Clinical trial NCT03228888: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Rhythm
Ecological sounds
Auditory stimuli
rhythmic auditory stimulation
Parkinson's Disease
Gait
Gait analysis
Spatio-temporal parameters
Lead sponsor: University of Cagliari
Sponsor class: OTHER
First posted: 2017-07-25
Enrollment: 32
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.


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:

-

Primary outcomes:
measure: Walking speed
timeFrame: 5 weeks
Secondary outcomes:
measure: Hip Flexion-extension
timeFrame: 5 weeks
measure: Knee Flexion-extension
timeFrame: 5 weeks
measure: Ankle Dorsi- Plantar-flexion
timeFrame: 5 weeks
measure: GPS
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Cagliari
country: Italy
facility: General Hospital "G. Brotzu"
Study officials:
References:
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.