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Trial registered on ANZCTR
Registration number
ACTRN12615000616572
Ethics application status
Approved
Date submitted
15/05/2015
Date registered
12/06/2015
Date last updated
14/10/2021
Date data sharing statement initially provided
14/10/2021
Date results provided
14/10/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Intensive rehabilitation after botulinum toxin-A injections in stroke.
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Scientific title
Effect of adding intensive upper limb rehabilitation to botulinum toxin-A on upper limb activity after stroke: the InTENSE trial.
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Secondary ID [1]
286713
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Nil
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Universal Trial Number (UTN)
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Trial acronym
InTENSE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Stroke
295072
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Condition category
Condition code
Physical Medicine / Rehabilitation
295321
295321
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0
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Occupational therapy
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Physical Medicine / Rehabilitation
295322
295322
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0
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Physiotherapy
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Stroke
295529
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0
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Haemorrhagic
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
An evidence-based therapy program is provided for 12 weeks immediately following botulinum toxin-A injection. The program commences with:
(1) Up to 3 serial casts applied to place the wrist in maximum extension for 2 weeks. Cast is applied the first working day following botulinum toxin-A injection; followed by
(2) 10 weeks of movement training, aimed at decreasing weakness (electrical stimulation and progressive resistance exercises) and improving movement (task-specific practice). Participants are encouraged to practice for 1 hour per day, 7 days a week during the 10 weeks (ie, approximately 70 hours in total inclusive of clinic based sessions). Participants are supported by a mix of clinic-based sessions, home visits, and phone calls. Clinic-based sessions will be conducted by a trained physical or occupational therapist (duration 1 hour, frequency decreasing (3 x per week initially, but decreasing to 1 x week by week 7)). Participants will receive a booklet outlining their movement training and a training log to record the number of minutes of practice daily.
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Intervention code [1]
291868
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Rehabilitation
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Comparator / control treatment
Written instructions plus follow-up telephone call post-clinic, as per usual care in Australia. Participants will receive a booklet containing 7 stretches, and 8 arm and hand exercises and a training log to record the number of minutes of practice daily.
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Control group
Active
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Outcomes
Primary outcome [1]
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Upper limb activity will be measured using the Box and Block Test.
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Assessment method [1]
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Timepoint [1]
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Baseline (pre-randomisation), 12 weeks and 12 months
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Primary outcome [2]
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Individualised achievement of goals will be measured using Goal Attainment Scale
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Assessment method [2]
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Timepoint [2]
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12 weeks and 12 months
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Secondary outcome [1]
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Spasticity will be measured using the Tardieu scale
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Assessment method [1]
314685
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Timepoint [1]
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Baseline (pre-randomisation) and 12 weeks
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Secondary outcome [2]
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Passive wrist extension will be measured using torque-controlled goniometry.
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Assessment method [2]
314686
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Timepoint [2]
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Baseline (pre-randomisation),12 weeks and 12 months
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Secondary outcome [3]
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Health related quality of life will be measured using the EQ-5D
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Assessment method [3]
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Timepoint [3]
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Baseline (pre-randomisation), 12 weeks and 12 months
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Secondary outcome [4]
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Grip strength will be measured as a maximum voluntary contraction using dynamometry
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Assessment method [4]
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Timepoint [4]
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Baseline (pre-randomisation), 12 weeks and 12 months
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Secondary outcome [5]
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Pain will be measured using a 10-cm visual analogue scale
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Assessment method [5]
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Timepoint [5]
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Baseline (pre-randomisation), 12 weeks and 12 months
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Secondary outcome [6]
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Burden of care will be measured using the Carer Burden Scale
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Assessment method [6]
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Timepoint [6]
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Baseline (pre-randomisation), 12 weeks and 12 months
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Eligibility
Key inclusion criteria
- Scheduled to receive a botulinum toxin-A injection to a muscle(s) that crosses the wrist
- Agreed to receive BoNT-A injections as part of their usual care
- Date of stroke three or more months prior.
- Not currently receiving upper limb rehabilitation
- Absence of significant cognitive impairment (as assessed by a score of less than five adjusted errors on the Short Portable Mental Status Questionnaire).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Unable to attend clinic at least 1/wk.
- Other significant upper limb impairment eg. Fracture or frozen shoulder within 6 months, severe arthritis, amputation.
- Presence of any and all contraindications to botulinum toxin-A injections.
