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Trial registered on ANZCTR


Registration number
ACTRN12612000091808
Ethics application status
Approved
Date submitted
28/12/2011
Date registered
18/01/2012
Date last updated
25/04/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of best practise therapy after Botulinum Toxin A injections for adults diagnosed with neurological impairment and onset of spasticity.
Scientific title
The effectiveness of best practise therapy after Botulinum Toxin A injections for adults diagnosed with neurological impairment and onset of upper or lower limb spasticity as measured by attainment of goals.
Secondary ID [1] 263064 0
Nil
Universal Trial Number (UTN)
Trial acronym
InTENSE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 270798 0
Acquired Brain Injury 270800 0
Spasticity 285506 0
Condition category
Condition code
Stroke 270991 270991 0 0
Ischaemic
Stroke 270992 270992 0 0
Haemorrhagic
Neurological 270993 270993 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group A: Best practice therapy.
Best practise therapy provided by an occupational or physical therapist including evidence-based protocols for casting, electrical stimulation, task-specific movement training and home practise. 14 sessions (1 hour per session) of best practice therapy is provided over 8 weeks (2 weeks of casting (1 session per week), followed by 2 weeks of 3 x weekly therapy, then 2 weeks of 2x weekly therapy, and finishing with 2 weeks of 1 x weekly therapy).

Group B: Best practise therapy plus botulinum toxin injections.
A single dose of Botulinum toxin- A will be injected at baseline only and follow the 2009 British Society of Rehabilitation Medicine national guidelines (Spasticity in adults: management using botulinum toxin).
Botox (Registered Trademark) botulinum toxin type A toxin is used in this trial.
Botulinum toxin-A is injected intramuscularly into specifically selected muscles, determined by the treating rehabilitation physician. Larger superficial muscles may be identified with knowledge of surface anatomy; smaller muscles may require use of nerve stimulation or EMG to ensure correct placement of the injection,
Dose will be individually determined based on the participant's identified needs and clinical goals. A maximum dose of 360U Botox (Registered Trademark) will be provided in a single adult injection session.
Intervention code [1] 269415 0
Rehabilitation
Intervention code [2] 283973 0
Treatment: Drugs
Comparator / control treatment
Group C: Botulinum toxin injection only (i.e. without best practise therapy).
Control group
Active

Outcomes
Primary outcome [1] 279656 0
Goal attainment as measured using the Goal Attainment Scale t-score change score.
Timepoint [1] 279656 0
Baseline, 8 weeks and 90 days.
Secondary outcome [1] 294136 0
Hand dexterity as measured using the Box and Block Test change score.
Timepoint [1] 294136 0
Baseline, 8 weeks and 90 days.
Secondary outcome [2] 294137 0
Functional mobility as measured by the 6m walk test change score.
Timepoint [2] 294137 0
Baseline, 8 weeks and 90 days.
Secondary outcome [3] 294138 0
Spasticity and hypertonicity rating as measured by the Tardieu Scale (spasticity angle change score and spasticity quality of movement rating)
Timepoint [3] 294138 0
Baseline, 8 weeks and 90 days.

Eligibility
Key inclusion criteria
Diagnosis of neurological injury (including stroke and brain injury) and onset of spasticity in at least one limb

Minimum of one month post-neurological injury

Score of 21 or greater on the Mini-Mental State Examination (Folstein, Folstein and McHugh, 1975) as an indicator of sufficient cognitive ability to participate in the therapy program
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a. Significant speech or cognitive impairment which impedes ability to perform assessments.
b. Other significant upper limb impairment eg. Fracture or frozen shoulder within 6 months, severe arthritis, amputation.
c. Pregnancy or lactating/ or at risk of pregnancy and not willing to take adequate precautions against pregnancy for the duration of their involvement in the trial.
d. Presence of contraindications to intramuscular injections.
e. Presence of any and all contraindications to botulinum toxin-A which include bleeding disorders, myasthenia gravis and concurrent use of aminoglycosides.
f. Use of botulinum toxin to the limb in previous five months
g. Known allergy or hypersensitivity to any of the test compounds.
h. Previous enrolment in the study (participants may only enrol in the study for one dose of therapy via the trial).

