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Trial registered on ANZCTR


Registration number
ACTRN12614001162606
Ethics application status
Approved
Date submitted
16/10/2014
Date registered
4/11/2014
Date last updated
7/12/2018
Date data sharing statement initially provided
7/12/2018
Date results information initially provided
7/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Can early active repetitive motor training prevent development of upper limb contracture after stroke? A randomised trial.
Scientific title
Does early active repetitive motor training for inpatient stroke survivors with upper limb hemiplegia prevent loss of passive range of motion in the upper limb more than standard upper limb rehabilitation?
Secondary ID [1] 285505 0
Nil Known
Universal Trial Number (UTN)
U1111-1162-9542
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Upper limb hemiplegia following stroke 293297 0
Upper limb contracture following stroke 293298 0
Condition category
Condition code
Stroke 293571 293571 0 0
Ischaemic
Stroke 293572 293572 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 293682 293682 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Early active repetitive motor training for a maximum of 1 hour per day, in addition to usual upper limb therapy programs, 5 days a week for 5 weeks. Early active repetitive motor training will be delivered using the SMART Arm device. The SMART Arm is a non-robotic device which enables intensive and repetitive reaching practice by patients with severe upper limb weakness. Training using the SMART Arm will involve repeatedly practicing a reaching task by pushing the arm along a track to reach a goal e.g. to reach to a goal line or grasp an object. to help the participant achieve the movement, electrical stimulation may be applied to one or more muscles which straighten the arm or open the hand. Training may be progressed by increasing the number of repetitions and speed, adding weight, elevating the work surface and including a number of grasping tasks.
There will be no minimum amount of training time or repetitions. Compliance to the intervention will be monitored daily using SMART Arm training record sheets by the treating therapists. Data collected will include time spent training, number of repetitions & amount of supervision for each session.
Physiotherapists, Occupational Therapists and Allied health assistants who are trained in use of the SMART Arm device, will administer the training.
The amount of supervision required for SMART Arm training will vary, and it is envisioned that many patients will be able to use the device with minimal supervision once set up.
Intervention code [1] 290443 0
Rehabilitation
Intervention code [2] 290487 0
Treatment: Devices
Comparator / control treatment
Usual upper limb therapy program only, 5 days a week for 5 weeks.
The duration of "Usual upper limb therapy" will not be prescribed in this trial. Daily data will be collected for each participant regarding the amount of "usual upper limb therapy" in terms of time, and usual therapy will be categorised as active or passive interventions.
Usual upper limb therapy will be provided by physiotherapists, occupational therapists and therapy assistants as would normally occur in both study sites, and may include one to one therapy, semi-supervised or group practice sessions.
Usual therapy will not be prescribed, but normally consists of task specific training of upper limb tasks. Usual upper limb training will be quantified in terms of time and categorised.
Control group
Active

