Evaluation of the Ronnie Gardiner Method in individuals with stroke in the late phase of recovery: a protocol for a single-blind multicentre randomised controlled trial.
Stroke is a prevalent neurological condition that frequently results in long-term disabilities and considerable societal costs. While existing rehabilitation approaches provide some benefits, residual motor impairments often persist and become permanent, leading to ongoing activity restrictions. Music-based intervention, such as the Ronnie Gardiner Method (RGM), adheres to best practice principles of stroke rehabilitation by simultaneously engaging motor, sensory, cognitive and emotional functions, potentially offering enhanced recovery outcomes. However, research examining its effectiveness in chronic stroke rehabilitation remains limited.
This multicentre, randomised controlled trial will recruit 84 community-dwelling individuals with chronic stroke over a 2-year period across four sites in Sweden. Participants will be randomly assigned to either an intervention group receiving RGM training (n=42) or a passive waitlist control group (n=42). Only the investigators and outcome assessors will remain blinded to group allocation. RGM training consists of 60 min group sessions twice weekly for 12 consecutive weeks. The primary outcome is to evaluate the effectiveness of RGM training on balance performance using the Mini-Balance Evaluation Systems Test. Secondary outcomes include assessment of gait function (10-Metre Walk Test, 6 min Walk Test, Short Physical Performance Battery), upper limb function (9-Hole Peg Test, Observational Drinking Task Assessment), cognitive abilities (Victoria Stroop Test, Rey Complex Figure Test, Memory Test), fear of falling (Falls Efficacy Scale-International) and stroke-related functional impact (Stroke Impact Scale-16). Broader health-related quality of life will be assessed using the RAND 36-Item Health Survey, EuroQol 5-Dimension 5-Level, and depressive symptoms will be measured with the Montgomery-Åsberg Depression Rating Scale. All outcomes will be assessed at baseline, postintervention and at a 3-month follow-up. Additional assessments will include qualitative evaluations of participants' and trainers' subjective experiences, cognitive screening (Montreal Cognitive Assessment) and postintervention enjoyment assessment (Physical Activity Enjoyment Scale).
Ethical approvals for the study have been obtained from the Swedish Ethical Review Authority (Dnr: 2025-01269-01 and Dnr: 2025-08232-02). The results will be disseminated via peer-reviewed journal publications, conference presentations and targeted communication with stakeholders and the media.
NCT06979050.
This multicentre, randomised controlled trial will recruit 84 community-dwelling individuals with chronic stroke over a 2-year period across four sites in Sweden. Participants will be randomly assigned to either an intervention group receiving RGM training (n=42) or a passive waitlist control group (n=42). Only the investigators and outcome assessors will remain blinded to group allocation. RGM training consists of 60 min group sessions twice weekly for 12 consecutive weeks. The primary outcome is to evaluate the effectiveness of RGM training on balance performance using the Mini-Balance Evaluation Systems Test. Secondary outcomes include assessment of gait function (10-Metre Walk Test, 6 min Walk Test, Short Physical Performance Battery), upper limb function (9-Hole Peg Test, Observational Drinking Task Assessment), cognitive abilities (Victoria Stroop Test, Rey Complex Figure Test, Memory Test), fear of falling (Falls Efficacy Scale-International) and stroke-related functional impact (Stroke Impact Scale-16). Broader health-related quality of life will be assessed using the RAND 36-Item Health Survey, EuroQol 5-Dimension 5-Level, and depressive symptoms will be measured with the Montgomery-Åsberg Depression Rating Scale. All outcomes will be assessed at baseline, postintervention and at a 3-month follow-up. Additional assessments will include qualitative evaluations of participants' and trainers' subjective experiences, cognitive screening (Montreal Cognitive Assessment) and postintervention enjoyment assessment (Physical Activity Enjoyment Scale).
Ethical approvals for the study have been obtained from the Swedish Ethical Review Authority (Dnr: 2025-01269-01 and Dnr: 2025-08232-02). The results will be disseminated via peer-reviewed journal publications, conference presentations and targeted communication with stakeholders and the media.
NCT06979050.