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

Not Applicable

Completed

• Conditions: Parkinson Disease

• Registration Number: NCT03228888
• Lead Sponsor: University of Cagliari

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-01
• Primary Completion: 2016-12-31
• Status Verified: 2017-07
• Study Completion: 2017-07-01
• Study First Submitted: 2017-07-21
• Study First Submitted QC: 2017-07-21
• Last Update Submitted: 2017-07-21
• Study First Posted: 2017-07-25
• Last Update Posted: 2017-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Walking speed	5 weeks	Walking speed calculated on a 10 m path using motion-capture system

Secondary Outcome Measures

Name	Time	Method
Hip Flexion-extension	5 weeks	Angle of flexion-extension of hip joint during a gait cycle
Knee Flexion-extension	5 weeks	Angle of flexion-extension of knee joint during a gait cycle
GPS	5 weeks	Gait Profile Score (synthetic index of deviation from a physiologic gait pattern)
Ankle Dorsi- Plantar-flexion	5 weeks	Angle of dorsi- plantar-flexion of ankle joint during a gait cycle

Trial Locations

Locations (1)

General Hospital "G. Brotzu"; 🇮🇹 Cagliari, Italy