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)
Allocation Concealment
A set of random numbers will be used to create an allocation sequence which will be contained in individual opaque envelopes for use by the chief investigator. As a person is recruited, the next envelope in the sequence is opened and the participant assigned to the stated group.
Implementation
All randomisation, sequence generation, and preparation of group allocation materials will be performed by a third party who has no direct contact with the clinical aspects of the trial. Telephone allocation will be administered by a research assistant; and this will occur after completion of all baseline outcome assessments.
Blinding Arrangements
Due to the overt nature of the interventions, participants (and their carers) and the injecting physician will not be blinded to group assignment. Assessors of outcomes will be blinded to group assignment, as will treating therapists who are providing the intensive therapy program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be block randomised into three groups (1:1:1) using a computer generated set of random numbers with groups equal at one timepoint (unknown) prior to end of treatment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)

Funding & Sponsors
Funding source category [1] 269885 0
Government body
Name [1] 269885 0
South Australian Department of Health
Address [1] 269885 0
PO Box 287 Rundle Mall Adelaide SA 5000
Country [1] 269885 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Natasha Lannin
Address
Alfred Health Clinical School
Level 4
The Alfred Centre
99 Commercial Road
Prahran VIC 3181
Country
Australia
Secondary sponsor category [1] 268901 0
Individual
Name [1] 268901 0
Professor Maria Crotty
Address [1] 268901 0
Professor of Rehabilitation and Aged Care Flinders University Repatriation General Hospital, Daws Road, Daw Park 5041 SA
Country [1] 268901 0
Australia
Other collaborator category [1] 260462 0
Individual
Name [1] 260462 0
Professor Julie Ratcliffe
Address [1] 260462 0
Flinders Clinical Effectiveness
Flinders University
GPO Box 2100, Adelaide 5001, South Australia
Country [1] 260462 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286401 0
Southern Adelaide Health Service / Flinders University Human Research Ethics Committee
Ethics committee address [1] 286401 0
Southern Adelaide Clinical Research Ethics Department
Room 2A/221 Level 2
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Ethics committee country [1] 286401 0
Australia
Date submitted for ethics approval [1] 286401 0
Approval date [1] 286401 0
03/09/2010
Ethics approval number [1] 286401 0
1/10/0178

Summary
Brief summary
This project will evaluate a client-centred motor-training intervention to improve functional outcome after botulinum toxin injection (BoNT-A) for people with a neurological injury (stroke or brain injury). Spasticity is common following stroke and those with greater spasticity typically experience less recovery. Current treatment for spasticity is to provide BoNT-A, an antispasticity drug. Some evidence exists to support the use of BoNT-A, but all studies recommend that BoNT-A be provided in conjunction with physical therapy. However, little direct evidence exists for optimum type, dosage and timing of therapy. Participants will be recruited on a consecutive admission basis from hospital outpatient spasticity clinic and receive an 8-week intervention which will include intensive one-on-one physiotherapy, behavioural strategies to increase patient motivation, and a task-specific home exercise program. A distinguishing feature of the program is that it is tailored to the specific needs of each participant, patients are extended to receive intensive physiotherapy practice, and the content is driven by the Clinical Guidelines for Stroke Management (National Stroke Foundation, 2010). Outcomes will be assessed at baseline, post-intervention, and at 3 months following the conclusion of intervention and will include assessment of functional movement, quality of life, and cost.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33178 0
Address 33178 0
Country 33178 0
Phone 33178 0
Fax 33178 0
Email 33178 0
Contact person for public queries
Name 16425 0
Natasha Lannin
Address 16425 0
Alfred Health Clinical School
Level 4
The Alfred Centre
99 Commercial Road
Prahran Victoria 3181
Country 16425 0
Australia
Phone 16425 0
+61 3 94796755
Fax 16425 0
+61 3 95332104
Email 16425 0
n.lannin@latrobe.edu.au
Contact person for scientific queries
Name 7353 0
Natasha Lannin
Address 7353 0
Alfred Health Clinical School
Level 4, The Alfred Centre
99 Commercial Road
Prahran Victoria 3181
Country 7353 0
Australia
Phone 7353 0
+61 3 94796755
Fax 7353 0
Email 7353 0
N.Lannin@latrobe.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary