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

NCT03316365 | Completed

• 1 other identifier: 06-785
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Continuous Rhythmic Auditory Stimulation; Intermittent Rhythmic Auditory Stimulation

Outcome Measures

Primary Outcomes (1)

• 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.

  Change of the number of fall incidents and severity from baseline assessed by the Fall Index 8 weeks, 16 weeks, and 24 weeks.

Secondary Outcomes (4)

• 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.

Study Arms (2)

Continuous RAS

EXPERIMENTAL

The experimental group (continuous treatment) trained daily with RAS for 24 weeks.

Other: Rhythmic Auditory Stimulation (RAS)

Intermittent RAS

ACTIVE COMPARATOR

The control group (intermittent treatment) trained with RAS for 8 weeks, discontinued training for 8 weeks, and resumed training with RAS for 8 weeks.

Other: Rhythmic Auditory Stimulation (RAS)

Interventions

Rhythmic Auditory Stimulation (RAS) OTHER

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.

Also known as: Neurologic Music Therapy

Continuous RAS; Intermittent RAS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Other neurological or orthopedic conditions
• Medically diagnosed hearing loss
• Dementia (Mini Mental Status Exam score \< 24).

Sponsors & Collaborators

• University of Toronto: lead
• Poudre Valley Health System Fort Collins CO: collaborator
• Colorado State University: collaborator

Study Officials

• Michael Thaut, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: October 20, 2017
• Study Start: August 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: June 21, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share