Effects of the Ronnie Gardiner Method - A randomized controlled trial on Parkinson's disease

ISRCTN	ISRCTN85547604
DOI	https://doi.org/10.1186/ISRCTN85547604
ClinicalTrials.gov (NCT)	NCT02999997
Protocol serial number	RGM/PD
Sponsor	The County Council of Östergötland
Funders	Henry and Margareta Ståhls Foundation, Tornspiran Foundation, The Neuro Association, Parkinson Disease Research Foundation

Submission date: 04/04/2017
Registration date: 05/04/2017
Last edited: 03/03/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Parkinson’s disease (PD) is a common movement disorder, affecting approximately 120,000 people in the UK. It is a lifelong condition, which involves the gradual loss of nerve cells (neurons) in a part of the brain called the substantia nigra. These neurons are normally responsible for producing dopamine, a chemical messenger (neurotransmitter) which carries signals around the brain that help to coordinate movement. In people suffering from PD, these neurons gradually die over time, causing the level of dopamine in the brain to gradually fall. As the levels of dopamine become lower, the brain is unable to coordinate movement as effectively, causing abnormal movements such as stiffness, tremor (uncontrollable shaking) and slowness of movement (bradykinesia). As these symptoms worsen, patients often avoid movement and physical activity, for fear of falling, which can greatly impact on quality of life. The aim of this study is to evaluate the new rhythm and music based therapy program Ronnie Gardiner Method, created by Swedish musician Ronnie Gardiner, with the main focus on dual-task performance (doing two things at once).

Who can participate?
People with Parkinson's disease, diagnosed by a movement disorder specialist, in the community of Linköping, Sweden.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group attend the study centre to take part in the Ronnie Gardiner Method exercise program. This consists of planned, structured, repetitive, and purposive tasks performed to the beat of rhythmical music twice a week for 12 weeks in one hour sessions (total 24 sessions). Those in the second group do not attend any extra activities, and continue with their ordinary exercises and activities. Participants in both groups are followed up after three months.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Rörelse & Hälsa (Sweden)

When is the study starting and how long is it expected to run for?
March 2016 to December 2018

Who is funding the study?
The County Council of Östergötland (Sweden)
The Neuro Association (Sweden)
The Parkinson Disease Research Foundation (Sweden)
The Ståhls Foundation (Sweden)
The Tornspiran Foundation (Sweden)

Who is the main contact?
Dr Petra Pohl

Contact information

Dr Petra Pohl
Scientific

Rehabgruppen NSC
Dept of Rehabilitation and Dept of Medical and Health Sciences
Linköping University
Linköping
58185
Sweden

