NCT02999997

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. 1.dual task performance (motor-motor, and motor-cognitive)
  2. 2.level of physical activity, motor function and balance
  3. 3.cognitive function including memory and spatial function
  4. 4.health-related quality of life, fear of falling, and freezing of gait
  5. 5.qualitative interviews from focus group discussions

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 21, 2016

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

May 2, 2018

Status Verified

May 1, 2018

Enrollment Period

1.2 years

First QC Date

December 10, 2016

Last Update Submit

May 1, 2018

Conditions

Keywords

Physical therapy modalitiesDual-task performanceParkinson's diseaseActive music therapyPhysical activity

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (17)

  • Dual-task cost (DTC)

    Change from Baseline through study completion (at 12 weeks) and at 3 months

  • Mini-BESTest (Balance Evaluation Systems Test)

    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

  • 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

  • +12 more secondary outcomes

Study Arms (2)

Ronnie Gardiner Method (RGM)

EXPERIMENTAL

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

Behavioral: Ronnie Gardiner Method (RGM)

Control group

NO INTERVENTION

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

Interventions

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.

Also known as: In Sweden and Israel known as RGRM
Ronnie Gardiner Method (RGM)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • parkinsonism of other origin, color blindness, severely impaired vision or hearing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurological clinic, Linkoeping Universityhospital

Linköping, Östergötland County, 58185, Sweden

Location

Related Publications (2)

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

MeSH Terms

Conditions

Parkinson DiseaseMotor Activity

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehavior

Study Officials

  • Petra Pohl, PhD, RPT

    University Hospital, Linkoeping

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Researcher

Study Record Dates

First Submitted

December 10, 2016

First Posted

December 21, 2016

Study Start

January 1, 2017

Primary Completion

April 1, 2018

Study Completion

May 1, 2018

Last Updated

May 2, 2018

Record last verified: 2018-05

Locations