Parkinson Disease (PD)NCT07863219
Short Term Effects of a Multimodal Intervention With RGM on Cognition in People With Parkinson's Disease.
A study testing Ronnie Gardiner Method in people with Parkinson Disease (PD) and Cognition, run by University Ghent at 1 site in Belgium.
Trial summary
The goal of this clinical trial is to learn if the Ronnie Gardiner Method (RGM) works to improve cognitive functions in adults with Parkinson's disease (early to mid-stage). It will also learn about the secondary effects on speech, mobility, balance, and mood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease (PD), Cognition, Quality of Life
- What is being tested?
- Ronnie Gardiner Method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Aug 2026to 30 Jan 2027
- 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
- diagnosis of idiopathic Parkinson's disease
- safe, independent mobility and participation (Hoehn and Yahr stages 1-3)
- a stable dopaminergic medication regimen for at least 4 weeks prior to study participation
- willingness and ability to participate in a 10-week intervention program
- willingness to participate in the study (signing of informed consent)
Who cannot join
- Presence of other neurological or severe psychiatric conditions that could interfere with participation or the interpretation of results (e.g., substance use disorder, severe depression, psychosis)
- Severe visual or hearing impairments that limit the ability to follow group instructions as determined by a physician.
- Physical limitations that inhibit safe participation in moderate-to-vigorous exercise or group rehabilitation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Ghent
Ghent, Oost-Vlaanderen, 9000
Wim De Wilde, MSc, +32 472 57 58 08, Wim.dewilde@ugent.be
Sanne Stegen, dr., +32 485 50 70 82, sanne.stegen@ugent.be
About this study
Official title: Short-term Effects of an Intervention Consisting of 10 RGM (Ronnie Gardiner Method) Training Sessions on Cognitive Functions in Individuals With Early- to Mid-stage Parkinson's Disease.
The goal of this clinical trial is to learn if the Ronnie Gardiner Method (RGM) works to improve cognitive functions in adults with Parkinson's disease (early to mid-stage). It will also learn about the secondary effects on speech, mobility, balance, and mood.
The main questions it aims to answer are:
- Does a 10-week RGM intervention improve cognitive aspects, speech (indirectly through improved breathing), mobility, and balance in participants with Parkinson's disease?
- How do participants experience the intensity, difficulty, and emotional impact of the RGM sessions?
Read the detailed description
The Ronnie Gardiner Method (RGM) is a cheerful, structured, multi-sensory brain exercise method that utilizes rhythm and music to stimulate movement, speech, and cognition. RGM makes playful use of rhythm, music, movement, speech, hearing, sight, and touch. During practice, the participant reads the symbols and 'translates' them into the corresponding movement, which is performed to the rhythm of the music. Preliminary research suggests RGM may have added value in promoting mobility, cognition, and well-being in neurological patients (https://www.tandfonline.com/doi/full/10.1080/09638288.2024.2392037#d1e1192).
The RGM exercise series for which participants are registering is integrated in the "Fit en Actief group classes" organized by the Ghent Flemish Parkinson League - in collaboration with Ghent University Rehabilitation Sciences and Physiotherapy.
The classes will take place from October to December 2026 (10 weeks), with exercises taking place once a week for 1.5 hours (on Thursdays) in the practical classrooms of the Rehabilitation Sciences and Physiotherapy program (UH Ghent, B3). In addition to the exercise sessions themselves, participants will be asked to perform home exercises twice a week for 15 minutes.
Before and after the exercise series, participants will be invited to take a pre- and post-test including administrative data, cognition, motor symptoms, balance, QOL. The training process (home exercises, experiences) will be inventoried by temporary questionnaires.
Afterwards, participants will be surveyed regarding changes in medication during the exercise series, changes in the frequency or content of (physio)therapy, and perceived changes in attention, memory, and planning.
- Being tested
- Ronnie Gardiner Method
- Keywords
- Ronnie Gardiner Method, multimodal therapy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ronnie Gardiner MethodOther
Also called multimodal therapy, group therapy
- Warm-up (10 min): light rhythmic movements to music; activation of coordination and attention.
- RGM Block 1 (30 min): cognitive-motor exercises incorporating color, sound, and movement elements (bilateral).
- Strength or interval segment (10 min): short strength/conditioning exercises (Tabata style) alternating between 20 seconds of activity and 20 seconds of rest. The exercises focus on strengthening postural muscles, improving rotation, encouraging weight shifting, and initiating movement quickly (the 4 principles of the PWR! concept).
- 10-minute break
- RGM Block 2 (30 min): cognitive-motor exercises incorporating color, sound, and movement elements (bilateral).
- Cool-down (10 min): relaxation, breathing, evaluation.
Cognitive component During the sessions, executive functions, attention, and processing speed are challenged and practiced through dual-task situations, pattern recognition, and auditory response tasks.
