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Trial registered on ANZCTR


Registration number
ACTRN12613000121763
Ethics application status
Not yet submitted
Date submitted
31/01/2013
Date registered
1/02/2013
Date last updated
12/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Developing new ways to minimise disability after stroke, a randomised controlled trial of Functional Electrical Stimulation (FES) of the arm and Mirror Therapy.
Scientific title
Among people admitted to inpatient rehabilitation wards following stroke does the use of FES combined with Mirror Therapy lead to improvements in activities in daily living compared with FES or Mirror Therapy alone.
Secondary ID [1] 281829 0
Nil
Universal Trial Number (UTN)
U1111-1138-8222
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 288187 0
Condition category
Condition code
Physical Medicine / Rehabilitation 288608 288608 0 0
Physiotherapy
Stroke 288617 288617 0 0
Ischaemic
Stroke 288618 288618 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly assigned to the FES group, Mirror Therapy group or the combined FES with Mirror therapy group.
The FES group will involve individually tailored progressive programmes beginning with a session of 20 minutes and progressing each day as tolerated. At the same time the participants will receive two half hour sessions of task specific training each day. The goal will be to have 30-minute FES sessions twice daily, concurrently with two 30 minute sessions of task-specific exercise, and the rest of the daily sessions will be limited to FES without specific exercises. The FES parameters will be set to run at a rate of 45Hz with a pulse width of 200 micro seconds using a synchronous current. The ramp up time of 1sec, ramp down time of 0.8sec and overall work:rest ratio of 8sec:8sec will be fixed throughout the study however session times will progress as tolerated. Surface electrode placement is reproducible using known landmarks of motor point anatomy used in EMG practical manuals.
The mirror therapy group will be provided with 30-minute mirror therapy sessions twice daily, in addition to two half hour sessions daily of task specific exercises. The mirror therapy sessions will involve progressively difficult functional tasks performed by the unaffected upper limb while attempting to mimic these tasks with the affected upper limb within the mirror-box.
The FES & Mirror therapy combined group will undergo 30-minute sessions twice daily, in addition to two half hour sessions daily of task specific exercises. These sessions will replicate the tasks performed within the mirror therapy group and the FES electrode placement will mimic that of the FES alone group.
The duration of treatment for each participant will continue throughout their stay within the Comprehensive Stroke Unit - approximately 4-6 weeks. FES and Mirror Therapy will be administered by a research physiotherapist in a group setting (one physiotherapist with up to four participants), while the two half hour sessions daily of task specific exercises will be administered by ward based allied health staff.
Intervention code [1] 286435 0
Rehabilitation
Comparator / control treatment
Each group will receive two half hour sessions of task specific training each day in addition to each groups specific intervention. The FES alone group in this study will act as the control.
Control group
Active

Outcomes
Primary outcome [1] 288761 0
Action Research Arm Test
- assesses upper limb function.
Timepoint [1] 288761 0
Immediately pre and post trial
Secondary outcome [1] 300918 0
1) Hospital Length of Stay
Timepoint [1] 300918 0
Immediately Post Trial
Secondary outcome [2] 300919 0
2) Disability Support use (Home care and Residential Aged Care)

- Each service used by participants upon discharge will be captured and compared accordingly.
Timepoint [2] 300919 0
Immediately Post Trial
Secondary outcome [3] 300920 0
3) Duration and intensity of in-patient Physiotherapy and Occupational Therapy
Timepoint [3] 300920 0
Immediately Post Trial
Secondary outcome [4] 300921 0
4) Extended Activities of Daily Living (Nottingham Extended Activities of Daily Living Scale (NEADL)
Timepoint [4] 300921 0
Immediately Post Trial
Secondary outcome [5] 300922 0
5) Cost effectiveness evaluation

While a full cost effectiveness evaluation is beyond the budget of this project proven costs of the programme will be collated and health costs accrued from hospitalisations (through NHI linked data) and GP contacts (from GP administrative data) will be examined in each group as a limited cost assessment
Timepoint [5] 300922 0
Post Trial

Eligibility
Key inclusion criteria
(a) Over 18 years; (b) Admitted to Waikato Hospital with a confirmed diagnosis of stroke; (c) Living in the community within the Hamilton area on admission to hospital; (d) Has a score of greater than 16/30 on Montreal Cognitive Assessment; and (e) Has an Action Research Arm Test (ARAT) score of <30/57
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clinicians may consider a patient unsuitable to enroll if they have any of the following: (a) Severe cognitive impairment (<16/30 on the Montreal Cognitive Assessment); (b) Severe or unstable cardiovascular disease (i.e. unstable angina, pacemaker fitted, dysrhythmia other than controlled atrial fibrillation); (c) Near-terminal disease (including advanced lung, heart, kidney, liver failure resistant to medical management); (d) Acute Musculoskeletal Disorder

