Evaluation of the Ronnie Gardiner Method in Individuals With Stroke in Late Phase of Recovery

Göteborg University

Status: Active, not recruiting

Conditions: Stroke

Treatments: Behavioral: The Ronnie Gardiner Method

Study type: Interventional

Funder types: Other

Identifiers

NCT06979050

2025-01269-01

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Music-based intervention

Experimental group

Description:

Participants randomized to the intervention group will receive the Ronnie Gardiner Method (RGM), a rhythm- and music-based training program, in group sessions led by a certified instructor. The intervention consists of 60-minute sessions, twice per week, for 12 consecutive weeks. The training incorporates coordinated movements, speech, and rhythm using visual symbols representing limbs and directions, performed to music with varying tempo and complexity. Exercises are designed to improve motor function, balance, coordination, and cognitive engagement. Sessions are conducted primarily in standing to optimize balance effects.

Treatment:

Behavioral: The Ronnie Gardiner Method

Waiting-list

No Intervention group

Description:

Waiting list, receiving the same intervention after the final follow-up assessment three months post-intervention.