Evaluation of Ronnie Gardiner Method in Individuals With Parkinson's Disease
- Conditions
- Parkinson Disease
- Interventions
- Behavioral: Ronnie Gardiner Method (RGM)
- Registration Number
- NCT02999997
- Lead Sponsor
- University Hospital, Linkoeping
- Brief 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. 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
- 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
- parkinsonism of other origin, color blindness, severely impaired vision or hearing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ronnie Gardiner Method (RGM) Ronnie Gardiner Method (RGM) Exercising two times/week according to the RGM program in groups of 15 participants (2 groups).
- Primary Outcome Measures
Name Time Method Timed Up and Go Cognitive (TUGcog) (motor-cognitive dual task) 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) 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 Outcome Measures
Name Time Method Mini-BESTest (Balance Evaluation Systems Test) 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.
Montreal Cognitive Assessment (MoCA) Change from Baseline through study completion (at 12 weeks) and at 3 months Screening of cognitive function. License has been approved.
Symbol Digit Modalities Test (SDMT) 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.
Grooved Pegboard 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.
Rey complex figure 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.
Berg Balance Scale 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
Chair stand 30 seconds 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.
Auditory memory test, direct and delayed 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.
Trail Making Test A and B 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.
WHODAS 2.0 Baseline A questionnaire based on the International Classification of Functioning (ICF) for assessing impairments and function.
Freezing of gait questionnaire Change from Baseline through study completion (at 12 weeks) and at 3 months A questionnaire with questions about freezing of gait
Falls Efficacy Scale International (FES-I) Change from Baseline through study completion (at 12 weeks) and at 3 months A questionnaire related to fear of falling.
Victoria Stroop test 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".
Parkinson's disease questionnaire 39 items (PDQ-39) 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.
Dual-task cost (DTC) 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
Four Step Square Test, FSST 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.
Actigraphy with GeneActiv Armband 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.
Trial Locations
- Locations (1)
Neurological clinic, Linkoeping Universityhospital
🇸🇪Linkoping, Ostergotland, Sweden