Home exercises After each session, participants are gi
| Study group | Role | What they receive |
|---|---|---|
| RGM | Experimental | 10 weeks of RGM group training (1.5h/w) supplemented with home exercises and conventional care Receives: Other: Ronnie Gardiner Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in cognition
score on SCOPA-COG
Measured: From enrollment to the end of intervention at 10 weeks
Secondary outcomes (6)
change in motor symptoms
score of MDS-UPDRS III
Measured: From enrollment to the end of intervention at 10 weeks
change in balance and mobility
score of MiniBESTest / Functional Gait Assessment
Measured: From enrollment to the end of intervention at 10 weeks
change in QOL
score of PDQ39
Measured: From enrollment to the end of intervention at 10 weeks
Speech handicap Index
score of perceived handicap - physical, functional and emotional
Measured: From enrollment to the end of intervention at 10 weeks
change in quality of voice (vowel formants, voice oncet time), motor speech and prosody
Praat-score (a free, open-source computer program) Motor Speech Profile - score (vocal tremor, diadochokinetic rates, and pitch/formant transitions) Loudness, intonation and speech intelligibility during reading ("The North Wind and the Sun") - 3 minutes of spontaneous speech
Measured: From enrollment to the end of intervention at 10 weeks
Change in maximum voluntary respiration rate
maximum volontary respiration frequency
Measured: From enrollment up to 10 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start1 Aug 2026
- Primary completion20 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dirk Cambier, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863219
- Sponsor's protocol ID
- ONZ-2026-0146
- Status last verified
- Oct 2026
- First submitted
- 9 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects of an Intervention Consisting of 10 RGM (Ronnie Gardiner Method) Training Sessions on Cognitive Functions in Individuals With Early- to Mid-stage Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT07863219
- Acronym / sponsor ID
- ONZ-2026-0146
- Keywords
- Ronnie Gardiner Method, multimodal therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if the Ronnie Gardiner Method (RGM) works to improve cognitive functions in adults with Parkinson's disease (early to mid-stage). It will also learn about the secondary effects on speech, mobility, balance, and mood.
The main questions it aims to answer are:
- Does a 10-week RGM intervention improve cognitive aspects, speech (indirectly through improved breathing), mobility, and balance in participants with Parkinson's disease?
- How do participants experience the intensity, difficulty, and emotional impact of the RGM sessions?
Detailed description
The Ronnie Gardiner Method (RGM) is a cheerful, structured, multi-sensory brain exercise method that utilizes rhythm and music to stimulate movement, speech, and cognition. RGM makes playful use of rhythm, music, movement, speech, hearing, sight, and touch. During practice, the participant reads the symbols and 'translates' them into the corresponding movement, which is performed to the rhythm of the music. Preliminary research suggests RGM may have added value in promoting mobility, cognition, and well-being in neurological patients (https://www.tandfonline.com/doi/full/10.1080/09638288.2024.2392037#d1e1192).
The RGM exercise series for which participants are registering is integrated in the "Fit en Actief group classes" organized by the Ghent Flemish Parkinson League - in collaboration with Ghent University Rehabilitation Sciences and Physiotherapy.
The classes will take place from October to December 2026 (10 weeks), with exercises taking place once a week for 1.5 hours (on Thursdays) in the practical classrooms of the Rehabilitation Sciences and Physiotherapy program (UH Ghent, B3). In addition to the exercise sessions themselves, participants will be asked to perform home exercises twice a week for 15 minutes.
Before and after the exercise series, participants will be invited to take a pre- and post-test including administrative data, cognition, motor symptoms, balance, QOL. The training process (home exercises, experiences) will be inventoried by temporary questionnaires.
Afterwards, participants will be surveyed regarding changes in medication during the exercise series, changes in the frequency or content of (physio)therapy, and perceived changes in attention, memory, and planning.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RGM | Experimental | Other: Ronnie Gardiner Method10 weeks of RGM group training (1.5h/w) supplemented with home exercises and conventional care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- diagnosis of idiopathic Parkinson's disease
- safe, independent mobility and participation (Hoehn and Yahr stages 1-3)
- a stable dopaminergic medication regimen for at least 4 weeks prior to study participation
- willingness and ability to participate in a 10-week intervention program
- willingness to participate in the study (signing of informed consent)
Key exclusion criteria (3 listed)
- Presence of other neurological or severe psychiatric conditions that could interfere with participation or the interpretation of results (e.g., substance use disorder, severe depression, psychosis)
- Severe visual or hearing impairments that limit the ability to follow group instructions as determined by a physician.
- Physical limitations that inhibit safe participation in moderate-to-vigorous exercise or group rehabilitation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ronnie Gardiner MethodAlso: multimodal therapy, group therapy1. Warm-up (10 min): light rhythmic movements to music; activation of coordination and attention. 2. RGM Block 1 (30 min): cognitive-motor exercises incorporating color, sound, and movement elements (bilateral). 3. Strength or interval segment (10 min): short strength/conditioning exercises (Tabata style) alternating between 20 seconds of activity and 20 seconds of rest. The exercises focus on strengthening postural muscles, improving rotation, encouraging weight shifting, and initiating movement quickly (the 4 principles of the PWR! concept). 4. 10-minute break 5. RGM Block 2 (30 min): cognitive-motor exercises incorporating color, sound, and movement elements (bilateral). 6. Cool-down (10 min): relaxation, breathing, evaluation. Cognitive component During the sessions, executive functions, attention, and processing speed are challenged and practiced through dual-task situations, pattern recognition, and auditory response tasks. Home exercises After each session, participants are gi | Other | RGM |
Primary outcome
change in cognition
Time frame: From enrollment to the end of intervention at 10 weeks
score on SCOPA-COG
6 secondary outcomes
change in motor symptoms
Time frame: From enrollment to the end of intervention at 10 weeks
change in balance and mobility
Time frame: From enrollment to the end of intervention at 10 weeks
change in QOL
Time frame: From enrollment to the end of intervention at 10 weeks
Speech handicap Index
Time frame: From enrollment to the end of intervention at 10 weeks
change in quality of voice (vowel formants, voice oncet time), motor speech and prosody
Time frame: From enrollment to the end of intervention at 10 weeks
Change in maximum voluntary respiration rate
Time frame: From enrollment up to 10 weeks of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Preliminary research suggests that RGM may offer added value in promoting mobility, cognition, and emotional well-being in neurological patientsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ronnie Gardiner Method in people with Parkinson Disease (PD) and Cognition, run by University Ghent at 1 site in Belgium.
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 3 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: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Contact Wim De Wilde, MSc (+32 472 57 58 08, Wim.dewilde@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in cognition (time frame: From enrollment to the end of intervention at 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2026.