ORCID ID	0000-0002-3447-6547
Phone	+46 725 629882
Email	petra.pohl@liu.se

Study information

Primary study design	Interventional
Study design	Single-blind randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Evaluation of the Ronnie Gardiner Method regarding dual-task performance in Parkinson's disease
Study objectives	1. Participating in the rhythm and music based therapy program Ronnie Gardiner Method will improve the ability to perform simultaneous motor and cognitive tasks in people with Parkinson's disease 2. The program will improve cognitive function (memory, executive function, speed) 3. The program will have a positive effect on psychological wellbeing and reduce fear of falling 4. The program will improve postural stability 5. The program will enhance increased daily physical activity and reduce sedentary behaviour
Ethics approval(s)	Regional Ethical Review Board in Linköping, 16/06/2016, ref: 2016/179-31
Health condition(s) or problem(s) studied	Parkinson's disease
Intervention	Participants are randomised to one of two groups. Intervention group: The intervention is based on the rhythm and music based therapy program Ronnie Gardiner Method (RGM), containing planned, structured, repetitive, and purposive tasks. The program includes complex multicomponent movements and cognitive challenges performed to rhythmic music. The leader projects for this method unique symbols in the shape of red or blue hands and feet. In all, there are 19 symbols, each symbol with a specific movement and unique name. When the symbols appear, the participants must make a certain movement and simultaneously speak the correct name in a loud voice (i.e., dual-tasking). Mostly the exercises are performed standing up, leading to weight-bearing positions, eg. shifting weight from right to left leg while stretching arms, challenging the postural stability. The single exercises last for appr. 3 minutes, i.e., as long as the music lasts. One 1 hour session contains up to 10 different songs, allowing for time to repeat the movements (motor learning). The participants are encouraged to practice some movements at home to their favorite music in between the sessions. The exercises are continuously progressing with higher tempo and more challenging exercises. The intervention is performed twice weekly for 12 weeks in groups of 15 participants due to size of the intervention facility. The intervention is led by two certified RGM leaders who are also highly skilled registered physiotherapists. The sessions lasts for one hour each, a total of 24 sessions. After each session the leaders register attendance, any adverse events, and intensity achieved, in a structured report. Control group: Participants will not attend to any extra activity, but are allowed to continue their everyday life, including therapies or exercises. Both groups will be re-assessed within two weeks after the intervention period of 12 weeks, and again after another three months for a long term follow up. The assessments involve the same cognitive and physical tests and questionnaires as the pre-assessment, as well as wearing the actigraph armband for seven days.
Intervention type	Behavioural
Primary outcome measure(s)	Motor-cognitive dual-task performance measured with Timed-Up-and-Go test while subtracting 7 from 100, 90, or 80 at baseline, after 12 weeks, and at 3 months post-intervention.
Key secondary outcome measure(s)	1. Balance is assessed using the Berg Balance Scale and Mini-BESTest, at baseline, after 12 weeks, and at 3 months post-intervention 2. Mobility is assessed using the Chair-stand test and Four-Step-Square-Test (FSST) at baseline, post-intervention (after 12 weeks), and at 3 months post-intervention 3. Cognitive function is assessed using the Montreal Cognitive Assessment, MoCA (C) (multiple cognitive domains); Symbol Digit Modalities test (attention); Rey Complex Figure (visuospatial skills); Victoria Stroop test and Trails A and B test (executive function); Grooved Pegboard (motor speed); and memory (instant and recalled) at baseline, post-intervention (after 12 weeks), and at 3 months post-intervention 4. Sedentary behaviour and physical activity levels are assessed using GENEActive actigraphy, worn for 7 days at baseline, post-intervention (after 12 weeks), and at 3 months post-intervention 5. Attendance, adverse events and intensity achieved are assessed using a structured report completed by the leaders after each session in the intervention group 6. Psychological wellbeing is assessed using the Parkinson's Disease Questionnaire, 39 items (PDQ-39) at baseline, post-intervention (after 12 weeks), and at 3 months post-intervention 7. Fear of falling is assessed using Falls Efficacy Scale International, Swedish version (FES-I) at baseline, post-intervention (after 12 weeks), and at 3 months post-intervention 8. Participants experiences of participating in the intervention group is assessed by face-to-face interviews and focus groups with 5 participants in each group within one week post-intervention (after 12 weeks)
Completion date	21/03/2018

Eligibility

Participant type(s)	Patient
Age group	All
Lower age limit	18 Years
Upper age limit	75 Years
Sex	All
Target sample size at registration	60
Total final enrolment	54
Key inclusion criteria	1. Diagnosed Parkinson's disease living in the community, stage 1.5 - 3 on H & Y scale 2. Age 18-75 3. Able to walk at least 10 m with or without walking aid 4. No colour blindness 5. Must be able to see and hear with or without aids
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/01/2017
Date of final enrolment	17/09/2017

Locations

Countries of recruitment

Sweden

Study participating centre

Rörelse & Hälsa

Neurorehab
Region Östergötland
Linköping
58185
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from petra.pohl@liu.se

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2020	03/03/2020	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

03/03/2020: Publication reference added.
03/05/2019: The following changes were made:
1. The recruitment end date was updated from 31/08/2017 to 17/09/2017.
2. The overall trial end date was updated from 31/12/2018 to 21/03/2018.
3. The total final enrolment was added.
02/05/2019: No publications found, verifying study status with principal investigator.