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)
Participants admitted to Waikato Hospital Comprehensive Stroke Unit will be screened for inclusion into the study. Eligible patients will be approached to determine their willingness to participate in the trial. If they agree then they will be visited by a research assistant and informed consent will be obtained. Following this they will be randomised into one of three groups. Randomisation will be ascertained by a randomisation schedule held at a distant site. This schedule will be compiled by someone with no involvement in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule is generated ysing a thorough numeric list randomly generated within Microsoft Excel
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

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

Recruitment
Recruitment status
Not yet recruiting
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 outside Australia
Country [1] 4833 0
New Zealand
State/province [1] 4833 0
Hamilton

Funding & Sponsors
Funding source category [1] 286659 0
University
Name [1] 286659 0
University of Auckland
Address [1] 286659 0
12 Grafton Rd,
Grafton
1010
Auckland
Country [1] 286659 0
New Zealand
Primary sponsor type
Individual
Name
Dr John Parsons
Address
The Applied Ageing Research Group,
School of Nursing,
Faculty of Medical and Health Sciences,
The University of Auckland
Level 2, Building 505,
85 Park Road,
Grafton,
Auckland,
1142
Country
New Zealand
Secondary sponsor category [1] 285437 0
None
Name [1] 285437 0
Address [1] 285437 0
Country [1] 285437 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288730 0
Health and Disability Ethics Committees
Ethics committee address [1] 288730 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington
Ethics committee country [1] 288730 0
New Zealand
Date submitted for ethics approval [1] 288730 0
01/01/2013
Approval date [1] 288730 0
Ethics approval number [1] 288730 0

Summary
Brief summary
Stroke is a major public health challenge in New Zealand. As well as the personal burden carried by those with stroke, there is a considerable financial cost to the nation, for hospital, community and institutional care. As the population ages, the number affected by stroke is projected to increase significantly. Two important treatment modalities for maximising function after stroke is Mirror therapy and FES. Mirror therapy takes advantage of visual stimuli to regain function through motor imagery. Participants observe their unaffected limb performing a functional task while attempting to mimic that task on their affected side. FES is a relatively new treatment option for adults after stroke. FES involves electrical stimulation whilst undertaking specific tasks, such as applying electrical stimulation to an impaired arm, whilst attempting to lift a cup. Despite the encouraging results, FES does not form part of a standardised approach as evidence is incomplete and no protocols are available that allow FES to be readily employed by therapists and nurses. Further, there are no studies that evaluate the impact of using FES in people in the acute stages following stroke. This randomised controlled trial will seek to compare the impact between early intervention FES, Mirror Therapy and combined FES with Mirror therapy on 100 adults with impaired upper limbs following stroke. The study will explore the effect of these interventions on activities of daily living (such as writing letters, making a cup of tea and getting washed and dressed) as well as hospital length of stay. This study will not only allow a thorough and robust exploration of FES and Mirror Therapy, but moreover if successful allow the development of protocols to be used nationally and internationally and build capacity within the unit in both clinical skills and research.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37286 0
Dr John Parsons
Address 37286 0
The Applied Ageing Research Group,
School of Nursing,
Faculty of Medical and Health Sciences,
The University of Auckland
Level 2, Building 505,
85 Park Road,
Grafton,
Auckland,
1142
Country 37286 0
New Zealand
Phone 37286 0
+64 (0) 9 923 3935
Fax 37286 0
Email 37286 0
j.parsons@auckland.ac.nz
Contact person for public queries
Name 37287 0
Dr John Parsons
Address 37287 0
The Applied Ageing Research Group,
School of Nursing,
Faculty of Medical and Health Sciences,
The University of Auckland
Level 2, Building 505,
85 Park Road,
Grafton,
Auckland,
1142
Country 37287 0
New Zealand
Phone 37287 0
+64 (0) 9 923 3935
Fax 37287 0
Email 37287 0
j.parsons@auckland.ac.nz
Contact person for scientific queries
Name 37288 0
Dr John Parsons
Address 37288 0
The Applied Ageing Research Group,
School of Nursing,
Faculty of Medical and Health Sciences,
The University of Auckland
Level 2, Building 505,
85 Park Road,
Grafton,
Auckland,
1142
Country 37288 0
New Zealand
Phone 37288 0
+64 (0) 9 923 3935
Fax 37288 0
Email 37288 0
j.parsons@auckland.ac.nz

No information has been provided regarding IPD availability
Summary results
No Results