- Botulinum toxin-A injections and/or serial casts in the past 6 months.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
For each clinic, allocation will occur in random permuted blocks so that after every block (of 4-8 participants), the experimental and control group will contain equal numbers. Randomization will occur after injection of botulinum toxin-A. The schedule will be stored off-site and group allocation will be revealed online.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be computer-generated, independent and concealed. The allocation sequence has been generated and will be managed by the Griffith Randomistation Service at Griffith University.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
3/07/2015
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Actual
3/07/2015
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Date of last participant enrolment
Anticipated
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Actual
27/06/2018
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Date of last data collection
Anticipated
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Actual
26/06/2019
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Sample size
Target
136
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Accrual to date
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Final
140
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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The Alfred - Prahran
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Recruitment hospital [2]
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Austin Health - Austin Hospital - Heidelberg
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Recruitment hospital [3]
9192
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Royal Talbot Rehabilitation Centre - Kew
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Recruitment hospital [4]
9193
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Epworth Rehabilitation Camberwell - Camberwell
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Recruitment hospital [5]
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Hampstead Rehabilitation Centre - Northfield
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Recruitment hospital [6]
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Repatriation General Hospital - Daw Park
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Recruitment hospital [7]
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St Joseph's Hospital - Auburn
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Recruitment hospital [8]
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St Vincent's Private Hospital (Darlinghurst) - Darlinghurst
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Recruitment postcode(s) [1]
17843
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3004 - Prahran
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Recruitment postcode(s) [2]
17844
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3084 - Heidelberg
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Recruitment postcode(s) [3]
17845
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3101 - Kew
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Recruitment postcode(s) [4]
17846
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3124 - Camberwell
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Recruitment postcode(s) [5]
17847
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5085 - Northfield
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Recruitment postcode(s) [6]
17848
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5041 - Daw Park
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Recruitment postcode(s) [7]
17849
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2144 - Auburn
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Recruitment postcode(s) [8]
17850
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2010 - Darlinghurst
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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National Health and Medical Research Council
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Address [1]
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GPO Box 1421
Canberra ACT 2601
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Country [1]
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Australia
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Primary sponsor type
University
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Name
La Trobe University
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Address
Bundoora, VIC, 3086
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Country
Australia
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Secondary sponsor category [1]
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Hospital
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Name [1]
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Alfred Health
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Address [1]
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55 Commercial Road, Melbourne, Victoria 3004
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Country [1]
289950
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
292836
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Alfred Hospital Human Research Ethics Committee
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Ethics committee address [1]
292836
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C/- The Alfred Hospital, 55 Commercial Road, Melbourne, Victoria 3004
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Ethics committee country [1]
292836
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Australia
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Date submitted for ethics approval [1]
292836
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Approval date [1]
292836
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11/12/2014
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Ethics approval number [1]
292836
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442-14
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Ethics committee name [2]
292986
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La Trobe University
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Ethics committee address [2]
292986
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La Trobe University Bundoora, VIC, 3086
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Ethics committee country [2]
292986
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Australia
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Date submitted for ethics approval [2]
292986
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Approval date [2]
292986
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05/02/2015
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Ethics approval number [2]
292986
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UHEC acceptance 442/14
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Summary
Brief summary
Impaired arm and hand function is a common and often devastating problem for stroke survivors. Regaining lost movement in the arm/hand is more difficult to achieve than walking, with only 5% of people with hemiplegia regaining functional use of their hand. This devastating outcome could potentially be addressed, however we do not yet know how to best increase movement in the arm and hand after stroke for patients with spasticity. There is a lack of randomized controlled trials of botulinum toxin A (BoNT-A) with a group who does not receive therapy in some dose, and so whether gains were achieved through BoNT-A or a combination of the BoNT-A and therapy cannot be determined from the studies to date.The research project is testing whether intense therapy given after botulinum toxin injections into the arm is more helpful than just the injections alone.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Natasha Lannin
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Address
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Alfred Health
Occupational Therapy Department
55 Commercial Road, Prahran VIC 3181
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Country
57282
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Australia
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Phone
57282
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+61 417135153
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Fax
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Email
57282
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[email protected]
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Contact person for public queries
Name
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Natasha Lannin
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Address
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Alfred Health
Occupational Therapy Department
55 Commercial Road, Prahran VIC 3181
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Country
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Australia
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Phone
57283
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+61 417135153
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Fax
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Email
57283
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[email protected]
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Contact person for scientific queries
Name
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Natasha Lannin
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Address
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Alfred Health
Occupational Therapy Department
55 Commercial Road, Prahran VIC 3181
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Country
57284
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Australia
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Phone
57284
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+61 417135153
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Fax
57284
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Email
57284
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
13560
Study protocol
Lannin, N. A., Ada, L., English, C., Ratcliffe, J., & Crotty, M. (2018). Effect of adding upper limb rehabilitation to botulinum toxin-A on upper limb activity after stroke: Protocol for the InTENSE trial. International Journal of Stroke, 13(6), 648–653. https://doi.org/10.1177/1747493018765228 Milte R, Ratcliffe J, Ada L, English C, Crotty M, Lannin NA. Protocol for the economic evaluation of the InTENSE program for rehabilitation of chronic upper limb spasticity. BMC Health Serv Res. 2020;20(1):478. Published 2020 May 27. doi:10.1186/s12913-020-05333-z
https://doi.org/10.1177/1747493018765228
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Effect of adding upper limb rehabilitation to botulinum toxin-A on upper limb activity after stroke: Protocol for the InTENSE trial.
2018
https://dx.doi.org/10.1177/1747493018765228
Embase
Viability of using a computer tablet to monitor an upper limb home exercise program in stroke.
2021
https://dx.doi.org/10.1080/09593985.2019.1625092
Embase
Long-term effect of additional rehabilitation following botulinum toxin-A on upper limb activity in chronic stroke: the InTENSE randomised trial.
2022
https://dx.doi.org/10.1186/s12883-022-02672-8
N.B. These documents automatically identified may not have been verified by the study sponsor.
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