Clinical trial NCT06979050: Evaluation of the Ronnie Gardiner Method in Individuals With Stroke in Late Phase of Recovery
Official title: Evaluation of the Ronnie Gardiner Method in Individuals With Stroke in Late Phase of Recovery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Music-based intervention
Stroke rehabilitation
Ronnie Gardiner Method
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Karlstad University
First posted: 2025-05-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stroke is a common condition that often leads to long-term disabilities, significantly affecting individuals' quality of life and imposing substantial societal costs. There is growing evidence that physical rehabilitation can improve motor function, well-being, and quality of life even in the chronic phase after stroke. In recent years, rhythm- and music-based interventions have gained increasing attention as promising tools in neurorehabilitation. The Ronnie Gardiner Method (RGM) is a structured, music-based training method that engages motor, sensory, cognitive, and emotional functions simultaneously. While preliminary studies have shown positive effects of RGM in individuals with Parkinson's disease, there is limited research on its impact in stroke rehabilitation, particularly in the chronic phase.

This randomized controlled multicenter study aims to evaluate the effects of RGM training in individuals aged 18 and older who are more than six months post-stroke. Participants will be randomly assigned to either an intervention group receiving RGM training twice per week for 12 weeks, or to a passive control group. The primary outcome is balance, assessed by the Mini-BESTest. Secondary outcomes include gait, upper limb function, cognitive abilities such as working memory and divided attention, and health-related quality of life. Additionally, qualitative data will be collected to explore participants' and trainers' experiences regarding motivation, engagement, and perceived impact on daily participation. The study is expected to provide valuable evidence on the clinical usefulness of RGM in chronic stroke rehabilitation and its potential to be implemented as part of community-based, cost-effective rehabilitation programs.


Eligibility criteria: Inclusion Criteria:

* Community-dwelling individuals with stroke that occurred \> 6 months ago
* Cognitive ability corresponding to at least 25 out of 30 points on the Montreal Cognitive Assessment (MoCA)
* Functional disability corresponding to a Modified Rankin Scale (mRS) score of 2-3
* No assistance required for daily activities during participation (e.g., can independently travel to measurement/training sites and use the restroom)
* Ability to stand for 2 minutes without support and walk 10 meters with or without assistive devices, but without supervision

Exclusion Criteria:

* Severe visual and/or hearing impairments that would interfere with study participation
* Participation in regular sessions with RGM after August 2024
* Previous experience playing a musical instrument (defined as practicing \>1 hour/week in the past 10 years)
* A score of less than 25 on the Montreal Cognitive Assessment (MoCA)

Primary outcomes:
measure: Balance performance measured by the Mini Balance Evaluation Systems Test (Mini-BESTest)
timeFrame: At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up)
Secondary outcomes:
measure: Concern about falling measured by the Falls Efficacy Scale-International (FES-I)
timeFrame: At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up)
measure: Working memory measured by the Memory Test (Immediate and Delayed Recall)
timeFrame: At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up)
measure: Cognitive flexibility and inhibitory control measured by the Victoria Stroop Test
timeFrame: At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up)
measure: Visuospatial memory and organization measured by the Rey-Osterrieth Complex Figure Test
timeFrame: At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up)
measure: Physical performance measured by the Short Physical Performance Battery (SPPB)
timeFrame: At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up)
measure: Functional mobility and gait performance measured by the 10-Meter Walk Test (10MWT)
timeFrame: At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up)
measure: Physical capacity including aerobic capacity and endurance measured by the 6-Minute Walk Test (6MWT)
timeFrame: At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up)
measure: Upper extremity function measured by The Observational Drinking Task Assessment
timeFrame: At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up)
measure: Finger dexterity and fine motor skills measures by the 9-Hole Peg Test (9HPT)
timeFrame: At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up)
measure: Health-related quality of life and functional recovery after a stroke measured by the Stroke Impact Scale 16 (SIS-16)
timeFrame: At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up)
measure: Severity of depressive symptoms measured by the Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up)
measure: General health-realted quality of life measured by the Research and development (RAND) 36-item health survey
timeFrame: At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up)
measure: Cost-effectiveness evaluated with the standardized European Quality of Life (EuroQol) questionnaire with 5 dimensions
timeFrame: At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up)
Other outcomes:
measure: Various cognitive domains measured by the Montreal Cognitive Assessment (MoCA)
timeFrame: Only at baseline
measure: Participants' enjoyment of the interventions measured by the Physical Activity Enjoyment Scale (PACES)
timeFrame: After 12 weeks of treatment
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