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Clinical Trials/NCT03316365
NCT03316365
Completed
Not Applicable

Long-term Training Effects of Rhythmic Auditory Stimulation on Gait in Patients With Parkinson's Disease

University of Toronto0 sites60 target enrollmentAugust 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Continuous Rhythmic Auditory Stimulation
Sponsor
University of Toronto
Enrollment
60
Primary Endpoint
Fall Index
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2009
End Date
August 2011
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael H. Thaut

Professor

University of Toronto

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).

Outcomes

Primary Outcomes

Fall Index

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.

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 Outcomes

  • Falls Efficacy Scale (FES)(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.)
  • Berg Balance Scale (BBS)(Change in balance from baseline assessed by Berg Balance Scale at 8 weeks, 16 weeks, and 24 weeks.)
  • Timed Up and Go (TUG)(Change in balance and function from baseline assessed by Timed Up and Go at 8 weeks, 16 weeks, and 24 weeks.)
  • Gait(Change in gait from baseline at 8 weeks, 16 weeks, and 24 weeks.)

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