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

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2018
INTERVENTION: 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. CONDITION: Stroke (cerebrovascular accident) ; ; SECONDARY OUTCOME: The DASS‐21 contains a set of 3 self‐report scales that are aimed at measuring the individuals’ level of depression, anxiety and stress. PRIMARY OUTCOME: 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. 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. 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. ; 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. ; 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
Epistemonikos ID: 86d15f80f7c4727fbd099bea2fb2ab2e6957407e
First added on: Aug 25, 2024