of the Brain Injury Unit will screen all existing patients and all new admissions. Outcomes of screening will be recorded on the Screening Log. Passive dorsiflexion range of motion of patients will be measured with a goniometer and manual stretch. When an eligible participant is identified, the physiotherapists will notify the Investigators who will confirm participant’s eligibility.
Potential participants or the persons responsible for them will be given the Participant / Person Responsible Information Sheets. An investigator will explain the study protocol to them. No pressure to participate will be placed on the potential participant under any circumstances. The potential participants will be informed that participation in the study is entirely voluntary and they are free to withdraw from the study at any stage without any effect on their current or future treatment. Those who agree to participate will be given the Consent Form to sign and commence involvement in the study.
Health care interpreters will be used for potential participants who cannot speak English.
The random allocation sequence will be computer-generated by an administrative assistant who will not be involved in the study. Group allocation will be concealed using consecutively numbered, sealed, opaque envelopes which will be kept away from investigators/therapists. After baseline assessment, the investigator will contact the administrative assistant to open the envelope and reveal the group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence will be computer generated (i.e.,a simple randomisation using a randomisation table created by computer software - computerised sequence generation) by a person not involved in the recruitment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
In addition to between group comparisons at completion of casting and 2 weeks following that, there will be follow-up assessments for both the experimental group and control group 8 weeks post-intervention, at the time of discharge and if possible 1 year after discharge. The same assessment as listed in step 4 will be conducted at all these additional timepoints. A questionnaire will be used to collect feedback from participants or persons responsible for them if participants cannot provide feedback themselves.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size has been calculated apriori based on best estimates. A sample of 10 participants will be recruited to provide an 80% probability of detecting a between-group difference of 20 degrees for the primary outcome, assuming a standard deviation of 5 degrees (Moseley 1997) and a 10% drop-out rate.
General Linear Regression analyses were performed to assess passive dorsiflexion, walking speed, Functional Independent Measure score for the walking item and spasticity. The significance level was set at < 0.05. Analyses were conducted separately for the end of intervention and follow-up assessments. Missing data were not imputed. All analyses were performed according to ‘intention-to-treat’.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
4/06/2015
Actual
20/08/2015
Date of last participant enrolment
Anticipated
1/09/2018
Actual
28/11/2017
Date of last data collection
Anticipated
1/12/2019
Actual
Sample size
Target
10
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 4057 0
Royal Rehabilitation Hospital - Coorabel/Moorong - Ryde
Recruitment postcode(s) [1] 9538 0
2112 - Ryde

Funding & Sponsors
Funding source category [1] 291114 0
Charities/Societies/Foundations
Name [1] 291114 0
Royal Rehab Foundation
Country [1] 291114 0
Australia
Primary sponsor type
Hospital
Name
Royal Rehab
Address
227 Morrison Road, RYDE NSW 2112
Country
Australia
Secondary sponsor category [1] 289790 0
None
Name [1] 289790 0
Address [1] 289790 0
Country [1] 289790 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292695 0
Northern Sydney Local Health District
Ethics committee address [1] 292695 0
Kolling Building, Level 13, Royal North Shore Hospital, St Leonards NSW 2065
Ethics committee country [1] 292695 0
Australia
Date submitted for ethics approval [1] 292695 0
08/09/2014
Approval date [1] 292695 0
02/12/2014
Ethics approval number [1] 292695 0
RESP/14/213
Ethics committee name [2] 293228 0
HREC of Royal Rehab
Ethics committee address [2] 293228 0
235 Morrison Road, RYDE NSW 2112
Ethics committee country [2] 293228 0
Australia
Date submitted for ethics approval [2] 293228 0
17/12/2014
Approval date [2] 293228 0
01/07/2015
Ethics approval number [2] 293228 0
15SSA01

Summary
Brief summary
The primary objective of the project is to determine the effectiveness of a treatment program combining serial casting with Botulinum Toxin for the management of contractures in adults with acquired brain injury. An assessor blinded, randomised controlled study with a cross-over design will be conducted. Ankle joint is selected as a model to assess the effectiveness of the intervention. Participants will be adults with acquired brain injury admitted to the Brain Injury Rehabilitation Unit of Royal Rehab for sub-acute rehabilitation. Between-group comparisons will be made to determine the effectiveness of the intervention program. The participants in the control group will be placed on a wait list for the same treatment program. Pre-and post-intervention comparisons will also be made within the control group. Follow-up assessments for both the experimental group and control group will be conducted 8 weeks post interventions, at discharge and if possible 1 year after discharge to assess the long-term effects of the interventions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45798 0
Dr Joan Wai King Leung
Address 45798 0
Brain Injury Unit, Royal Rehab, 227 Morrison Road, RYDE NSW 2112
Country 45798 0
Australia
Phone 45798 0
+6, 12, 98099020
Fax 45798 0
+6, 12, 98077484
Email 45798 0
[email protected]
Contact person for public queries
Name 45799 0
Dr Joan Wai King Leung
Address 45799 0
Brain Injury Unit, Royal Rehab, 227 Morrison Road, RYDE NSW 2112
Country 45799 0
Australia
Phone 45799 0
+6, 12, 98099020
Fax 45799 0
+6, 12, 98077484
Email 45799 0
[email protected]
Contact person for scientific queries
Name 45800 0
Dr Joan Wai King Leung
Address 45800 0
Brain Injury Unit, Royal Rehab, 227 Morrison Road, RYDE NSW 2112
Country 45800 0
Australia
Phone 45800 0
+6, 12, 98099020
Fax 45800 0
+6, 12, 98077484
Email 45800 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23313Study protocol    365685-(Uploaded-12-08-2020-08-10-45)-Study-related document.doc
23314Informed consent form    365685-(Uploaded-12-08-2020-08-11-03)-Study-related document.doc

Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3962Plain language summaryNo This randomised controlled trial investigated a mu... [More Details]
4453Study results articleYes Clinical Rehabilitation 2019, Vol. 33(6) 1035–1044... [More Details]

Documents added automatically
No additional documents have been identified.