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Evaluation of Ronnie Gardiner Method in Individuals With Parkinson's Disease (RGM/PD)

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Ronnie Gardiner Method (RGM)
Sponsored by
University Hospital, Linkoeping
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Physical therapy modalities, Dual-task performance, Parkinson's disease, Active music therapy, Physical activity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Neurological clinic, Linkoeping Universityhospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Ronnie Gardiner Method (RGM)

Control group

Arm Description

Exercising two times/week according to the RGM program in groups of 15 participants (2 groups).

Participants in the control group are instructed to live their ordinary life.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
December 10, 2016
Last Updated
May 1, 2018
Sponsor
University Hospital, Linkoeping
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1. Study Identification

Unique Protocol Identification Number
NCT02999997
Brief Title
Evaluation of Ronnie Gardiner Method in Individuals With Parkinson's Disease
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Linkoeping

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Physical therapy modalities, Dual-task performance, Parkinson's disease, Active music therapy, Physical activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ronnie Gardiner Method (RGM)
Arm Type
Experimental
Arm Description
Exercising two times/week according to the RGM program in groups of 15 participants (2 groups).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants in the control group are instructed to live their ordinary life.
Intervention Type
Behavioral
Intervention Name(s)
Ronnie Gardiner Method (RGM)
Other Intervention Name(s)
In Sweden and Israel known as RGRM
Intervention Description
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.
Primary Outcome Measure Information:
Title
Timed Up and Go Cognitive (TUGcog) (motor-cognitive dual task)
Description
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.
Time Frame
Change from Baseline through study completion (at 12 weeks) and at 3 months
Title
Timed Up and Go manual (TUG manual) (motor-motor dual task)
Description
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.
Time Frame
Change from Baseline through study completion (at 12 weeks) and at 3 months
Secondary Outcome Measure Information:
Title
Dual-task cost (DTC)
Description
Measuring the difference between Timed Up and Go (TUG) single task and TUG cognitive and manual respectively
Time Frame
Change from Baseline through study completion (at 12 weeks) and at 3 months
Title
Mini-BESTest (Balance Evaluation Systems Test)
Description
A balance test focusing on dynamic balance and can be conducted in 10-15 minutes.
Time Frame
Change from Baseline through study completion (at 12 weeks) and at 3 months
Title
Four Step Square Test, FSST
Description
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.
Time Frame
Change from Baseline through study completion (at 12 weeks) and at 3 months
Title
Berg Balance Scale
Description
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
Time Frame
Change from Baseline through study completion (at 12 weeks) and at 3 months
Title
Chair stand 30 seconds
Description
Standing up and sitting down, hands crossed over chest, as many times as possible for 30 seconds.
Time Frame
Change from Baseline through study completion (at 12 weeks) and at 3 months
Title
Montreal Cognitive Assessment (MoCA)
Description
Screening of cognitive function. License has been approved.
Time Frame
Change from Baseline through study completion (at 12 weeks) and at 3 months
Title
Auditory memory test, direct and delayed
Description
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.
Time Frame
Change from Baseline through study completion (at 12 weeks) and at 3 months
Title
Symbol Digit Modalities Test (SDMT)
Description
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.
Time Frame
Change from Baseline through study completion (at 12 weeks) and at 3 months
Title
Victoria Stroop test
Description
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".
Time Frame
Change from Baseline through study completion (at 12 weeks) and at 3 months
Title
Grooved Pegboard
Description
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.
Time Frame
Change from Baseline through study completion (at 12 weeks) and at 3 months
Title
Trail Making Test A and B
Description
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.
Time Frame
Change from Baseline through study completion (at 12 weeks) and at 3 months
Title
Rey complex figure
Description
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.
Time Frame
Change from Baseline through study completion (at 12 weeks) and at 3 months
Title
WHODAS 2.0
Description
A questionnaire based on the International Classification of Functioning (ICF) for assessing impairments and function.
Time Frame
Baseline
Title
Freezing of gait questionnaire
Description
A questionnaire with questions about freezing of gait
Time Frame
Change from Baseline through study completion (at 12 weeks) and at 3 months
Title
Parkinson's disease questionnaire 39 items (PDQ-39)
Description
A questionnaire for quality of life in people with Parkinson's disease. License as been approved.
Time Frame
Change from Baseline through study completion (at 12 weeks) and at 3 months
Title
Falls Efficacy Scale International (FES-I)
Description
A questionnaire related to fear of falling.
Time Frame
Change from Baseline through study completion (at 12 weeks) and at 3 months
Title
Actigraphy with GeneActiv Armband
Description
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.
Time Frame
Change from Baseline through study completion (at 12 weeks) and at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petra Pohl, PhD, RPT
Organizational Affiliation
University Hospital, Linkoeping
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neurological clinic, Linkoeping Universityhospital
City
Linkoping
State/Province
Ostergotland
ZIP/Postal Code
58185
Country
Sweden

12. IPD Sharing Statement

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

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