Parkinson DiseaseRGM/PDNCT02999997
Evaluation of Ronnie Gardiner Method in Individuals With Parkinson's Disease
A study testing Ronnie Gardiner Method (RGM) in people with Parkinson Disease, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
Parkinson's disease (PD) is typically associated with cognitive and movement related functional disabilities. One commonly described cognitive complaint is the ability to do several things simultaneously, defined as dual or multiple tasking. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Ronnie Gardiner Method (RGM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2017to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's disease, stage 1,5 to 4 on the Hoehn \& Yahr scale, community dwelling, stable medication, being able to walk at least 10 meters, being able to transport to the intervention facility, being able to follow instructions in Swedish
Who cannot join
- parkinsonism of other origin, color blindness, severely impaired vision or hearing
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Neurological clinic, Linkoeping Universityhospital
Linköping, Östergötland County, 58185
About this study
Official title: Randomized Controlled Trial to Evaluate the Rhythm and Music Based Rehabilitation Method the Ronnie Gardiner Method Regarding Dual-task in Individuals With Parkinson's Disease
Parkinson's disease (PD) is typically associated with cognitive and movement related functional disabilities. One commonly described cognitive complaint is the ability to do several things simultaneously, defined as dual or multiple tasking. The Ronnie Gardiner Method (RGM) is a rhythm and music based rehabilitation intervention that includes components that will train this ability specifically in addition to postural control, motor learning, movement ability and general cognitive function. The aim with the present randomized controlled single-blinded trial is to evaluate the RGM with main focus on dual-task performance, compared to a control group, in individuals with PD. The control group will continue with everyday activities, including ordinary exercise activities, with no additional activity. Both groups will be evaluated pre-, post-, and after 3 months post intervention. Following outcome measures will be analyzed:
- dual task performance (motor-motor, and motor-cognitive)
- level of physical activity, motor function and balance
- cognitive function including memory and spatial function
- health-related quality of life, fear of falling, and freezing of gait
- qualitative interviews from focus group discussions
Read the detailed description
Patients with Parkinson's disease at the neurological department of University Hospital of Linköping are included and randomized to either the rhythm and music based rehabilitation method Ronnie Gardiner Method or to a control group with no other activity other than everyday activities including habitual exercise. Timed Up and Go (TUG) cognitive and TUG manual will be used to evaluate dual-task performance. The intervention will take place twice weekly for twelve weeks in a neurological rehabilitation facility, and will be led by a highly skilled physiotherapist with ten years of practice from the Ronnie Gardiner Method.
- Conditions
- Parkinson Disease
- Being tested
- Ronnie Gardiner Method (RGM)
- Keywords
- Physical therapy modalities, Dual-task performance, Parkinson's disease, Active music therapy, Physical activity
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ronnie Gardiner Method (RGM)Behavioural
Also called In Sweden and Israel known as RGRM
RGM includes functional exercises consisting of cognitively challenging multi-task exercises. The exercises are performed sitting down or standing up with weight shifting exercises. The practitioner projects unique symbols shaped as red or blue hands and feet on the wall in specific 'choreoscores' of 2-8 bars. Red symbolizes left side of the body, blue the right side. Each symbol is accompanied with a certain movement and sound code. To the sound of rhythmical music the participants follow the symbols beat by beat, performing the movements and pronouncing the word. The exercises are progressed by increasing the tempo of the music, or by using more symbols. The practitioner uses a shirt with the color red on one side, and blue on the other side, in order to facilitate for the participants.
| Study group | Role | What they receive |
|---|---|---|
| Ronnie Gardiner Method (RGM) | Experimental | Exercising two times/week according to the RGM program in groups of 15 participants (2 groups). Receives: Behavioral: Ronnie Gardiner Method (RGM) |
| Control group | No intervention | Participants in the control group are instructed to live their ordinary life. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go Cognitive (TUGcog) (motor-cognitive dual task)
Time in seconds to complete the following sequence: stand up from a chair, walk 3 meters, turn, walk back to the chair and sit down with the addition of counting backwards with 7 from 100, 90, 80, 70, 60, or 50. Number of errors are noted. Higher speed indicated better function.
Measured: Change from Baseline through study completion (at 12 weeks) and at 3 months
Timed Up and Go manual (TUG manual) (motor-motor dual task)
Time in seconds to complete the following sequence: stand up from a chair, walk 3 meters, turn, walk back to the chair and sit down with the additional task to carry a tray with two glasses of water. Higher speed indicates better function.
