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

NCT06979050 | Active Not Recruiting

• 1 other identifier: 2025-01269-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

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.

Conditions

Stroke

Keywords

Music-based intervention; Stroke rehabilitation; Ronnie Gardiner Method

Outcome Measures

Primary Outcomes (1)

• Balance performance measured by the Mini Balance Evaluation Systems Test (Mini-BESTest)

  The mini-BESTest (Mini Balance Evaluation Systems Test) is a shortened version of the BESTest, designed to assess balance and functional mobility, especially in individuals with neurological or musculoskeletal conditions. It focuses on balance deficits across domains like postural control, gait, stability, and anticipatory responses. With 14 items compared to the original 36, the mini-BESTest is quicker to administer, making it more practical for clinical use. It evaluates four main balance systems: * Anticipatory Postural Adjustments: Preparing and adjusting posture for movements. * Reactive Postural Control: Responding to unexpected balance challenges. * Sensory Orientation: Using sensory input (like vision and proprioception) for balance. * Dynamic Gait: Stability and efficiency while walking, including maintaining balance during movement. Minimum score is 0 points, maximum score is 28 points. Higher scores indicate better balance control.

  At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up)

Secondary Outcomes (13)

• Concern about falling measured by the Falls Efficacy Scale-International (FES-I)

  At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up)

• Working memory measured by the Memory Test (Immediate and Delayed Recall)

  At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up)

• Cognitive flexibility and inhibitory control measured by the Victoria Stroop Test

  At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up)

• Visuospatial memory and organization measured by the Rey-Osterrieth Complex Figure Test

  At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up)

• Physical performance measured by the Short Physical Performance Battery (SPPB)

  At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up)

Other Outcomes (2)

• Various cognitive domains measured by the Montreal Cognitive Assessment (MoCA)

  Only at baseline

• Participants' enjoyment of the interventions measured by the Physical Activity Enjoyment Scale (PACES)

  After 12 weeks of treatment

Study Arms (2)

Music-based intervention

EXPERIMENTAL

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.

Behavioral: The Ronnie Gardiner Method

Waiting-list

NO INTERVENTION

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

Interventions

The Ronnie Gardiner Method 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.

Also known as: RGM

Music-based intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Göteborg University: lead
• Karlstad University: collaborator

Study Sites (3)

Folkuniversitetet

Gothenburg, 41309, Sweden

Location

Resurscentrum

Karlstad, Sweden

Location

Neurologiska rehabiliteringskliniken

Stockholm, Sweden

Location

Related Links

• Related Info

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Petra Pohl, PhD

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to group allocation. Neither participants nor intervention providers will be masked due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 18, 2025
• Study Start: July 21, 2025
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: October 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

SE (3)