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Functional Electrical Stimulation(FES)+iPad-based Music Therapy in Stroke Rehabilitation

Examining the effect of FES+iPad-based music therapy on upper limb function and wellbeing outcomes for stroke survivors

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000344291
Enrollment
40
Registered
2018-03-07
Start date
2018-03-26
Completion date
Unknown
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This research study aims to look at the effects of combining music therapy with functional electrical stimulation on arm and hand function after stroke. Functional electrical stimulation (FES) is an evidence-based therapy that is widely used in stroke rehabilitation of the arm and hand. Music therapy allows people to engage in music-based exercises, such as playing an instrument, as part of their rehabilitation and therapy. In iPad-based music therapy, the instrument that is used is in the form of an iPad application. In this project, we will use “ThumbJam”; a touch-sensitive iOS application in which instrumental sounds and scales (combinations of notes) can be programmed according to the preference of the user. This study will examine the effect of combining FES and iPad-based music therapy (“FES+iPad-based music therapy”) as an addition to usual treatment, in comparison to usual treatment alone. It is important to note that FES may or may not already be part of usual treatment. The primary aim of this research is to examine whether the addition of FES+iPad-based music therapy will further improve the functional activity of the affected arm and hand of stroke survivors. The secondary aim of this research is to examine the effect of the addition FES+iPad-based music therapy on wellbeing outcomes such as self-efficacy, depression, anxiety and stress, in comparison to usual treatment.

Interventions

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.

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.

Sponsors

The University of Melbourne
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

Exclusion criteria

• Severe cognitive impairment • Impairment in receptive communication • Cardiac pacemaker • Hypersensitivity to electrical stimulation • Severe skin conditions • Epilepsy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026