Long-term Training Effects of Rhythmic Auditory Stimulation on Gait in Patients With Parkinson's Disease
Primary Purpose
Continuous Rhythmic Auditory Stimulation, Intermittent Rhythmic Auditory Stimulation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rhythmic Auditory Stimulation (RAS)
Sponsored by
About this trial
This is an interventional treatment trial for Continuous Rhythmic Auditory Stimulation
Eligibility Criteria
Inclusion Criteria:
- Hoehn & Yahr (HY) stage III or IV
- At least 2 falls in the past 12 months
- Stable antiparkinsonian medication regime
- Ability to ambulate independently for at least 50 m.
Exclusion Criteria:
- Other neurological or orthopedic conditions
- Medically diagnosed hearing loss
- Dementia (Mini Mental Status Exam score < 24).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Continuous RAS
Intermittent RAS
Arm Description
The experimental group (continuous treatment) trained daily with RAS for 24 weeks.
The control group (intermittent treatment) trained with RAS for 8 weeks, discontinued training for 8 weeks, and resumed training with RAS for 8 weeks.
Outcomes
Primary Outcome Measures
Fall Index
The Fall Index was computed based on self-reports by subjects or caregivers and classified as 1 (incomplete fall, lost balance but stabilized by another person or object), 2 (complete fall, no injuries) or 3 (complete fall, injury, medical attention required). A complete fall was defined as unintentionally coming to the ground with any body part above ankle. Higher Fall Index values indicate higher incidence of falls.
Secondary Outcome Measures
Falls Efficacy Scale (FES)
Falls Efficacy Scale (FES) (Tinetti et al 1990) is a 10-item scale to assess fear of falling in older persons. Individuals are asked to rate, on a 10-point scale with zero corresponding to not at all and 10 to completely, how confident he or she felt in performing 10 activities. The scores are added up to calculate a total score that ranges from 0 to 100. Higher scores indicate more confidence/less fear.
Berg Balance Scale (BBS)
It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function, and the final measure is the sum of all of the scores.
Timed Up and Go (TUG)
Measure of function (rise from a chair, walk three meters, turn around, walk back to the chair, and sit down) with correlates to balance and fall risk. A faster time indicates a better functional performance.
Gait
Assessment of gait parameters (velocity, stride length, cadence, ankle dorsiflexion) with a computerized stride analyzer system (B&L Engineering).
Full Information
NCT ID
NCT03316365
First Posted
October 16, 2017
Last Updated
June 19, 2018
Sponsor
University of Toronto
Collaborators
Poudre Valley Health System Fort Collins CO, Colorado State University
1. Study Identification
Unique Protocol Identification Number
NCT03316365
Brief Title
Long-term Training Effects of Rhythmic Auditory Stimulation on Gait in Patients With Parkinson's Disease
Official Title
Long-term Training Effects of Rhythmic Auditory Stimulation on Gait in Patients With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
August 2009 (Actual)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto
Collaborators
Poudre Valley Health System Fort Collins CO, Colorado State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Falls are common among patients with Parkinson's Disease (PD) and are the biggest contributors to loss of independent living, long-term institutionalization, and increased mortality.
The purpose of this study was to explore whether an at-home based Rhythmic Auditory Stimulation (RAS) gait training program will decrease the number of falls in persons with PD with a history of falling. We also evaluated changes in clinical and kinematic parameters used to assess fall risk in this population.
Sixty participants diagnosed with idiopathic PD with at least 2 falls in the past 12 months, were randomly allocated into two groups. The experimental group trained daily with RAS for 24 weeks. The control group also trained daily with RAS, but discontinued training between weeks 8 and 16. During treatment patients walked for 30 minutes in a home based environment with metronome-click embedded music. Changes in clinical and kinematic parameters were assessed at baseline, weeks 8, 16, and 24.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Continuous Rhythmic Auditory Stimulation, Intermittent Rhythmic Auditory Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Masking Description
Home training instructions were provided by a certified physical therapist and board-certified neurologic music therapist blinded to treatment allocation of the subjects.
