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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Study type
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
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

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).

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
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
Name [1] 295966 0
Royal Perth Hospital Medical Research Foundation (RPH-MRF)
Address [1] 295966 0
Royal Perth Hospital Medical Research Foundation
PO Box 2323, East Perth WA 6892
Country [1] 295966 0
Primary sponsor type
University of Western Australia
University of Western Australia
35 Stirling Highway
Crawley WA 6009
Secondary sponsor category [1] 294852 0
Name [1] 294852 0
Address [1] 294852 0
Country [1] 294852 0

Ethics approval
Ethics application status
Ethics committee name [1] 297236 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 297236 0
Level 5, Colonial House
Royal Perth Hospital
Wellington Street, PERTH WA 6000
Ethics committee country [1] 297236 0
Date submitted for ethics approval [1] 297236 0
Approval date [1] 297236 0
Ethics approval number [1] 297236 0

Brief summary
This pilot study aims to investigate the effect of a novel mobile phone based music-motor therapy software application (app) on human motor control. There is considerable interest in using music therapy combined with movement as a way to change the brain and improve functional recovery following injury to the central nervous system. To date, current therapies incorporating movement and rhythmic cues (metronome or music) are effective at improving upper extremity motor control and gait in neurological disorders, including Parkinson’s Disease, Stroke, and Traumatic Brain Injury (TBI). However, these therapies have a number of limitations, including lack of feedback about motor responses in relation to the music, and lack of portability.

We have developed a novel mobile software application – GotRhythm – that uses mobiles and wireless wearable sensors to deliver music-motor therapy to patients with real time biofeedback. The proposed study will investigate the effectiveness of this new music-motor therapy app at improving motor control in patients following neurotrauma and and allow us to optimise future treatments for neurotrauma patients.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1607 1607 0 0
Attachments [2] 2689 2689 0 0

Principal investigator
Name 73418 0
A/Prof Christopher Etherton-Beer
Address 73418 0
Royal Perth Hospital
Service 1, Geriatric Medicine
197 Wellington Street
Country 73418 0
Phone 73418 0
Fax 73418 0
Email 73418 0
Contact person for public queries
Name 73419 0
A/Prof Christopher Etherton-Beer
Address 73419 0
Royal Perth Hospital
Service 1, Geriatric Medicine
197 Wellington Street
Country 73419 0
Phone 73419 0
Fax 73419 0
Email 73419 0
Contact person for scientific queries
Name 73420 0
A/Prof Christopher Etherton-Beer
Address 73420 0
Royal Perth Hospital
Service 1, Geriatric Medicine
197 Wellington Street
Country 73420 0
Phone 73420 0
Fax 73420 0
Email 73420 0

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