ANZCTR - Registration

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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.

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]

Nil

Universal Trial Number (UTN)

Trial acronym

InTENSE

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Stroke

Condition category

Condition code

Physical Medicine / Rehabilitation

Occupational therapy

Physical Medicine / Rehabilitation

Physiotherapy

Stroke

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]

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]

Upper limb activity will be measured using the Box and Block Test.

Timepoint [1]

Baseline (pre-randomisation), 12 weeks and 12 months

Primary outcome [2]

Individualised achievement of goals will be measured using Goal Attainment Scale

Timepoint [2]

12 weeks and 12 months

Secondary outcome [1]

Spasticity will be measured using the Tardieu scale

Timepoint [1]

Baseline (pre-randomisation) and 12 weeks

Secondary outcome [2]

Passive wrist extension will be measured using torque-controlled goniometry.

Timepoint [2]

Baseline (pre-randomisation),12 weeks and 12 months

Secondary outcome [3]

Health related quality of life will be measured using the EQ-5D

Timepoint [3]

Baseline (pre-randomisation), 12 weeks and 12 months

Secondary outcome [4]

Grip strength will be measured as a maximum voluntary contraction using dynamometry

Timepoint [4]

Baseline (pre-randomisation), 12 weeks and 12 months

Secondary outcome [5]

Pain will be measured using a 10-cm visual analogue scale

Timepoint [5]

Baseline (pre-randomisation), 12 weeks and 12 months

Secondary outcome [6]

Burden of care will be measured using the Carer Burden Scale

Timepoint [6]

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?

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]

The Alfred - Prahran

Recruitment hospital [2]

Austin Health - Austin Hospital - Heidelberg

Recruitment hospital [3]

Royal Talbot Rehabilitation Centre - Kew

Recruitment hospital [4]

Epworth Rehabilitation Camberwell - Camberwell

Recruitment hospital [5]

Hampstead Rehabilitation Centre - Northfield

Recruitment hospital [6]

Repatriation General Hospital - Daw Park

Recruitment hospital [7]

St Joseph's Hospital - Auburn

Recruitment hospital [8]

St Vincent's Private Hospital (Darlinghurst) - Darlinghurst

Recruitment postcode(s) [1]

3004 - Prahran

Recruitment postcode(s) [2]

3084 - Heidelberg

Recruitment postcode(s) [3]

3101 - Kew

Recruitment postcode(s) [4]

3124 - Camberwell

Recruitment postcode(s) [5]

5085 - Northfield

Recruitment postcode(s) [6]

5041 - Daw Park

Recruitment postcode(s) [7]

2144 - Auburn

Recruitment postcode(s) [8]

2010 - Darlinghurst

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

La Trobe University

Address

Bundoora, VIC, 3086

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Alfred Health

Address [1]

55 Commercial Road, Melbourne, Victoria 3004

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Hospital Human Research Ethics Committee

Ethics committee address [1]

C/- The Alfred Hospital, 55 Commercial Road, Melbourne, Victoria 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

11/12/2014

Ethics approval number [1]

442-14

Ethics committee name [2]

La Trobe University

Ethics committee address [2]

La Trobe University Bundoora, VIC, 3086

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

05/02/2015

Ethics approval number [2]

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

A/Prof Natasha Lannin

Address

Alfred Health
Occupational Therapy Department
55 Commercial Road, Prahran VIC 3181

Country

Australia

Phone

+61 417135153

Fax

n.lannin@latrobe.edu.au

Contact person for public queries

Name

Natasha Lannin

Address

Alfred Health
Occupational Therapy Department
55 Commercial Road, Prahran VIC 3181

Country

Australia

Phone

+61 417135153

Fax

N.Lannin@latrobe.edu.au

Contact person for scientific queries

Name

Natasha Lannin

Address

Alfred Health
Occupational Therapy Department
55 Commercial Road, Prahran VIC 3181

Country

Australia

Phone

+61 417135153

Fax

N.Lannin@latrobe.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

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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