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StrokeNCT06979050

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

A study testing The Ronnie Gardiner Method in people with Stroke, run by Göteborg University at 3 sites in Sweden.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
The Ronnie Gardiner Method
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
3 sitesSweden
Study dates
21 Jul 2025to 31 Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

3 sites in 1 country.

Sweden3 sites
  • Folkuniversitetet

    Gothenburg, 41309

  • Resurscentrum

    Karlstad

  • Neurologiska rehabiliteringskliniken

    Stockholm

Other trials in Sweden

About this study

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
Being tested
The Ronnie Gardiner Method
Keywords
Music-based intervention, Stroke rehabilitation, Ronnie Gardiner Method
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The Ronnie Gardiner MethodBehavioural

    Also called RGM

    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.

Study groups in NCT06979050
Study groupRoleWhat they receive
Music-based interventionExperimentalParticipants 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.
Receives: Behavioral: The Ronnie Gardiner Method
Waiting-listNo interventionWaiting list, receiving the same intervention after the final follow-up assessment three months post-intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (13)
  1. Concern about falling measured by the Falls Efficacy Scale-International (FES-I)

    FES-I is a tool used to assess a person's confidence in performing daily activities without falling. It consists of 16 questions that cover a range of activities, from walking and bathing to social interactions. The scale helps identify individuals who may have a fear of falling, which can impact their participation in everyday life.

    Minimum score is 16 points, maximum score is 64 points. A higher score indicates greater concern about falling, and it's commonly used in older adults or individuals at risk of falls to guide interventions aimed at improving balance and reducing fall risk.

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

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

    The test assesses the ability to recall a read text immediately after it is read aloud and after a few minutes, when another test is conducted (delayed recall).

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

  3. Cognitive flexibility and inhibitory control measured by the Victoria Stroop Test

    Measures cognitive flexibility, attention, and response inhibition. It involves naming the color of printed words that may or may not match the color they describe, requiring the individual to suppress automatic reading responses. The test is commonly used to assess executive function, particularly in individuals with neurological conditions. It includes three conditions, and outcomes include reaction time and number of errors. Higher interference scores indicate poorer inhibitory control.

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

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

    The Rey-Osterrieth Complex Figure Test is a neuropsychological assessment used to evaluate visuospatial abilities, memory, attention, and executive function. Individuals are asked to copy a complex geometric figure and later reproduce it from memory after a delay. It is commonly used to assess cognitive impairments in various neurological conditions. Scoring is based on accuracy and placement of figure components. Higher scores indicate better visuospatial memory and organizational performance.

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

  5. Physical performance measured by the Short Physical Performance Battery (SPPB)

    A clinical tool used to assess lower extremity function and mobility in older adults. It includes tests of balance, gait speed, and chair stands to evaluate physical performance. The SPPB is commonly used to predict disability, falls, and overall functional decline.

    Minimal score is 0 points, maximum score is 12 points. Higher score indicates better physical function.

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

  6. Functional mobility and gait performance measured by the 10-Meter Walk Test (10MWT)

    The 10-Meter Walk Test (10MWT) is a quick assessment used to measure walking speed over 10 meters at the individual's self-selected pace. It evaluates functional mobility, gait efficiency, and balance. The test is commonly used to monitor progress and predict functional outcomes in people with neurological or musculoskeletal conditions.

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

  7. Physical capacity including aerobic capacity and endurance measured by the 6-Minute Walk Test (6MWT)

    The 6-Minute Walk Test (6MWT) measures the distance an individual can walk at a self-paced speed over six minutes. It assesses aerobic capacity, endurance, and functional mobility. The test is widely used to evaluate cardiovascular and pulmonary function in clinical and rehabilitation settings. The test measures the distance a person can walk in six minutes on a flat, hard surface, typically a 30-meter course.

