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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 information initially provided
14/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Intensive rehabilitation after botulinum toxin-A injections in stroke.
Scientific title
Effect of adding intensive upper limb rehabilitation to botulinum toxin-A on upper limb activity after stroke: the InTENSE trial.
Secondary ID [1] 286713 0
Nil
Universal Trial Number (UTN)
Trial acronym
InTENSE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 295072 0
Condition category
Condition code
Physical Medicine / Rehabilitation 295321 295321 0 0
Occupational therapy
Physical Medicine / Rehabilitation 295322 295322 0 0
Physiotherapy
Stroke 295529 295529 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 291868 0
Rehabilitation
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.
Control group
Active

Outcomes
Primary outcome [1] 295062 0
Upper limb activity will be measured using the Box and Block Test.
Timepoint [1] 295062 0
Baseline (pre-randomisation), 12 weeks and 12 months
Primary outcome [2] 295063 0
Individualised achievement of goals will be measured using Goal Attainment Scale
Timepoint [2] 295063 0
12 weeks and 12 months
Secondary outcome [1] 314685 0
Spasticity will be measured using the Tardieu scale
Timepoint [1] 314685 0
Baseline (pre-randomisation) and 12 weeks
Secondary outcome [2] 314686 0
Passive wrist extension will be measured using torque-controlled goniometry.
Timepoint [2] 314686 0
Baseline (pre-randomisation),12 weeks and 12 months
Secondary outcome [3] 314687 0
Health related quality of life will be measured using the EQ-5D
Timepoint [3] 314687 0
Baseline (pre-randomisation), 12 weeks and 12 months
Secondary outcome [4] 339828 0
Grip strength will be measured as a maximum voluntary contraction using dynamometry
Timepoint [4] 339828 0
Baseline (pre-randomisation), 12 weeks and 12 months
Secondary outcome [5] 339829 0
Pain will be measured using a 10-cm visual analogue scale
Timepoint [5] 339829 0
Baseline (pre-randomisation), 12 weeks and 12 months
Secondary outcome [6] 339830 0
Burden of care will be measured using the Carer Burden Scale
Timepoint [6] 339830 0
Baseline (pre-randomisation), 12 weeks and 12 months

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

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)
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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/07/2015
Actual
3/07/2015
Date of last participant enrolment
Anticipated
Actual
27/06/2018
Date of last data collection
Anticipated
Actual
26/06/2019
Sample size
Target
136
Accrual to date
Final
140
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 9190 0
The Alfred - Prahran
Recruitment hospital [2] 9191 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 9192 0
Royal Talbot Rehabilitation Centre - Kew
Recruitment hospital [4] 9193 0
Epworth Rehabilitation Camberwell - Camberwell
Recruitment hospital [5] 9194 0
Hampstead Rehabilitation Centre - Northfield
Recruitment hospital [6] 9195 0
Repatriation General Hospital - Daw Park
Recruitment hospital [7] 9196 0
St Joseph's Hospital - Auburn
Recruitment hospital [8] 9197 0
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 17843 0
3004 - Prahran
Recruitment postcode(s) [2] 17844 0
3084 - Heidelberg
Recruitment postcode(s) [3] 17845 0
3101 - Kew
Recruitment postcode(s) [4] 17846 0
3124 - Camberwell
Recruitment postcode(s) [5] 17847 0
5085 - Northfield
Recruitment postcode(s) [6] 17848 0
5041 - Daw Park
Recruitment postcode(s) [7] 17849 0
2144 - Auburn
Recruitment postcode(s) [8] 17850 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 291276 0
Government body
Name [1] 291276 0
National Health and Medical Research Council
Country [1] 291276 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Bundoora, VIC, 3086
Country
Australia
Secondary sponsor category [1] 289950 0
Hospital
Name [1] 289950 0
Alfred Health
Address [1] 289950 0
55 Commercial Road, Melbourne, Victoria 3004
Country [1] 289950 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292836 0
Alfred Hospital Human Research Ethics Committee
Ethics committee address [1] 292836 0
C/- The Alfred Hospital, 55 Commercial Road, Melbourne, Victoria 3004
Ethics committee country [1] 292836 0
Australia
Date submitted for ethics approval [1] 292836 0
Approval date [1] 292836 0
11/12/2014
Ethics approval number [1] 292836 0
442-14
Ethics committee name [2] 292986 0
La Trobe University
Ethics committee address [2] 292986 0
La Trobe University Bundoora, VIC, 3086
Ethics committee country [2] 292986 0
Australia
Date submitted for ethics approval [2] 292986 0
Approval date [2] 292986 0
05/02/2015
Ethics approval number [2] 292986 0
UHEC acceptance 442/14

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57282 0
A/Prof Natasha Lannin
Address 57282 0
Alfred Health
Occupational Therapy Department
55 Commercial Road, Prahran VIC 3181
Country 57282 0
Australia
Phone 57282 0
+61 417135153
Fax 57282 0
Email 57282 0
[email protected]
Contact person for public queries
Name 57283 0
Natasha Lannin
Address 57283 0
Alfred Health
Occupational Therapy Department
55 Commercial Road, Prahran VIC 3181
Country 57283 0
Australia
Phone 57283 0
+61 417135153
Fax 57283 0
Email 57283 0
[email protected]
Contact person for scientific queries
Name 57284 0
Natasha Lannin
Address 57284 0
Alfred Health
Occupational Therapy Department
55 Commercial Road, Prahran VIC 3181
Country 57284 0
Australia
Phone 57284 0
+61 417135153
Fax 57284 0
Email 57284 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13560Study protocolLannin, 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Natasha A. Lannin, Louise Ada, Coralie English, Ju... [More Details]
Plain language summaryNo The study, published in Stroke, found no differenc... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect of adding upper limb rehabilitation to botulinum toxin-A on upper limb activity after stroke: Protocol for the InTENSE trial.2018https://dx.doi.org/10.1177/1747493018765228
EmbaseViability of using a computer tablet to monitor an upper limb home exercise program in stroke.2021https://dx.doi.org/10.1080/09593985.2019.1625092
EmbaseLong-term effect of additional rehabilitation following botulinum toxin-A on upper limb activity in chronic stroke: the InTENSE randomised trial.2022https://dx.doi.org/10.1186/s12883-022-02672-8
N.B. These documents automatically identified may not have been verified by the study sponsor.