NCT03228888

Effects of Ecological Rythmic-acoustic Stimulation (E-RAS) on Motor Skills in Individuals With Parkinson's Disease

Completed NA Last updated 25 July 2017

What this trial tests

NA trial testing Administration of rhytmic acoustic stimuli for gait training in Parkinson Disease in 32 participants. Completed in 1 July 2017.

Timeline

1 November 2014

Primary endpoint
31 December 2016

1 July 2017

Quick facts

Lead sponsor	University of Cagliari
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	32
Start date	1 November 2014
Primary completion	31 December 2016
Estimated completion	1 July 2017
Sites	1 location across Italy

Drugs / interventions tested

• Administration of rhytmic acoustic stimuli for gait training

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →

Sponsor

University of Cagliari

Who can join

Adults 50 to 90, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The use of rhythmic auditory stimulation (RAS) has been proven useful in the management of gait disturbances induced by Parkinson's disease (PD). Typically, the stimuli used to provide RAS consist of metronome or music-based sounds, which are not related with the auditory experience of walking. Based on previous laboratory research, it is hypothesized that the use of ecological sounds deriving from biological motion (i.e., footstep sounds) could have a greater impact compared to artificial sounds (i.e., metronome sounds), within a rehabilitation program. In a double-blind experiment, it was investigated the effects of 5 weeks of supervised rehabilitation integrated with RAS. Thirty-two individuals affected by PD (age 68.2 ± 10.5, Hoehn and Yahr 1,5-3) were randomly assigned to one of the two conditions (artificial vs. ecological sounds). Spatio-temporal parameters of gait and clinical variables were assessed before the rehabilitation period, at its end, and after a 3-month follow-up. The results revealed that the rehabilitation program integrated with RAS had positive effects on the majority of objective and subjective measures, independently of the type of sound. However, when the two groups were examined separately, the patients assigned to the ecological RAS condition were the only who improved both in terms of cadence and gait speed. Overall, the hypothesized greater effect of the ecological sounds compared to artificial sounds was only partially supported by data.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Use of Footstep Sounds as Rhythmic Auditory Stimulation for Gait Rehabilitation in Parkinson's Disease: A Randomized Controlled Trial.
   Murgia M, Pili R, Corona F, Sors F, et al · · 2018 · cited 48× · PMID 29910764 · DOI 10.3389/fneur.2018.00348