Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000344291
Ethics application status
Approved
Date submitted
5/02/2018
Date registered
7/03/2018
Date last updated
7/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Functional Electrical Stimulation(FES)+iPad-based Music Therapy in Stroke Rehabilitation
Scientific title
Examining the effect of FES+iPad-based music therapy on upper limb function and wellbeing outcomes for stroke survivors
Secondary ID [1] 293431 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke (cerebrovascular accident) 306225 0
Condition category
Condition code
Physical Medicine / Rehabilitation 305329 305329 0 0
Other physical medicine / rehabilitation
Stroke 305873 305873 0 0
Haemorrhagic
Stroke 305874 305874 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study seeks to examine the effect of adding FES+iPad-based music therapy to usual treatment on the functional activity of the paretic arm, and wellbeing outcomes on stroke survivors, in comparison to those receiving usual treatment alone.

This study will take place across 5 rehabilitation units in Sydney, Australia. 40 participants will be allocated to the usual treatment only (control group) or usual treatment plus FES+iPad-based music therapy (intervention group) by block randomization.

The 20 participants in the intervention group will receive 20 FES+iPad-based music therapy sessions as an addition to their usual care. These sessions will be facilitated by a Registered Music Therapist. The materials required for the intervention include an electrical stimulation machine (with electrode pads and an external trigger for on/off periods of stimulation), an iPad containing the music making application “ThumbJam”, and a rectangular cushion for forearm support (for the participant to rest their arm on). This intervention uses electrical currents to produce contractions in muscle fibres to assist the stroke survivor to engage in repetitively movement whilst playing the iPad-based instrument. In this study, participants will be given the opportunity to choose at least 2 out of the 3 music making streams to engage with during electrical stimulation of the paretic arm; free improvisation, directed improvisation and/or song learning. Participants will also be asked to fill in a practice log based on a monthly calendar – this will be provided by the Registered Music Therapist. It is important to note that all participants will receive the intervention from the SAME Registered Music Therapist. The mode of delivery for this individual intervention is face to face.

Participants will receive 20 x 45 minute FES+iPad-based music therapy sessions over 4 weeks (5 days per week). Participants will be encouraged to engage in self-directed practice between sessions. The intervention will take place at the participating rehabilitation units (hospitals) in Sydney, Australia.

The FES strength will be be different for each participant - the reason for this is that the purpose of the use of FES is to obtain an appropriate muscle contraction for wrist/finger extension. This level will be determined by the treating physiotherapist/occupational therapist of the participant. It is important to note that prior to commencing the study, participants may already be engaging in FES (as part of their standard care).

The FES will be applied for the duration of the session (with triggered on/off periods) as tolerated by the participant. I.e. if the participant is only able to tolerate on/off triggered FES for 15 minutes, FES will cease at this time. If participants are able to tolerate a longer duration (e.g. up to 45 minutes) of on/off triggered FES, then the FES will remain. It is important to note that there will be short breaks within the session itself as participants will be transitioning between engaging in at least two out of the three music making streams (Free improvisation, Directed Improvisation and/or Song Learning).

Each participant will be encouraged to engage in self-directed practice between sessions and on completion of the four week (20 session) intervention. This will then be reviewed at the three month post test (3 months post intervention completion). Participants will be expected to engage in all sessions and will be asked to keep a practice log. The template practice log will be given to the participant during session one.

Intervention code [1] 300065 0
Rehabilitation
Intervention code [2] 300440 0
Treatment: Other
Comparator / control treatment
The control treatment is "usual care" at the hospital.

Both groups will undergo inpatient rehabilitation, which will continue as usual, including usual arm therapy. Usual arm therapy [for stroke rehabilitation] is delivered as 3 hours per week of group therapy and one to two hours per week of individual therapy, plus some independent practice. For very weak muscles (i.e. Grade 0, 1 and 2), usual arm therapy involves providing an environment where repetitive active movements could be attempted using gravity-eliminated positions, decreasing friction and shortening the lever arm of the limb. For stronger muscles (i.e. Grade 3 or 4) usual arm therapy includes progressive resistance exercise and task specific training.
Control group
Active

Outcomes
Primary outcome [1] 304484 0
The primary outcome is the functional activity of the paretic upper limb activity.