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

  8. Upper extremity function measured by The Observational Drinking Task Assessment

    The Observational Drinking Task Assessment is used to evaluate upper limb function, motor control, and coordination during a simulated drinking task. The individual is observed while reaching for, grasping, and bringing a cup to the mouth. It is often used in neurological rehabilitation to assess functional use of the affected arm.

    Minimal score is 0 points, maximal score is 15 points. Higher scores indicate worse outcome, i.e., more impairments in the upper extremity.

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

  9. Finger dexterity and fine motor skills measures by the 9-Hole Peg Test (9HPT)

    The 9-Hole Peg Test is a standard assessment used to measure finger dexterity and fine motor skills. The individual is required to place and remove pegs from a pegboard as quickly as possible. It is commonly used to assess hand function in individuals with neurological conditions, such as multiple sclerosis or stroke.

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

  10. Health-related quality of life and functional recovery after a stroke measured by the Stroke Impact Scale 16 (SIS-16)

    The Stroke Impact Scale 16 (SIS-16) is a self-reported questionnaire used to assess the health-related quality of life and functional recovery after a stroke. It consists of 16 items that measure various aspects of physical, emotional, and social functioning. The scale helps track recovery progress and guide rehabilitation in stroke survivors.

    Minimal score is 16 points, and maximum is 80. Higher score indicates a better function and lower impact on everyday life.

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

  11. Severity of depressive symptoms measured by the Montgomery-Åsberg Depression Rating Scale (MADRS)

    The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-administered assessment used to evaluate the severity of depressive symptoms. It consists of 10 items that assess mood, sleep, appetite, and other emotional and physical symptoms associated with depression. The MADRS is commonly used in clinical settings to monitor treatment progress and assess depression severity.

    Minumum score is 0 points, and maximum score is 60. Higher scores indicate more severe symptoms of depression.

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

  12. General health-realted quality of life measured by the Research and development (RAND) 36-item health survey

    The RAND-36 is a health survey used to assess an individual's overall health-related quality of life. It consists of 36 items that measure eight domains, including physical functioning, emotional well-being, social functioning, and general health perceptions. The RAND-36 is widely used in both clinical and research settings to evaluate health outcomes across various conditions.

    Minimal score is 0 points, maximal score is 100 points. Higher values indicate better self-reported health-related quality of life.

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

  13. Cost-effectiveness evaluated with the standardized European Quality of Life (EuroQol) questionnaire with 5 dimensions

    The EuroQol 5D 5L (EQ-5D-5L) is a standardized instrument used to assess health-related quality of life. It includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated on five levels of severity. The EQ-5D-5L is commonly used in clinical trials, healthcare evaluations, and to measure the impact of treatments on patients' well-being.

    Minimal score is 0 on a visual analogue scale, and 100 is maximum. A higher score indicates better health in general. Scores is used to evaluate an interventions cost-effectiveness.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2025
  2. Study start21 Jul 2025
  3. Primary completion15 Mar 2027 (estimated)
  4. Study completion31 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06979050
Sponsor's protocol ID
2025-01269-01
Other IDs
2025
Status last verified
May 2025
First submitted
6 May 2025
Last updated
3 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Upon completion of the study, data will be prepared and made available in accordance with Swedish data protection reulations and the University of Gothenburg's Rules for Research Data Management. In line with these regulations, data containing personal information will be deposited in the Swedish National Data Service repository under a "restricted access" model. Under this model, a description of the data (metadata) together with relevant documentation files will be openly published, while the actual data files will not be directly accessible. Researchers wishing to access the data must submit a request through the repository, and each request will be reviewed before access is granted.

Publications

  • Ghai S, Pohl P. 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. BMJ Open. 2026 Feb 4;16(2):e107178. doi: 10.1136/bmjopen-2025-107178.

    PubMed 41638729

Questions about this trial

What is this clinical trial studying?

A study testing The Ronnie Gardiner Method in people with Stroke, run by Göteborg University at 3 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Balance performance measured by the Mini Balance Evaluation Systems Test (Mini-BESTest) (time frame: At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06979050, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.

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