Short Term Effects of a Multimodal Intervention With RGM on Cognition in People With Parkinson's Disease.

NCT07863219 — Not applicable, Recruiting, 20 participants, University Ghent

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

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.

RegistryNCT07863219
StatusRecruiting
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, treatment
Enrollment20 (Estimated)
SponsorUniversity Ghent (Other)
ConditionsParkinson Disease (PD), Cognition, Quality of Life, Functional Mobility
InterventionsRonnie Gardiner Method (Other)
Datesstart 2026-08-01, primary completion 2026-12-20 (estimated), completion 2027-01-30 (estimated), first posted 2026-10-07, last updated 2026-10-07
Locations1 site in Belgium

Related Papers Related Patents Related Grants Related Experts
All trials for Parkinson Disease (PD) All trials for Cognition All trials of Ronnie Gardiner Method

-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.

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?

Expand all sections  ·  Collapse all

+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.

+Arms and interventions

ArmTypeInterventionsDescription
RGMExperimentalOther: Ronnie Gardiner Method10 weeks of RGM group training (1.5h/w) supplemented with home exercises and conventional care
  • Ronnie Gardiner Method (Other), also known as multimodal therapy, group therapy: 1. 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

+Outcome measures

Primary outcomes

  • change in cognition [From enrollment to the end of intervention at 10 weeks]: score on SCOPA-COG

Secondary outcomes

  • change in motor symptoms [From enrollment to the end of intervention at 10 weeks]: score of MDS-UPDRS III
  • change in balance and mobility [From enrollment to the end of intervention at 10 weeks]: score of MiniBESTest / Functional Gait Assessment
  • change in QOL [From enrollment to the end of intervention at 10 weeks]: score of PDQ39
  • Speech handicap Index [From enrollment to the end of intervention at 10 weeks]: score of perceived handicap - physical, functional and emotional
  • change in quality of voice (vowel formants, voice oncet time), motor speech and prosody [From enrollment to the end of intervention at 10 weeks]: 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
  • Change in maximum voluntary respiration rate [From enrollment up to 10 weeks of intervention]: maximum volontary respiration frequency

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.

+Locations (1)

FacilityCityCountryStatus
University Hospital GhentGhent, Oost-VlaanderenBelgiumRecruiting