The primary outcome measure for testing functional activity will be the Motor Assessment Scale, using the upper limb items (UL-MAS). The motor assessment scale contains a total of 8 items that assess the functional activity of the individual after stroke onset. For the purpose of this study, the 3 items of upper limb function will be assessed, including; upper arm function, hand movements and advanced hand activities.
Timepoint [1] 304484 0
Pre intervention period (0 weeks), post intervention period (4 weeks - primary timepoint) and 3-month follow up (4 months - endpoint)
Primary outcome [2] 305014 0
Manual Muscle Tests of the upper limb (MMT-UL) The MMT-UL are used to measure upper limb strength. For the purpose of this study, 5 items will be included in this assessment: shoulder flexors, elbow extensors, elbow flexors, wrist extensors and wrist flexors.
Timepoint [2] 305014 0
Pre intervention period (0 weeks), post intervention period (4 weeks - primary timepoint) and 3-month follow up (4 months - endpoint)
Primary outcome [3] 305015 0
The 9-Hole-Peg test (9HPT). The 9HPT is used to measure finger dexterity. This test consists of one task: as quickly as possible, the participant is to take pegs from one container (one-by-one) and then place each peg into a hole on the board.
Timepoint [3] 305015 0
Pre intervention period (0 weeks), post intervention period (4 weeks - primary timepoint) and 3-month follow up (4 months - endpoint)
Secondary outcome [1] 342115 0
The DASS-21 contains a set of 3 self-report scales that are aimed at measuring the individuals’ level of depression, anxiety and stress.
Timepoint [1] 342115 0
Pre intervention period (0 weeks), post intervention period (4 weeks) and 3-month follow up (4 months)
Secondary outcome [2] 343871 0
The Stroke Self-Efficacy Questionnaire (SSEQ) is a self-report measure used to assess the stroke survivors’ level of confidence in functional performance post stroke.
Timepoint [2] 343871 0
Pre intervention period (0 weeks), post intervention period (4 weeks) and 3-month follow up (4 months)

Eligibility
Key inclusion criteria
To be included in this study, participants need to meet the following criteria:
• Medical diagnosis of stroke
• Recruitment within 4 weeks of stroke onset
• Inpatient status at one of the included hospital recruitment sites
• Upper limb hemiparesis secondary to stroke
• Less than grade 3 level of strength (inclusive) in at least 3 out of 5 muscle groups of the affected upper limb (shoulder flexors, elbow extensors, elbow flexors, wrist extensors and wrist flexors)
• Able to follow 2-stage commands
• Predicted length of stay to be a minimum of 4 weeks from recruitment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Severe cognitive impairment
• Impairment in receptive communication
• Cardiac pacemaker
• Hypersensitivity to electrical stimulation
• Severe skin conditions
• Epilepsy

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)
As this is a multi-site randomized controlled trial (RCT), participants will be randomly allocated to the control (usual treatment only) or experimental (usual treatment plus FES+iPad-based Music Therapy) via block randomization.

The allocation concealment will be done using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomization is a technique that seeks to reduce bias and equally allocate participants (in blocks) to each group (control and experimental), particularly if the sample size of the study is small. Five different randomization sequences (one for each of the 5 study sites) will be generated with a block size of 4.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/03/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9814 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 9815 0
St George Hospital - Kogarah
Recruitment hospital [3] 9816 0
Lady Davidson Private Hospital - North Turramurra
Recruitment hospital [4] 9817 0
Metropolitan Rehabilitation Hospital - Petersham
Recruitment hospital [5] 9818 0
Mt Wilga Private Hospital - Hornsby
Recruitment postcode(s) [1] 18595 0
2031 - Randwick
Recruitment postcode(s) [2] 18596 0
2217 - Kogarah
Recruitment postcode(s) [3] 18597 0
2074 - North Turramurra
Recruitment postcode(s) [4] 18598 0
2049 - Petersham
Recruitment postcode(s) [5] 18599 0
2077 - Hornsby

Funding & Sponsors
Funding source category [1] 298856 0
University
Name [1] 298856 0
University of Melbourne
Country [1] 298856 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
The University of Melbourne
Parkville VIC 3010
Country
Australia
Secondary sponsor category [1] 298061 0
None
Name [1] 298061 0
n/a
Address [1] 298061 0
n/a
Country [1] 298061 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299077 0
South East Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 299077 0
Ethics committee country [1] 299077 0
Australia
Date submitted for ethics approval [1] 299077 0
12/10/2017
Approval date [1] 299077 0
11/01/2018
Ethics approval number [1] 299077 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2451 2451 0 0
/AnzctrAttachments/374040-2018.01.11 NEAF Ethics Approval 17-256.pdf (Ethics approval)
Attachments [2] 2452 2452 0 0
/AnzctrAttachments/374040-PISCF - FES+iPadbasedMT CTR.pdf (Participant information/consent)
Attachments [3] 2454 2454 0 0
/AnzctrAttachments/374040-Protocol - FES+iPad-basedMT 23Nov17 .pdf (Protocol)

Contacts
Principal investigator
Name 79218 0
Dr Jeanette Tamplin
Address 79218 0
The University of Melbournce
234 St Kilda Road, Southbank
Victoria 3006
AUSTRALIA
Country 79218 0
Australia
Phone 79218 0
+61 3 9035 6787
Fax 79218 0
Email 79218 0
[email protected]
Contact person for public queries
Name 79219 0
Tanya Marie Silveira
Address 79219 0
The University of Melbournce
234 St Kilda Road, Southbank
Victoria 3006
AUSTRALIA
Country 79219 0
Australia
Phone 79219 0
+61 0431235587
Fax 79219 0
Email 79219 0
[email protected]
Contact person for scientific queries
Name 79220 0
Tanya Marie Silveira
Address 79220 0
The University of Melbournce
234 St Kilda Road, Southbank
Victoria 3006
AUSTRALIA
Country 79220 0
Australia
Phone 79220 0
+61 0431235587
Fax 79220 0
Email 79220 0
[email protected]

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