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Trial registered on ANZCTR


Registration number
ACTRN12615000665538
Ethics application status
Approved
Date submitted
3/05/2015
Date registered
26/06/2015
Date last updated
11/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The EXTRA Practice Study: the feasibility of an extra practice upper limb protocol for adults after stroke
Scientific title
The EXTRA Practice Study: the feasibility of an extra practice upper limb protocol for adults after stroke
Secondary ID [1] 286606 0
Nil known
Universal Trial Number (UTN)
U1111-1169-7070
Trial acronym
EXTRA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 294828 0
Hemiplegia 294915 0
Condition category
Condition code
Neurological 295103 295103 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 295104 295104 0 0
Occupational therapy
Stroke 295657 295657 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be taught and supported to completed the EXTRA practice protocol for 60 minutes per day, six days per week for four weeks. Each 60 minute practice session will involve 30 minutes of Graded Repetitive Supplementary Program (GRASP) training and 30 minutes of the AbleX program. The EXTRA therapy program will be semi supervised by a qualified occupational therapist in a treatment room or in the patient's hospital room. The intervention period will extend for four weeks or until discharged from the rehabilitation unit (whichever is first; this study will not influence discharge dates which will be set by the treating rehabilitation team).

GRASP is an arm and hand exercise program developed for stroke patients with upper extremity impairments and allows patients to undertake a self-directed arm and hand exercise program. GRASP exercises may include functional tasks, fine motor skills and strengthening exercises. Participants will be asked to start the next day where they left off. Every participant will be started at Level 1 and will go up to the next level when they can complete the program in one quarter of the time required (25 minutes).
The AbleX is a computer based upper limb exercise system shown to be effective in providing repetitive, intense and engaging exercise that improves upper limb function. The AbleX runs thorough a Windows operating system on a laptop. Feedback on performance (accuracy), activity time (adherence) and exercise intensity is automatically captured with the exercise game.

Participants will be asked to record the duration of each practice session. Should participants not complete the required amount of daily practice their reasons for not training will be recorded. Participants can choose for greater or less than the required daily minimum.
Intervention code [1] 291687 0
Rehabilitation
Intervention code [2] 292151 0
Treatment: Other
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294865 0
Upper limb activity measured by the Box and Block Test
Timepoint [1] 294865 0
Baseline, week 1, week 2, week 3, week 4 after intervention commencement.
Primary outcome [2] 294866 0
Upper limb activity measured by the 9-Hole Peg Test
Timepoint [2] 294866 0
Baseline, week 1, week 2, week 3, week 4 after intervention commencement.
Primary outcome [3] 297715 0
Grip strength measured by hand grip dynamometer (kg)
Timepoint [3] 297715 0
Baseline, week 1, week 2, week 3, week 4 after intervention commencement.
Secondary outcome [1] 314256 0
Recruitment and consent rates including number of patients admitted with a diagnosis of stroke (screened), number with hemiparesis (eligible), number of people who decline participation (refused) as well as the number of people who commenced the study but opted to stop (study dropouts).
Timepoint [1] 314256 0
Six days per week, from first participant screened to finish of last participant.
Secondary outcome [2] 314257 0
Participation will be recorded by recording the amount of practice completed/not completed during each individual participant's practice. A Participant Practice Log has been prepared to measure the type of practice, number of sessions, duration of each session, duration of active practice, number of repetitions completed, number of health professionals present at each therapy session, success of each session and any reason for why a practice session was missed pr shorter than the time required.
Timepoint [2] 314257 0
Six days per week for 4 weeks from study commencement (repeated for each participant recruited).
Secondary outcome [3] 314258 0
Satisfaction will be measured using the simple question "Would you recommend this program to a friend who had suffered a stroke and couldn't move their arm normally?". We will additionally ask for participant feedback using a qualitative survey that has been designed specifically for this study..
Timepoint [3] 314258 0
4 weeks after intervention commencement (or the last session, if earlier)
Secondary outcome [4] 314259 0
Adverse events will be tracked and recorded as per the NHMRC Position Statement. Any adverse event will be mandatorily reported to the Chief Investigator and Ethics Committee. Any adverse events will be recorded and classified according to whether they could be attributed to the therapy provided. There are no known/possible adverse events relating to this study.
Timepoint [4] 314259 0
Daily, from start to end of intervention period.

