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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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ClinicalTrials.gov Identifier: NCT03228888
Recruitment Status : Completed
First Posted : July 25, 2017
Last Update Posted : July 25, 2017
Sponsor:
Information provided by (Responsible Party):
Massimiliano Pau, 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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Other: Administration of rhytmic acoustic stimuli for gait training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Ecological Rythmic-acoustic Stimulation (E-RAS) on Motor Skills in Individuals
Actual Study Start Date : November 1, 2014
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : July 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Artificial Sounds

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.

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

Experimental: Ecological Sounds

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.

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




Primary Outcome Measures :
  1. Walking speed [ Time Frame: 5 weeks ]
    Walking speed calculated on a 10 m path using motion-capture system


Secondary Outcome Measures :
  1. Hip Flexion-extension [ Time Frame: 5 weeks ]
    Angle of flexion-extension of hip joint during a gait cycle

  2. Knee Flexion-extension [ Time Frame: 5 weeks ]
    Angle of flexion-extension of knee joint during a gait cycle

  3. Ankle Dorsi- Plantar-flexion [ Time Frame: 5 weeks ]
    Angle of dorsi- plantar-flexion of ankle joint during a gait cycle

  4. GPS [ Time Frame: 5 weeks ]
    Gait Profile Score (synthetic index of deviation from a physiologic gait pattern)



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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228888


Locations
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Italy
General Hospital "G. Brotzu"
Cagliari, Italy, 09100
Sponsors and Collaborators
University of Cagliari

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Massimiliano Pau, Associate Professor, University of Cagliari
ClinicalTrials.gov Identifier: NCT03228888     History of Changes
Other Study ID Numbers: PG/2014/17870
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Massimiliano Pau, University of Cagliari:
Rhythm
Ecological sounds
Auditory stimuli
rhythmic auditory stimulation
Parkinson's Disease
Gait
Gait analysis
Spatio-temporal parameters
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases