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Clinical Trials/NCT02999997
NCT02999997
Completed
N/A

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

University Hospital, Linkoeping1 site in 1 country51 target enrollmentJanuary 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
University Hospital, Linkoeping
Enrollment
51
Locations
1
Primary Endpoint
Timed Up and Go Cognitive (TUGcog) (motor-cognitive dual task)
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2017
End Date
May 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Linkoeping
Responsible Party
Principal Investigator
Principal Investigator

Petra Pohl

PhD, Researcher

University Hospital, Linkoeping

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

Outcomes

Primary Outcomes

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.

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

  • Mini-BESTest (Balance Evaluation Systems Test)(Change from Baseline through study completion (at 12 weeks) and at 3 months)
  • Montreal Cognitive Assessment (MoCA)(Change from Baseline through study completion (at 12 weeks) and at 3 months)
  • Symbol Digit Modalities Test (SDMT)(Change from Baseline through study completion (at 12 weeks) and at 3 months)
  • Grooved Pegboard(Change from Baseline through study completion (at 12 weeks) and at 3 months)
  • Rey complex figure(Change from Baseline through study completion (at 12 weeks) and at 3 months)
  • Berg Balance Scale(Change from Baseline through study completion (at 12 weeks) and at 3 months)
  • Chair stand 30 seconds(Change from Baseline through study completion (at 12 weeks) and at 3 months)
  • Auditory memory test, direct and delayed(Change from Baseline through study completion (at 12 weeks) and at 3 months)
  • Trail Making Test A and B(Change from Baseline through study completion (at 12 weeks) and at 3 months)
  • WHODAS 2.0(Baseline)
  • Freezing of gait questionnaire(Change from Baseline through study completion (at 12 weeks) and at 3 months)
  • Falls Efficacy Scale International (FES-I)(Change from Baseline through study completion (at 12 weeks) and at 3 months)
  • Victoria Stroop test(Change from Baseline through study completion (at 12 weeks) and at 3 months)
  • Parkinson's disease questionnaire 39 items (PDQ-39)(Change from Baseline through study completion (at 12 weeks) and at 3 months)
  • Dual-task cost (DTC)(Change from Baseline through study completion (at 12 weeks) and at 3 months)
  • Four Step Square Test, FSST(Change from Baseline through study completion (at 12 weeks) and at 3 months)
  • Actigraphy with GeneActiv Armband(Change from Baseline through study completion (at 12 weeks) and at 3 months)

Study Sites (1)

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