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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Administration of rhytmic acoustic stimuli for gait training
Sponsored by
University of Cagliari
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Rhythm, Ecological sounds, Auditory stimuli, rhythmic auditory stimulation, Parkinson's Disease, Gait, Gait analysis, Spatio-temporal parameters

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

-

Sites / Locations

  • General Hospital "G. Brotzu"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Artificial Sounds

Ecological Sounds

Arm Description

Participants were provided headphones and a portable MP3 device which played a metronome tick at specified rhythm calculated as follows: a) if a patient's cadence was below the normality, the BPM of the stimulus was set at a value of 10% higher than one's own cadence; b) if a patient's cadence was below, but close to normality (less than 10% difference), the BPM of the stimulus was set at normality values; c) if a patient's cadence was above the normality, the BPM of the stimulus was set at a value equal to one's own cadence. Participants performed daily 30 minutes of walking assisted by the rhythmic acoustic stimuli.

Participants were provided headphones and a portable MP3 device which played an ecological rhythmic sound obtained by actual footsteps of human at specified rhythm calculated as follows: a) if a patient's cadence was below the normality, the BPM of the stimulus was set at a value of 10% higher than one's own cadence; b) if a patient's cadence was below, but close to normality (less than 10% difference), the BPM of the stimulus was set at normality values; c) if a patient's cadence was above the normality, the BPM of the stimulus was set at a value equal to one's own cadence. Participants performed daily 30 minutes of walking assisted by the rhythmic acoustic stimuli.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 21, 2017
Last Updated
July 21, 2017
Sponsor
University of Cagliari
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1. Study Identification

Unique Protocol Identification Number
NCT03228888
Brief Title
Effects of Ecological Rythmic-acoustic Stimulation (E-RAS) on Motor Skills in Individuals With Parkinson's Disease
Official Title
Effects of Ecological Rythmic-acoustic Stimulation (E-RAS) on Motor Skills in Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
November 1, 2014 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
July 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cagliari

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Rhythm, Ecological sounds, Auditory stimuli, rhythmic auditory stimulation, Parkinson's Disease, Gait, Gait analysis, Spatio-temporal parameters

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants were randomly assigned to one of the two groups (artificial or ecological RAS) and were evaluated in three moments: before the rehabilitative treatment (T0), at the end of the 5 week rehabilitative treatment (T5), and 3 months after the end of the treatment, namely 17 weeks after the first assessment (T17).
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Artificial Sounds
Arm Type
Experimental
Arm Description
Participants were provided headphones and a portable MP3 device which played a metronome tick at specified rhythm calculated as follows: a) if a patient's cadence was below the normality, the BPM of the stimulus was set at a value of 10% higher than one's own cadence; b) if a patient's cadence was below, but close to normality (less than 10% difference), the BPM of the stimulus was set at normality values; c) if a patient's cadence was above the normality, the BPM of the stimulus was set at a value equal to one's own cadence. Participants performed daily 30 minutes of walking assisted by the rhythmic acoustic stimuli.
Arm Title
Ecological Sounds
Arm Type
Experimental
Arm Description
Participants were provided headphones and a portable MP3 device which played an ecological rhythmic sound obtained by actual footsteps of human at specified rhythm calculated as follows: a) if a patient's cadence was below the normality, the BPM of the stimulus was set at a value of 10% higher than one's own cadence; b) if a patient's cadence was below, but close to normality (less than 10% difference), the BPM of the stimulus was set at normality values; c) if a patient's cadence was above the normality, the BPM of the stimulus was set at a value equal to one's own cadence. Participants performed daily 30 minutes of walking assisted by the rhythmic acoustic stimuli.
Intervention Type
Other
Intervention Name(s)
Administration of rhytmic acoustic stimuli for gait training
Intervention Description
The intervention consist in 5 weeks, 20 min/day gait training assisted by rhythmic acoustic stimuli administered using a portable MP3 player
Primary Outcome Measure Information:
Title
Walking speed
Description
Walking speed calculated on a 10 m path using motion-capture system
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Hip Flexion-extension
Description
Angle of flexion-extension of hip joint during a gait cycle
Time Frame
5 weeks
Title
Knee Flexion-extension
Description
Angle of flexion-extension of knee joint during a gait cycle
Time Frame
5 weeks
Title
Ankle Dorsi- Plantar-flexion
Description
Angle of dorsi- plantar-flexion of ankle joint during a gait cycle
Time Frame
5 weeks
Title
GPS
Description
Gait Profile Score (synthetic index of deviation from a physiologic gait pattern)
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: -
Facility Information:
Facility Name
General Hospital "G. Brotzu"
City
Cagliari
ZIP/Postal Code
09100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29910764
Citation
Murgia M, Pili R, Corona F, Sors F, Agostini TA, Bernardis P, Casula C, Cossu G, Guicciardi M, Pau M. The Use of Footstep Sounds as Rhythmic Auditory Stimulation for Gait Rehabilitation in Parkinson's Disease: A Randomized Controlled Trial. Front Neurol. 2018 May 24;9:348. doi: 10.3389/fneur.2018.00348. eCollection 2018.
Results Reference
derived

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

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