CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 31 enrolled
Drug / intervention
Subject-specific optimized RAS +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05733819
NCT05733819Phase 1Completed

Responders to Metronome-based Rhythmic Auditory Cueing in Parkinson Disease

Boston University Charles River Campus·interventional·Posted Feb 17, 2023·Updated Mar 18, 2024

In Brief

A Phase 1 clinical trial evaluating Subject-specific optimized RAS and Active Walking for Parkinson Disease. Completed, enrolled 31 participants across 1 site.

Detailed Summary

Parkinson disease (PD) is the second most common neurodegenerative disease affecting approximately 10 million people worldwide. It is a complex movement disorder that results in reduced walking ability. Prior studies have identified declines in walking as a marker of ensuing disability. Rhythmic auditory stimulation (RAS) is a rehabilitation approach that employs the coupling of auditory cues with movement. Walking with RAS has been shown to benefit walking rhythmicity, quality, and speed. These walking benefits make RAS advantageous in promoting regular moderate-intensity walking activity -- an important health objective in the management of PD. However, there is limited research investigating the effects of RAS on walking quality and how improvements in walking speed are achieved. This study will enroll 30 individuals with mild to moderate PD where each participant will be asked to complete two six-minute walk tests, one standard test (baseline) and the other using an optimized metronome-based auditory cueing RAS intervention. The investigators hypothesize that individuals with PD will either walk farther or with more automaticity (i.e., reduced stride time variability) in the RAS condition compared to the baseline condition. Moreover, these walking improvements will be accompanied by improvements in gait mechanics and metabolic cost of walking.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedFeb 17, 2023
Enrollment StartJan 17, 2023
Primary CompletionJun 20, 2023
Study CompletionJun 30, 2023
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 3.4 years ago

Interventions

Subject-specific optimized RASdevice

Walking with metronome-based RAS cueing

Active Walkingbehavioral

Walking without RAS cueing