Clinical trial NCT02999997: Evaluation of Ronnie Gardiner Method in Individuals With Parkinson's Disease
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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Physical therapy modalities
Dual-task performance
Parkinson's disease
Active music therapy
Physical activity
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2016-12-21
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Timed Up and Go Cognitive (TUGcog) (motor-cognitive dual task)
timeFrame: Change from Baseline through study completion (at 12 weeks) and at 3 months
measure: Timed Up and Go manual (TUG manual) (motor-motor dual task)
timeFrame: Change from Baseline through study completion (at 12 weeks) and at 3 months
Secondary outcomes:
measure: Dual-task cost (DTC)
timeFrame: Change from Baseline through study completion (at 12 weeks) and at 3 months
measure: Mini-BESTest (Balance Evaluation Systems Test)
timeFrame: Change from Baseline through study completion (at 12 weeks) and at 3 months
measure: Four Step Square Test, FSST
timeFrame: Change from Baseline through study completion (at 12 weeks) and at 3 months
measure: Berg Balance Scale
timeFrame: Change from Baseline through study completion (at 12 weeks) and at 3 months
measure: Chair stand 30 seconds
timeFrame: Change from Baseline through study completion (at 12 weeks) and at 3 months
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Change from Baseline through study completion (at 12 weeks) and at 3 months
measure: Auditory memory test, direct and delayed
timeFrame: Change from Baseline through study completion (at 12 weeks) and at 3 months
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: Change from Baseline through study completion (at 12 weeks) and at 3 months
measure: Victoria Stroop test
timeFrame: Change from Baseline through study completion (at 12 weeks) and at 3 months
measure: Grooved Pegboard
timeFrame: Change from Baseline through study completion (at 12 weeks) and at 3 months
measure: Trail Making Test A and B
timeFrame: Change from Baseline through study completion (at 12 weeks) and at 3 months
measure: Rey complex figure
timeFrame: Change from Baseline through study completion (at 12 weeks) and at 3 months
measure: WHODAS 2.0
timeFrame: Baseline
measure: Freezing of gait questionnaire
timeFrame: Change from Baseline through study completion (at 12 weeks) and at 3 months
measure: Parkinson's disease questionnaire 39 items (PDQ-39)
timeFrame: Change from Baseline through study completion (at 12 weeks) and at 3 months
measure: Falls Efficacy Scale International (FES-I)
timeFrame: Change from Baseline through study completion (at 12 weeks) and at 3 months
measure: Actigraphy with GeneActiv Armband
timeFrame: Change from Baseline through study completion (at 12 weeks) and at 3 months
Other outcomes:
Locations:
city: Linkoping
country: Sweden
facility: Neurological clinic, Linkoeping Universityhospital
state: Ostergotland
Study officials:
affiliation: University Hospital, Linkoeping
name: Petra Pohl, PhD, RPT
role: PRINCIPAL_INVESTIGATOR
References: