Skip to main content
OpenTrials
Completed

NCT Number: NCT02999997

Evaluation of Ronnie Gardiner Method 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:

1. dual task performance (motor-motor, and motor-cognitive) 2. level of physical activity, motor function and balance 3. cognitive function including memory and spatial function 4. health-related quality of life, fear of falling, and freezing of gait 5. qualitative interviews from focus group discussions

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Behavior Brain Diseases Central Nervous System Diseases Motor Activity Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neurological clinic, Linkoeping Universityhospital

Linköping, Östergötland County, 58185, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • parkinsonism of other origin, color blindness, severely impaired vision or hearing

Treatment and study plan

Ronnie Gardiner Method (RGM)

Behavioral

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.

Other names: In Sweden and Israel known as RGRM

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Dual-task cost (DTC)

    Time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months

    Measuring the difference between Timed Up and Go (TUG) single task and TUG cognitive and manual respectively

  2. Mini-BESTest (Balance Evaluation Systems Test)

    Time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months

    A balance test focusing on dynamic balance and can be conducted in 10-15 minutes.

  3. Four Step Square Test, FSST

    Time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months

    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.

  4. Berg Balance Scale

    Time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months

    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

  5. Chair stand 30 seconds

    Time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months

    Standing up and sitting down, hands crossed over chest, as many times as possible for 30 seconds.

  6. Montreal Cognitive Assessment (MoCA)

    Time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months

    Screening of cognitive function. License has been approved.

  7. Auditory memory test, direct and delayed

    Time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months

    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.

  8. Symbol Digit Modalities Test (SDMT)

    Time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months

    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.

  9. Victoria Stroop test

    Time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months

    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".

  10. Grooved Pegboard

    Time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months

    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.

  11. Trail Making Test A and B

    Time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months

    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.

  12. Rey complex figure

    Time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months

    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.

  13. WHODAS 2.0

    Time frame: Baseline

    A questionnaire based on the International Classification of Functioning (ICF) for assessing impairments and function.

  14. Freezing of gait questionnaire

    Time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months

    A questionnaire with questions about freezing of gait

  15. Parkinson's disease questionnaire 39 items (PDQ-39)

    Time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months

    A questionnaire for quality of life in people with Parkinson's disease. License as been approved.

  16. Falls Efficacy Scale International (FES-I)

    Time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months

    A questionnaire related to fear of falling.

  17. Actigraphy with GeneActiv Armband

    Time frame: Change from Baseline through study completion (at 12 weeks) and at 3 months

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Linkoeping

Other

Registry information

Official study 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

Acronym: RGM/PD

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 21, 2016
Registry last updated
May 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.