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Completed

NCT Number: NCT03228888

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

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.

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Key information

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital "G. Brotzu"

Cagliari, 09100, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Administration of rhytmic acoustic stimuli for gait training

Other

The intervention consist in 5 weeks, 20 min/day gait training assisted by rhythmic acoustic stimuli administered using a portable MP3 player

Primary outcomes

  1. Walking speed

    Time frame: 5 weeks

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

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Cagliari

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jul 25, 2017
Registry last updated
Jul 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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