The TUG and the BBS were administered by an experienced physical therapist blinded to the study design.
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Continuous RAS
Arm Type
Experimental
Arm Description
The experimental group (continuous treatment) trained daily with RAS for 24 weeks.
Arm Title
Intermittent RAS
Arm Type
Active Comparator
Arm Description
The control group (intermittent treatment) trained with RAS for 8 weeks, discontinued training for 8 weeks, and resumed training with RAS for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Rhythmic Auditory Stimulation (RAS)
Other Intervention Name(s)
Neurologic Music Therapy
Intervention Description
The experimental group (continuous treatment) trained daily with Rhythmic Auditory Stimulation (RAS) for 24 weeks. The control group (intermittent treatment) trained with RAS for 8 weeks, discontinued training for 8 weeks, and resumed training with RAS for 8 weeks. During treatment subjects walked for 30 minutes in a home-based environment with metronome-click embedded music downloaded to an MP3 player and listened to either free-field or via headphones. For the first 8 weeks subjects had 3 metronome rates available to choose from: 100, 105, and 110% of internal usual cadence. During the second 8 weeks available rates were 105, 110 and 115%; and during the last 8 weeks 110, 115, 120%. The control group started their last training segment at 105, 110, and 115%, but could request a change to the faster rates if comfortable.
Primary Outcome Measure Information:
Title
Fall Index
Description
The Fall Index was computed based on self-reports by subjects or caregivers and classified as 1 (incomplete fall, lost balance but stabilized by another person or object), 2 (complete fall, no injuries) or 3 (complete fall, injury, medical attention required). A complete fall was defined as unintentionally coming to the ground with any body part above ankle. Higher Fall Index values indicate higher incidence of falls.
Time Frame
Change of the number of fall incidents and severity from baseline assessed by the Fall Index 8 weeks, 16 weeks, and 24 weeks.
Secondary Outcome Measure Information:
Title
Falls Efficacy Scale (FES)
Description
Falls Efficacy Scale (FES) (Tinetti et al 1990) is a 10-item scale to assess fear of falling in older persons. Individuals are asked to rate, on a 10-point scale with zero corresponding to not at all and 10 to completely, how confident he or she felt in performing 10 activities. The scores are added up to calculate a total score that ranges from 0 to 100. Higher scores indicate more confidence/less fear.
Time Frame
Change in level of concern about falling from baseline assessed by Fear of the Falling Questionnaire/Short FES-1 at 8 weeks, 16 weeks, and 24 weeks.
Title
Berg Balance Scale (BBS)
Description
It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function, and the final measure is the sum of all of the scores.
Time Frame
Change in balance from baseline assessed by Berg Balance Scale at 8 weeks, 16 weeks, and 24 weeks.
Title
Timed Up and Go (TUG)
Description
Measure of function (rise from a chair, walk three meters, turn around, walk back to the chair, and sit down) with correlates to balance and fall risk. A faster time indicates a better functional performance.
Time Frame
Change in balance and function from baseline assessed by Timed Up and Go at 8 weeks, 16 weeks, and 24 weeks.
Title
Gait
Description
Assessment of gait parameters (velocity, stride length, cadence, ankle dorsiflexion) with a computerized stride analyzer system (B&L Engineering).
Time Frame
Change in gait from baseline at 8 weeks, 16 weeks, and 24 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hoehn & Yahr (HY) stage III or IV
At least 2 falls in the past 12 months
Stable antiparkinsonian medication regime
Ability to ambulate independently for at least 50 m.
Exclusion Criteria:
Other neurological or orthopedic conditions
Medically diagnosed hearing loss
Dementia (Mini Mental Status Exam score < 24).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Thaut, PhD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be made available to external researchers.
Learn more about this trial
Long-term Training Effects of Rhythmic Auditory Stimulation on Gait in Patients With Parkinson's Disease
We'll reach out to this number within 24 hrs