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Clinical Trials/NCT03228888
NCT03228888
Completed
Not Applicable

Effects of Ecological Rythmic-acoustic Stimulation (E-RAS) on Motor Skills in Individuals

University of Cagliari1 site in 1 country32 target enrollmentNovember 1, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
University of Cagliari
Enrollment
32
Locations
1
Primary Endpoint
Walking speed
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2014
End Date
July 1, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Massimiliano Pau

Associate Professor

University of Cagliari

Eligibility Criteria

Inclusion Criteria

  • diagnosis of PD according to the UK Brain Bank criteria;
  • ability to walk independently;
  • absence of relevant hearing impairments which could prevent the correct perception of the auditory cues;
  • absence of significant cognitive impairment (i.e., Mini-Mental Status Examination (MMSE) \> 24; Frontal Assessment Battery (FAB) \> 13);
  • absence of psychiatric or severe systemic illnesses;
  • mild-to-moderate disability assessed by means of the modified Hoehn and Yahr (H\&Y) staging scale (1,5 ≤ H\&Y ≤ 3);
  • no engagement in any rehabilitative program in the 3 months before the beginning of the study

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Walking speed

Time Frame: 5 weeks

Walking speed calculated on a 10 m path using motion-capture system

Secondary Outcomes

  • Hip Flexion-extension(5 weeks)
  • Knee Flexion-extension(5 weeks)
  • GPS(5 weeks)
  • Ankle Dorsi- Plantar-flexion(5 weeks)

Study Sites (1)

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