Outcomes
Primary outcome [1] 293381 0
Passive range of motion of wrist extension. Torque controlled measures of passive wrist extension in degrees will be obtained using the procedure and measurement device described by Harvey et al (1994). Measurements using a standardized protocol will be used to decrease variability. The procedure has been used in previous research investigating contracture following stroke (Lannin et al 2003, Lannin et al 2007, Horsley et al 2007).
Timepoint [1] 293381 0
5 weeks
Primary outcome [2] 293382 0
Passive range of motion of shoulder flexion. Passive range of shoulder flexion will be measured using the “HALO” digital goniometer, using a standardised procedure.
Timepoint [2] 293382 0
5 weeks
Primary outcome [3] 293383 0
Passive range of motion of elbow extension.Torque controlled passive range of elbow extension will be measured with the “HALO” digital goniometer using a standardized procedure. Intra and inter-rater reliability of the “HALO” digital goniometer has been demonstrated by previous research conducted by the University of Western Australia.
Timepoint [3] 293383 0
5 weeks
Secondary outcome [1] 310894 0
Passive range of motion of shoulder external rotation. Passive range of shoulder external rotation will be measured with the “HALO” digital goniometer, using a standardised procedure.
Timepoint [1] 310894 0
5 weeks
Secondary outcome [2] 310895 0
Pain at rest. Pain at rest will be measured using a 10cm vertical visual analogue scale (McCaffery and Pasero 1999).
Timepoint [2] 310895 0
5 weeks
Secondary outcome [3] 310896 0
Arm function using the Motor Assessment Scale (MAS). A composite of the three upper limb items of the Motor Assessment scale (Carr et al 1985, Lannin 2004) will be used to score upper limb function between 0 points (no function) and 18 points (best possible score/good functional ability).
Timepoint [3] 310896 0
5 weeks
Secondary outcome [4] 310897 0
Passive range of motion of wrist. Torque controlled measures of passive wrist extension in degrees will be obtained using the procedure and measurement device described by Harvey et al (1994). Measurements using a standardized protocol will be used to decrease variability. The procedure has been used in previous research investigating contracture following stroke (Lannin et al 2003, Lannin et al 2007, Horsley et al 2007).
Timepoint [4] 310897 0
Follow up at 7 weeks
Secondary outcome [5] 310898 0
Pasive range of motion of shoulder flexion. Passive range of shoulder flexion will be measured using the “HALO” digital goniometer, using a standardised procedure.
Timepoint [5] 310898 0
Follow-up at 7 weeks
Secondary outcome [6] 310899 0
Passive range of motion of elbow extension. Torque controlled passive range of elbow extension will be measured with the “HALO” digital goniometer using a standardized procedure. Intra and inter-rater reliability of the “HALO” digital goniometer has been demonstrated by previous research conducted by the University of Western Australia.
Timepoint [6] 310899 0
Follow-up at 7 weeks
Secondary outcome [7] 310900 0
Passive range of motion of shoulder external rotation will be measured with the “HALO” digital goniometer, using a standardised procedure.
Timepoint [7] 310900 0
Follow-up at 7 weeks
Secondary outcome [8] 310901 0
Pain at rest. Pain at rest will be measured using a 10cm vertical visual analogue scale (McCaffery and Pasero 1999).
Timepoint [8] 310901 0
Follow-up at 7 weeks
Secondary outcome [9] 310902 0
Arm function (MAS).A composite of the three upper limb items of the Motor Assessment scale (Carr et al 1985, Lannin 2004) will be used to score upper limb function between 0 points (no function) and 18 points (best possible score/good functional ability).
Timepoint [9] 310902 0
Follow-up at 7 weeks
Secondary outcome [10] 310903 0
Participant's perceptions of upper limb rehabilitation, using semi-structured interviews with 10 participants.
Timepoint [10] 310903 0
After the 5 week intervention period
Secondary outcome [11] 311069 0
Pain during movement. Pain on movement (during upper limb range of motion measures) will be measured using a 10cm vertical visual analogue scale (McCaffery and Pasero 1999).
Timepoint [11] 311069 0
5 weeks
Secondary outcome [12] 311070 0
Impact of pain on sleep.The effect of pain on ability to sleep at night will be assessed using the relevant question contained in the “DASH” (Disabilities of the Arm, Shoulder and Hand) questionnaire.
Timepoint [12] 311070 0
5 weeks
Secondary outcome [13] 311071 0
Pain during arm movement. Pain on movement (during upper limb range of motion measures) will be measured using a 10cm vertical visual analogue scale (McCaffery and Pasero 1999).
Timepoint [13] 311071 0
7 weeks
Secondary outcome [14] 311072 0
Effect of pain on sleep. The effect of pain on ability to sleep at night will be assessed using the relevant question contained in the “DASH” (Disabilities of the Arm, Shoulder and Hand) questionnaire.
Timepoint [14] 311072 0
7 weeks

Eligibility
Key inclusion criteria
At least 10 days and no more than 6 months post stroke or stroke-like brain injury, unable to extend the affected wrist past neutral or flex the affected shoulder to greater than 90 degrees with the elbow extended.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Language, comprehension or cognitive problems which prevent informed consent and/or participation in the study. Co-existing upper limb problems which directly affect movement. Cannot participate in rehabilitation.

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)
All patients admitted with stroke or stroke like brain injury will be screened. Eligible patients will be informed about the study & invited to participate. Written informed consent will be obtained from all participants.
Baseline measures will be collected prior to participants being randomized into either the experimental or the control group. Once a potential participant has provided informed consent, one of the investigators will telephone an off-site administrator who will advise the investigator of that participant’s allocation. This process ensures concealment of the allocation schedule from potential participants and staff recruiting participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation schedule will be generated by a person who is not otherwise involved in the day-to-day conduct of the trial. The “ralloc” user-written routine in Stata will be used for this purpose. The allocation schedule will be blocked. Allocation will be in random permuted blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Statistical analysis
The expected (mean) effect of the experimental intervention will be estimated from the difference between the mean outcomes of the experimental and control groups. The primary analyses will be an intention to treat analysis. The focus will be on estimation of effects rather than hypothesis testing.