Measured: Change from Baseline through study completion (at 12 weeks) and at 3 months
Secondary outcomes (17)
Dual-task cost (DTC)
Measuring the difference between Timed Up and Go (TUG) single task and TUG cognitive and manual respectively
Measured: Change from Baseline through study completion (at 12 weeks) and at 3 months
Mini-BESTest (Balance Evaluation Systems Test)
A balance test focusing on dynamic balance and can be conducted in 10-15 minutes.
Measured: Change from Baseline through study completion (at 12 weeks) and at 3 months
Four Step Square Test, FSST
Patient steps over four canes set-up like a cross on the floor with the tips of the canes facing together. At the start of the test, the patient stands on the upper left square (in Square 1, facing Square 2). The stepping sequence is (clockwise): Square 1, Square 2, Square 4, Square 3, return to Square 1 with the feet. Then (counterclockwise): Back to Square 3, Square 4, Square 2, and end in Square 1 with both feet.
Measured: Change from Baseline through study completion (at 12 weeks) and at 3 months
Berg Balance Scale
Static and dynamic activities of varying difficulty are performed. Item-level scores range from 0-4, determined by ability to perform the assessed activity. Item scores are summed. Maximum score = 56
Measured: Change from Baseline through study completion (at 12 weeks) and at 3 months
Chair stand 30 seconds
Standing up and sitting down, hands crossed over chest, as many times as possible for 30 seconds.
Measured: Change from Baseline through study completion (at 12 weeks) and at 3 months
Montreal Cognitive Assessment (MoCA)
Screening of cognitive function. License has been approved.
Measured: Change from Baseline through study completion (at 12 weeks) and at 3 months
Auditory memory test, direct and delayed
A text is read to the patient. The patient is then required to reproduce the text as exactly as possible, and then again after appr. 10 minutes.
Measured: Change from Baseline through study completion (at 12 weeks) and at 3 months
Symbol Digit Modalities Test (SDMT)
A code key is presented to the patient where each code key represents a number between 1 and 9. The patient is then required to solve as many codes as possible in 90 seconds.
Measured: Change from Baseline through study completion (at 12 weeks) and at 3 months
Victoria Stroop test
Colored words are presented to the patient but in a different color than the word says, eg. the word BLUE appears in the color red and the patient is required to say "red", and not read the word "blue".
Measured: Change from Baseline through study completion (at 12 weeks) and at 3 months
Grooved Pegboard
The patient is required to move a number of metal sticks from one side to another as fast as possible. A measure of fine motor control.
Measured: Change from Baseline through study completion (at 12 weeks) and at 3 months
Trail Making Test A and B
The patient is required to draw a line between the numbers 1 to 25 (A), and between the numbers 1 to 13 and vary to the letters A to L, i.e. 1-A-2-B-3-C, etc, without lifting the pen from the paper.
Measured: Change from Baseline through study completion (at 12 weeks) and at 3 months
Rey complex figure
The patient is required to copy a figure twice: the first time from a model in front of him/her; the second time without the model by memory only.
Measured: Change from Baseline through study completion (at 12 weeks) and at 3 months
WHODAS 2.0
A questionnaire based on the International Classification of Functioning (ICF) for assessing impairments and function.
Measured: Baseline
Freezing of gait questionnaire
A questionnaire with questions about freezing of gait
Measured: Change from Baseline through study completion (at 12 weeks) and at 3 months
Parkinson's disease questionnaire 39 items (PDQ-39)
A questionnaire for quality of life in people with Parkinson's disease. License as been approved.
Measured: Change from Baseline through study completion (at 12 weeks) and at 3 months
Falls Efficacy Scale International (FES-I)
A questionnaire related to fear of falling.
Measured: Change from Baseline through study completion (at 12 weeks) and at 3 months
Actigraphy with GeneActiv Armband
Actigraphy is a method to evaluate physical activity in a research person´s normal life. GeneActiv is used to record number of steps daily but also time spent lying and standing which will give information about the activity.
Measured: Change from Baseline through study completion (at 12 weeks) and at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionApr 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petra Pohl, University Hospital, Linkoeping
- Investigators
- Petra Pohl, PhD, RPT, Principal investigator, University Hospital, Linkoeping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999997
- Sponsor's protocol ID
- LUH-4865
- Acronym
- RGM/PD
- Status last verified
- May 2018
- First submitted
- 10 Dec 2016
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
PubMed 36602886
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Evaluate the Rhythm and Music Based Rehabilitation Method the Ronnie Gardiner Method Regarding Dual-task in Individuals With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02999997
- Acronym / sponsor ID
- RGM/PD / LUH-4865
- Conditions
- Parkinson Disease
- Keywords
- Physical therapy modalities, Dual-task performance, Parkinson's disease, Active music therapy, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 21 Dec 2016 (estimated)
- 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.
