Evaluation of Ronnie Gardiner Method in Individuals With Parkinson's Disease

Parkinson Disease Clinical Trial

— RGM/PD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02999997
• Other study ID #: LUH-4865
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: May 2018

Study information

• Verified date: May 2018
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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 information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: May 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Behavioral:
• Ronnie Gardiner Method (RGM)
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.

Locations

Country	Name	City	State
Sweden	Neurological clinic, Linkoeping Universityhospital	Linkoping	Ostergotland

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Baseline through study completion (at 12 weeks) and at 3 months
Primary	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.	Change from Baseline through study completion (at 12 weeks) and at 3 months
Secondary	Dual-task cost (DTC)	Measuring the difference between Timed Up and Go (TUG) single task and TUG cognitive and manual respectively	Change from Baseline through study completion (at 12 weeks) and at 3 months
Secondary	Mini-BESTest (Balance Evaluation Systems Test)	A balance test focusing on dynamic balance and can be conducted in 10-15 minutes.	Change from Baseline through study completion (at 12 weeks) and at 3 months
Secondary	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.	Change from Baseline through study completion (at 12 weeks) and at 3 months
Secondary	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	Change from Baseline through study completion (at 12 weeks) and at 3 months
Secondary	Chair stand 30 seconds	Standing up and sitting down, hands crossed over chest, as many times as possible for 30 seconds.	Change from Baseline through study completion (at 12 weeks) and at 3 months
Secondary	Montreal Cognitive Assessment (MoCA)	Screening of cognitive function. License has been approved.	Change from Baseline through study completion (at 12 weeks) and at 3 months
Secondary	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.	Change from Baseline through study completion (at 12 weeks) and at 3 months
Secondary	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.	Change from Baseline through study completion (at 12 weeks) and at 3 months
Secondary	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".	Change from Baseline through study completion (at 12 weeks) and at 3 months
Secondary	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.	Change from Baseline through study completion (at 12 weeks) and at 3 months
Secondary	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.	Change from Baseline through study completion (at 12 weeks) and at 3 months
Secondary	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.	Change from Baseline through study completion (at 12 weeks) and at 3 months
Secondary	WHODAS 2.0	A questionnaire based on the International Classification of Functioning (ICF) for assessing impairments and function.	Baseline
Secondary	Freezing of gait questionnaire	A questionnaire with questions about freezing of gait	Change from Baseline through study completion (at 12 weeks) and at 3 months
Secondary	Parkinson's disease questionnaire 39 items (PDQ-39)	A questionnaire for quality of life in people with Parkinson's disease. License as been approved.	Change from Baseline through study completion (at 12 weeks) and at 3 months
Secondary	Falls Efficacy Scale International (FES-I)	A questionnaire related to fear of falling.	Change from Baseline through study completion (at 12 weeks) and at 3 months
Secondary	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.	Change from Baseline through study completion (at 12 weeks) and at 3 months