The primary analysis will estimate the mean difference in passive wrist and finger extension, elbow extension and shoulder external rotation range of motion between the experimental and control groups at 5 weeks. Confidence intervals will be constructed using the t-distribution.

Secondary analyses will estimate the mean difference in each of the secondary outcomes between the experimental and Control groups. Confidence intervals will be constructed using the t-distribution.

Sample size
The sample size of 50 is designed to give a 90% power to detect a 10 degree effect on each of the primary outcome variables. This assumes a SD of 10 degrees and a two-tailed alpha of 0.05.

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)
QLD
Recruitment hospital [1] 12673 0
Sunshine Coast University Hospital - Birtinya
Recruitment postcode(s) [1] 25095 0
4575 - Birtinya

Funding & Sponsors
Funding source category [1] 290104 0
Charities/Societies/Foundations
Name [1] 290104 0
Wishlist Sunshine Coast Health Foundation
Address [1] 290104 0
PO Box 2610, Nambour West, QLD.4560
Country [1] 290104 0
Australia
Primary sponsor type
Individual
Name
Sally Horsley
Address
Sunshine Coast University Hospital,
Doherty Street,
Birtinya. QLD. 4575.
Country
Australia
Secondary sponsor category [1] 288812 0
None
Name [1] 288812 0
Address [1] 288812 0
Country [1] 288812 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291812 0
Townsville Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 291812 0
HREC, Townsville Hospital & Health Service, IMB 52, PO Box 670, Townsville. QLD. 4810.
Ethics committee country [1] 291812 0
Australia
Date submitted for ethics approval [1] 291812 0
Approval date [1] 291812 0
09/10/2014
Ethics approval number [1] 291812 0
HREC/14/QTHS/124

Summary
Brief summary
The primary aim of this study is to investigate whether five weeks of up to one hour daily of early, active, repetitive motor training in addition to usual upper limb therapy can prevent upper limb contractures after stroke or other types of ABI. Secondary aims are to determine the effect of this intervention on upper limb function and upper limb pain, and to investigate patients’ perspectives of the intervention.
The study will be a parallel group, randomized controlled trial, with blinding of assessors and concealed randomization. Pre-intervention outcome measures will be taken prior to participants being randomized into either the experimental or the control group. Participants in the experimental group will receive a maximum of 1 hour a day of early active repetitive motor training using the SMART Arm device plus usual upper limb therapy, five days a week, for five weeks, in addition to the usual upper limb therapy. Participants in the control group will receive usual upper limb therapy only. The intervention will cease at the end of 5 weeks and outcome measures for both groups will be collected at that time. Follow-up outcome measures will be collected at 7 weeks. Qualitative interviews with ten participants from the experimental group will be undertaken at the end of the intervention period.
Trial website
http://www.ANZCTR.org.au/ACTRN12614001162606.aspx
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52126 0
Ms Sally Horsley
Address 52126 0
Physiotherapist, Rehabilitation Unit, Sunshine Coast University Hospital, Birtinya. QLD. 4575
Country 52126 0
Australia
Phone 52126 0
+61 0427853573
Fax 52126 0
Email 52126 0
sally.horsley@health.qld.gov.au
Contact person for public queries
Name 52127 0
Ms Sally Horsley
Address 52127 0
Physiotherapist, Rehabilitation Unit, Sunshine Coast University Hospital, Birtinya. QLD. 4575
Country 52127 0
Australia
Phone 52127 0
+61 0427853573
Fax 52127 0
Email 52127 0
sally.horsley@health.qld.gov.au
Contact person for scientific queries
Name 52128 0
Ms Sally Horsley
Address 52128 0
Physiotherapist, Rehabilitation Unit, Sunshine Coast University Hospital, Birtinya. QLD. 4575
Country 52128 0
Australia
Phone 52128 0
+61 0427853573
Fax 52128 0
Email 52128 0
sally.horsley@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Raw data will be shared as supplementary data when the trial is accepted for publication.
When will data be available (start and end dates)?
The data will be put online as supplementary data when the paper is published and so, because we don't know when it will be published, I am not able to specify a date.
Available to whom?
Open access
Available for what types of analyses?
All
How or where can data be obtained?
Online through Journal in which the trial is published
What supporting documents are/will be available?
Study protocol
Analytic code
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary