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Trial registered on ANZCTR


Registration number
ACTRN12617000488303
Ethics application status
Approved
Date submitted
20/03/2017
Date registered
4/04/2017
Date last updated
15/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
GotRhythm: A tailored music therapy and real-time biofeedback mobile phone app to promote rehabilitation following stroke
Scientific title
A tailored music therapy and real-time biofeedback mobile phone app (“GotRhythm”) to promote rehabilitation following stroke
Secondary ID [1] 291485 0
none
Universal Trial Number (UTN)
Trial acronym
none
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 302552 0
Condition category
Condition code
Stroke 302083 302083 0 0
Haemorrhagic
Stroke 302084 302084 0 0
Ischaemic
Physical Medicine / Rehabilitation 302103 302103 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: a novel mobile software application –“GotRhythm” – uses mobiles and wireless wearable sensors to deliver music-motor therapy to patients with real-time feedback of movement data to the patient via the application to enhance motivation and compliance. It incorporates individualised music, wearable sensors and biofeedback to deliver a simple and inexpensive rhythmic auditory stimulation (RAS) motor training protocol to patients. As a person completes training tasks, GotRhythm collects data relating to motion and movement accuracy and provides information on motor performance (via the application) that can be correlated with any physiological response elicited by the app. GotRhythm is capable of supporting a wide array of sensors to support a variety of physical modalities including both upper and lower limb tracking as well as gross and fine motor skills.

Location of intervention: The training will take place under supervision at the stroke rehabilitation clinic (either inpatient or outpatient) at the hospital at which the participant is a patient/outpatient. GotRhythm training will be tailored to the participant’s specific injury in consultation with the clinicians at the hospital at which they are a patient/outpatient (Bentley, Fiona Stanley or Fremantle Hospitals). Training will be in addition to the usual stroke rehabilitation programme recommended by their clinician throughout the study period. Usual stroke rehabilitation does not include rhythmic auditory stimulation (RAS) and these patients will not receive any GotRhythm training.

The procedures, mode of delivery, materials and who does the intervention: A series of participant-specific movement tasks focusing on different body parts will be created to match the rehabilitation goals of each patient. Movements such as grasping, knee, elbow and wrist flexion and extension, as well as walking, can all be accommodated within the GotRhythm system. Patients will wear non-intrusive sensors on the relevant body part that link wirelessly to the app. An allied health professional in the rehabilitation clinic will control the GotRhythm training by assigning a suitable rhythm (beats per minute) for each participant, using songs chosen by the participant. Beat speed will be adjusted to suit each patient’s abilities during a session and also progressively over the 6-week intervention period.

Frequency of intervention and assessments/data collected: Participants in the intervention group will receive 6-weeks of intervention consisting of a supervised, 20minute music entrainment session conducted three (3) times each week for six (6) weeks. There will be 2 blocks of therapy:
1. Therapy block 1 - 3 x 20mins/wk x 3 weeks = total of 9 sessions
2. Therapy block 2 - 3 x 20mins/wk x 3 weeks = total of 9 sessions
Participants will therefore receive a total of 18 sessions (= 360mins of therapy in total). Each session is identical, and there are no differences between the sessions in Therapy Blocks 1 & 2.
It is likely these sessions will be conducted on Monday/Wednesday/Friday of each week. Block 2 will follow straight on from Block 1 (following the schedule of sessions).
Participants will be assessed at i) baseline (0 weeks), ii) mid intervention point (+3 weeks) and iii) the end of the intervention period (+6 weeks). The mid-point assessment will be conducted after the final session of Block 1.

We will look at i) compliance with the intervention ii) improvement in targeted motor task and iii) generalisation of sensory motor control.

The data collected, and schedule of assessments is summarised in Figure 1 (uploaded as attachment on ANZCTR registration form)
Intervention code [1] 297553 0
Rehabilitation
Comparator / control treatment
Control group: Participants in this group will receive their usual stroke rehabilitation therapy during the trial period, but will not have any GotRhythm music-motor therapy sessions.
Control group
Active

Outcomes
Primary outcome [1] 301521 0
Compliance with the intervention: GotRhythm records the length of time each patient engages with the app.

We will track each participant’s progress and their adherence to their rehabilitation program by recording minutes engaged with the app for each therapy session. This will give total minutes engaged for Therapy Block 1 and Therapy Block 2 and thus a Total compliance measure ([minutes engaged Block 1+minutes engaged Block 2]/360mins)
Timepoint [1] 301521 0
Patients will be assessed at 3 weeks (end of Therapy Block 1) and at the end of the intervention period (6 weeks) (end of Therapy Block 2).
Secondary outcome [1] 332917 0
Sensory motor control: The Fugl-Meyer Assessment of Motor Recovery is a stroke-specific, performance based impairment index that evaluates motor functioning, balance, sensation and joint functioning in patients following stroke.

Timepoint [1] 332917 0
Patients will be assessed at baseline, 3 weeks and at the end of the intervention period (6 weeks).
Secondary outcome [2] 332985 0
Targeted motor task: We will assess music-motor synchrony using the in-built measures of GotRhythm by measuring the proportion of motor task repetitions that match app metronome.
Timepoint [2] 332985 0
Patients will be assessed at baseline, 3 weeks and at the end of the intervention period (6 weeks).

Eligibility
Key inclusion criteria
neurologically impaired adults – specifically, patients who have suffered an acute stroke and are attending outpatients at the stroke clinic.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Excluded from study if:
a) <18 years age
b) pregnant
c) unstable co-morbid medical or psychiatric disease

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)
Sealed opaque envelopes will be used for randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Consenting participants will be randomised using a computer generated sequence of numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2017
Actual
2/06/2017
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 7695 0
Bentley Health Service - Bentley
Recruitment hospital [2] 10892 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [3] 10893 0
Fremantle Hospital and Health Service - Fremantle
Recruitment postcode(s) [1] 15616 0
6102 - Bentley
Recruitment postcode(s) [2] 22656 0
6150 - Murdoch
Recruitment postcode(s) [3] 22657 0
6160 - Fremantle

Funding & Sponsors
Funding source category [1] 295966 0
Charities/Societies/Foundations
Name [1] 295966 0
Royal Perth Hospital Medical Research Foundation (RPH-MRF)
Country [1] 295966 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
University of Western Australia
35 Stirling Highway
Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 294852 0
None
Name [1] 294852 0
Address [1] 294852 0
Country [1] 294852 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297236 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 297236 0
Ethics committee country [1] 297236 0
Australia
Date submitted for ethics approval [1] 297236 0
21/12/2016
Approval date [1] 297236 0
17/03/2017
Ethics approval number [1] 297236 0
RGS0000000044

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1607 1607 0 0
/AnzctrAttachments/372590(v28-03-2017-14-39-47)-Figure 1 GotRhythm Schedule of assessments.docx (Supplementary information)
Attachments [2] 2689 2689 0 0
/AnzctrAttachments/372590-Figure 1 GotRhythm Schedule of Assessments (Amended).doc (Supplementary information)

Contacts
Principal investigator
Name 73418 0
A/Prof Christopher Etherton-Beer
Address 73418 0
Royal Perth Hospital
Service 1, Geriatric Medicine
197 Wellington Street
PERTH WA 6000
Australia
Country 73418 0
Australia
Phone 73418 0
+61892240295
Fax 73418 0
+61892240364
Email 73418 0
[email protected]
Contact person for public queries
Name 73419 0
Christopher Etherton-Beer
Address 73419 0
Royal Perth Hospital
Service 1, Geriatric Medicine
197 Wellington Street
PERTH WA 6000
Australia
Country 73419 0
Australia
Phone 73419 0
+61892240295
Fax 73419 0
+61892240364
Email 73419 0
[email protected]
Contact person for scientific queries
Name 73420 0
Christopher Etherton-Beer
Address 73420 0
Royal Perth Hospital
Service 1, Geriatric Medicine
197 Wellington Street
PERTH WA 6000
Australia
Country 73420 0
Australia
Phone 73420 0
+61892240295
Fax 73420 0
+61892240364
Email 73420 0
[email protected]

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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes 2022 Neuroscience Insights Vol 17:1-6 Hankinson... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA Tailored Music-Motor Therapy and Real-Time Biofeedback Mobile Phone App ('GotRhythm') to Promote Rehabilitation Following Stroke: A Pilot Study.2022https://dx.doi.org/10.1177/26331055221100587
N.B. These documents automatically identified may not have been verified by the study sponsor.