Eligibility
Key inclusion criteria
- Medical diagnosis of stroke
- Presence of hemiparesis/hemiplegia
- Have a upper limb activity limitation (defined as <54 blocks on the Box and Block Test which is 20% reduction in the normative scores for adults aged 20-80 years)
- Have at least grade 1 wrist extension and grade 3 shoulder elevation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Have severe cognitive and/or language defects, which preclude them from following instructions in training sessions (score greater than or equal to 24 on the Mini Mental Status Examination)
- Have any medical condition that precludes them participating in a rehabilitation program aimed at upper limb activity

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will be identified by the investigators through the review of electronic inpatient ward lists and/or their medical record for confirmation of a diagnosis of stroke (screened) and the presence of hemiparesis/hemiplegia (eligible). Potential participants will be approached on the ward by a researcher who has no relationship with the potential participants to determine eligibility. If eligible, the researcher will then explain the study to potential participants and invite them to participate. Written information about the study will be provided to participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Repeated measures analyses of variance will be used to compare the changes in outcome measure variables from baseline to Week four. Mean within-group differences (MD) (95%CI) will be calculated. Probabilities of less than 0.05 will be considered significant. Descriptive data will be reported as aggregated data; mea (range) and mean (sd) will both be reported to permit future sample size calculations.

Feasibility will be analysed descriptively. Recruitment rates and proportions will be calculated. Counts for adverse events and an adverse event rate will be calculated. Sensitivity of outcome measures will also be evaluated and recommendations made about the outcome measures for future, larger, trials.

Because sample sizes are small (typically less than 30 participants) Phase 1 trials are only able to detect the feasibility of the intervention. The number of participants needed to achieve this study objectives was determined by the study design.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2015
Actual
27/07/2015
Date of last participant enrolment
Anticipated
12/09/2016
Actual
4/06/2016
Date of last data collection
Anticipated
11/09/2016
Actual
24/06/2016
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3721 0
Caulfield Hospital - Caulfield
Recruitment postcode(s) [1] 9543 0
3162 - Caulfield

Funding & Sponsors
Funding source category [1] 291136 0
Self funded/Unfunded
Name [1] 291136 0
Country [1] 291136 0
Primary sponsor type
Hospital
Name
Alfred Health
Address
Caulfield Hospital, 260 Kooyong Road, Caulfield, Victoria 3162, Australia.
Country
Australia
Secondary sponsor category [1] 289856 0
University
Name [1] 289856 0
La Trobe University
Address [1] 289856 0
Department of Occupational Therapy, Faculty of Health Sciences, La Trobe University, Plenty Road, Bundoora, Victoria 3086, Australia
Country [1] 289856 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292748 0
Alfred Health Ethics Committee
Ethics committee address [1] 292748 0
Ethics committee country [1] 292748 0
Australia
Date submitted for ethics approval [1] 292748 0
Approval date [1] 292748 0
31/03/2015
Ethics approval number [1] 292748 0
94/15

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56698 0
A/Prof Natasha Lannin
Address 56698 0
Occupational Therapy Department, Alfred Health, The Alfred, 55 Commercial Road, Prahran, Victoria 3181
Country 56698 0
Australia
Phone 56698 0
+61 03 94796745
Fax 56698 0
Email 56698 0
n.lannin@latrobe.edu.au
Contact person for public queries
Name 56699 0
Emma Schneider
Address 56699 0
Caulfield Hospital, 260 Kooyong Road, Caulfield, Victoria 3162
Country 56699 0
Australia
Phone 56699 0
+61 03 90767424
Fax 56699 0
Email 56699 0
e.schneider@alfred.org.au
Contact person for scientific queries
Name 56700 0
Emma Schneider
Address 56700 0
Caulfield Hospital, 260 Kooyong Road, Caulfield, Victoria 3162
Country 56700 0
Australia
Phone 56700 0
+61 03 90767424
Fax 56700 0
Email 56700 0
e.schneider@alfred.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseExtra upper limb practice after stroke: A feasibility study.2019https://dx.doi.org/10.1186/s40814-019-0531-5
N.B. These documents automatically identified may not have been verified by the study sponsor.