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

NCT ID: NCT06979050

Last Updated: 2025-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-21

Study Completion Date

2028-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Outcome assessors will be blinded to group allocation. Neither participants nor intervention providers will be masked due to the nature of the intervention.

Study Groups

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Music-based intervention

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.

Group Type EXPERIMENTAL

The Ronnie Gardiner Method

Intervention Type BEHAVIORAL

The intervention involves participants performing coordinated movements while saying specific cue words, synchronized to rhythmic music. The exercises are guided by a visual notation system consisting of 19 colored symbols that represent different body parts and movements. Red symbols indicate movements on the left side of the body, while blue symbols represent the right side. Each symbol corresponds to a specific movement and verbal cue. Exercises are typically performed standing to maximize balance effects and are accompanied by rhythmic, often popular, music to enhance engagement and motivation. Complexity can be increased by adjusting the tempo of the music or combining multiple symbols. Training sessions are conducted in groups, led by certified instructors, twice per week for 12 weeks (60 minutes per session), with an additional home-based practice session each week.

Waiting-list

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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The Ronnie Gardiner Method

The intervention involves participants performing coordinated movements while saying specific cue words, synchronized to rhythmic music. The exercises are guided by a visual notation system consisting of 19 colored symbols that represent different body parts and movements. Red symbols indicate movements on the left side of the body, while blue symbols represent the right side. Each symbol corresponds to a specific movement and verbal cue. Exercises are typically performed standing to maximize balance effects and are accompanied by rhythmic, often popular, music to enhance engagement and motivation. Complexity can be increased by adjusting the tempo of the music or combining multiple symbols. Training sessions are conducted in groups, led by certified instructors, twice per week for 12 weeks (60 minutes per session), with an additional home-based practice session each week.

Intervention Type BEHAVIORAL

Other Intervention Names

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RGM

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karlstad University

OTHER

Sponsor Role collaborator

Göteborg University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Petra Pohl, PhD

Role: PRINCIPAL_INVESTIGATOR

Göteborg University

Locations

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Folkuniversitetet

Gothenburg, , Sweden

Site Status

Resurscentrum

Karlstad, , Sweden

Site Status

Neurologiska rehabiliteringskliniken

Stockholm, , Sweden

Site Status

Countries

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Sweden

Related Links

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Other Identifiers

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2025-01269-01

Identifier Type: -

Identifier Source: org_study_id

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