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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03228888
• Other study ID #: PG/2014/17870
• Status: Completed
• Phase: N/A
• First received: July 21, 2017
• Last updated: July 21, 2017
• Start date: November 1, 2014
• Est. completion date: July 1, 2017

Study information

• Verified date: July 2017
• Source: University of Cagliari
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 1, 2017
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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:

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Administration of rhytmic acoustic stimuli for gait training
The intervention consist in 5 weeks, 20 min/day gait training assisted by rhythmic acoustic stimuli administered using a portable MP3 player

Locations

Country	Name	City	State
Italy	General Hospital "G. Brotzu"	Cagliari

Sponsors (1)

Lead Sponsor	Collaborator
University of Cagliari

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Walking speed	Walking speed calculated on a 10 m path using motion-capture system	5 weeks
Secondary	Hip Flexion-extension	Angle of flexion-extension of hip joint during a gait cycle	5 weeks
Secondary	Knee Flexion-extension	Angle of flexion-extension of knee joint during a gait cycle	5 weeks
Secondary	Ankle Dorsi- Plantar-flexion	Angle of dorsi- plantar-flexion of ankle joint during a gait cycle	5 weeks
Secondary	GPS	Gait Profile Score (synthetic index of deviation from a physiologic gait pattern)	5 weeks