Parkinson's disease (PD) is typically associated with cognitive and movement related functional disabilities. One commonly described cognitive complaint is the ability to do several things simultaneously, defined as dual or multiple tasking. The Ronnie Gardiner Method (RGM) is a rhythm and music based rehabilitation intervention that includes components that will train this ability specifically in addition to postural control, motor learning, movement ability and general cognitive function. The aim with the present randomized controlled single-blinded trial is to evaluate the RGM with main focus on dual-task performance, compared to a control group, in individuals with PD. The control group will continue with everyday activities, including ordinary exercise activities, with no additional activity. Both groups will be evaluated pre-, post-, and after 3 months post intervention. Following outcome measures will be analyzed:
- dual task performance (motor-motor, and motor-cognitive)
- level of physical activity, motor function and balance
- cognitive function including memory and spatial function
- health-related quality of life, fear of falling, and freezing of gait
- qualitative interviews from focus group discussions
Detailed description
Patients with Parkinson's disease at the neurological department of University Hospital of Linköping are included and randomized to either the rhythm and music based rehabilitation method Ronnie Gardiner Method or to a control group with no other activity other than everyday activities including habitual exercise. Timed Up and Go (TUG) cognitive and TUG manual will be used to evaluate dual-task performance. The intervention will take place twice weekly for twelve weeks in a neurological rehabilitation facility, and will be led by a highly skilled physiotherapist with ten years of practice from the Ronnie Gardiner Method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ronnie Gardiner Method (RGM) | Experimental | Behavioral: Ronnie Gardiner Method (RGM)Exercising two times/week according to the RGM program in groups of 15 participants (2 groups). |
| Control group | No intervention | –Participants in the control group are instructed to live their ordinary life. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Parkinson's disease, stage 1,5 to 4 on the Hoehn \& Yahr scale, community dwelling, stable medication, being able to walk at least 10 meters, being able to transport to the intervention facility, being able to follow instructions in Swedish
Key exclusion criteria (1 listed)
- parkinsonism of other origin, color blindness, severely impaired vision or hearing
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 Method (RGM)Also: In Sweden and Israel known as RGRMRGM includes functional exercises consisting of cognitively challenging multi-task exercises. The exercises are performed sitting down or standing up with weight shifting exercises. The practitioner projects unique symbols shaped as red or blue hands and feet on the wall in specific 'choreoscores' of 2-8 bars. Red symbolizes left side of the body, blue the right side. Each symbol is accompanied with a certain movement and sound code. To the sound of rhythmical music the participants follow the symbols beat by beat, performing the movements and pronouncing the word. The exercises are progressed by increasing the tempo of the music, or by using more symbols. The practitioner uses a shirt with the color red on one side, and blue on the other side, in order to facilitate for the participants. | Behavioural | Ronnie Gardiner Method (RGM) |
Primary outcome
Timed Up and Go Cognitive (TUGcog) (motor-cognitive dual task)
Time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months
Time in seconds to complete the following sequence: stand up from a chair, walk 3 meters, turn, walk back to the chair and sit down with the addition of counting backwards with 7 from 100, 90, 80, 70, 60, or 50. Number of errors are noted. Higher speed indicated better function.
Timed Up and Go manual (TUG manual) (motor-motor dual task)
Time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months
Time in seconds to complete the following sequence: stand up from a chair, walk 3 meters, turn, walk back to the chair and sit down with the additional task to carry a tray with two glasses of water. Higher speed indicates better function.
17 secondary outcomes
Dual-task cost (DTC)
Time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months
Mini-BESTest (Balance Evaluation Systems Test)
Time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months
Four Step Square Test, FSST
Time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months
Berg Balance Scale
Time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months
Chair stand 30 seconds
Time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months
Montreal Cognitive Assessment (MoCA)
Time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months
Auditory memory test, direct and delayed
Time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months
Symbol Digit Modalities Test (SDMT)
Time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months
Victoria Stroop test
Time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months
Grooved Pegboard
Time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months
Trail Making Test A and B
Time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months
Rey complex figure
Time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months
WHODAS 2.0
Time frame: Baseline
Freezing of gait questionnaire
Time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months
Parkinson's disease questionnaire 39 items (PDQ-39)
Time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months
Falls Efficacy Scale International (FES-I)
Time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months
Actigraphy with GeneActiv Armband
Time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Derived from this study: PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
- Derived from this study: PubMed 36602886Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
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. This study is not recruiting at the moment.
Petra Pohl, PhD, RPT principal investigator
University Hospital, Linkoeping
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 (RGM) in people with Parkinson Disease, run by University Hospital, Linkoeping at 1 site in Sweden.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 2 May 2018. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go Cognitive (TUGcog) (motor-cognitive dual task) (time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02999997, which also lists 2 linked publications.
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 2 May 2018.