Short Term Effects of a Multimodal Intervention With RGM on Cognition in People With Parkinson's Disease.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Ghent
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Ronnie Gardiner Method
Other intervention1. 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
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: RGMExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
change in cognition
score on SCOPA-COG
Time frame
From enrollment to the end of intervention at 10 weeksSecondary outcomes
1
change in motor symptoms
score of MDS-UPDRS III
Time frame
From enrollment to the end of intervention at 10 weeks2
change in balance and mobility
score of MiniBESTest / Functional Gait Assessment
Time frame
From enrollment to the end of intervention at 10 weeks3
change in QOL
score of PDQ39
Time frame
From enrollment to the end of intervention at 10 weeks4
Speech handicap Index
score of perceived handicap - physical, functional and emotional
Time frame
From enrollment to the end of intervention at 10 weeksSponsors and contacts
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Source ClinicalTrials.gov