Condition category
Nervous System Diseases
Date applied
04/04/2017
Date assigned
05/04/2017
Last edited
06/04/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Petra Pohl

ORCID ID

http://orcid.org/0000-0002-3447-6547

Contact details

Rehabgruppen NSC
Dept of Rehabilitation and Dept of Medical and Health Sciences
Linköping University
Linköping
58185
Sweden
+46 725 629882
petra.pohl@liu.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT02999997

Protocol/serial number

RGM/PD

Study information

Scientific title

Evaluation of the Ronnie Gardiner Method regarding dual-task performance in Parkinson's disease

Acronym

Study hypothesis

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

Regional Ethical Review Board in Linköping, 16/06/2016, ref: 2016/179-31

Study design

Single-blind randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet (in Swedish only)

Condition

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

Phase

Drug names

Primary outcome measures

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.

Secondary outcome measures

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)

Overall trial start date

01/03/2016

Overall trial end date

31/12/2018

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

All

Gender

Both

Target number of participants

60

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/01/2017

Recruitment end date

31/08/2017

Locations

Countries of recruitment

Sweden

Trial participating centre

Rörelse & Hälsa
Neurorehab Region Östergötland
Linköping
58185
Sweden

Sponsor information

Organisation

The County Council of Östergötland

Sponsor details

Region Östergötland
Linköping
58191
Sweden
+46 10 103 0000
region@regionostergotland.se

Sponsor type

University/education

Website

www.regionostergotland.se

Funders

Funder type

Charity

Funder name

Henry and Margareta Ståhls Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Tornspiran Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Neuro Association

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Parkinson Disease Research Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal end of 2018.

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

Intention to publish date

31/12/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes