ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

U1111-1138-8222

Trial acronym

Linked study record

Health condition

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

Stroke

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Stroke

Ischaemic

Stroke

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]

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]

Action Research Arm Test
- assesses upper limb function.

Timepoint [1]

Immediately pre and post trial

Secondary outcome [1]

1) Hospital Length of Stay

Timepoint [1]

Immediately Post Trial

Secondary outcome [2]

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]

Immediately Post Trial

Secondary outcome [3]

3) Duration and intensity of in-patient Physiotherapy and Occupational Therapy

Timepoint [3]

Immediately Post Trial

Secondary outcome [4]

4) Extended Activities of Daily Living (Nottingham Extended Activities of Daily Living Scale (NEADL)

Timepoint [4]

Immediately Post Trial

Secondary outcome [5]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

15/02/2013

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Hamilton

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Auckland

Address [1]

12 Grafton Rd,
Grafton
1010
Auckland

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Health and Disability Ethics Committees

Ethics committee address [1]

Ministry of Health
 No 1 The Terrace
 PO Box 5013
 Wellington

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

01/01/2013

Approval date [1]

Ethics approval number [1]

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

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

Phone

+64 (0) 9 923 3935

Fax

j.parsons@auckland.ac.nz

Contact person for public queries

Name

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

Phone

+64 (0) 9 923 3935

Fax

j.parsons@auckland.ac.nz

Contact person for scientific queries

Name

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

Phone

+64 (0) 9 923 3935

Fax

j.parsons@auckland.ac.nz

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

Source	Title	Year of Publication	DOI
Embase	Mirror therapy for improving motor function after stroke.	2018	https://dx.doi.org/10.1002/14651858.CD008449.pub3

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically