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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of RAC With Locomotion Training on Cortical Excitability and Behavior in Patients With PD

NCT03656796

Parkinson's Disease

COMPLETED NA

Effects of Rhythmic Auditory Cueing on Stepping in Place in Patients With Parkinson's Disease

NCT03271736

Parkinson Disease

COMPLETED NA

The Effects of Auditory Cues on Gait Mechanics in Parkinson's Disease

NCT03253965

Parkinson Disease

COMPLETED NA

Efficacy and Safety or Rhythmic Auditory Stimulation (RAS) for Gait and Balance Disorders in Parkinson's Disease

NCT03278639

Parkinson Disease

WITHDRAWN NA

Effect of Haptic Cueing on Long-Range Autocorrelations in Parkinson's Disease Gait Variability

NCT05790759

Parkinson Disease Gait, Unsteady

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Continuous Rhythmic Auditory Stimulation Intermittent Rhythmic Auditory Stimulation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Continuous RAS

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

Group Type EXPERIMENTAL

Rhythmic Auditory Stimulation (RAS)

Intervention Type 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.

Intermittent RAS

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

Group Type ACTIVE_COMPARATOR

Rhythmic Auditory Stimulation (RAS)

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rhythmic Auditory Stimulation (RAS)

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Neurologic Music Therapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.