Parkinson DiseaseNCT03228888
Effects of Ecological Rythmic-acoustic Stimulation (E-RAS) on Motor Skills in Individuals With Parkinson's Disease
A study testing Administration of rhytmic acoustic stimuli for gait training in people with Parkinson Disease, run by University of Cagliari at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Administration of rhytmic acoustic stimuli for gait training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2014to 1 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Ecological Rythmic-acoustic Stimulation (E-RAS) on Motor Skills in Individuals
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.
- Conditions
- Parkinson Disease
- Being tested
- Administration of rhytmic acoustic stimuli for gait training
- Keywords
- Rhythm, Ecological sounds, Auditory stimuli, rhythmic auditory stimulation, Parkinson's Disease, Gait, Gait analysis, Spatio-temporal parameters
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of rhytmic acoustic stimuli for gait trainingOther
The intervention consist in 5 weeks, 20 min/day gait training assisted by rhythmic acoustic stimuli administered using a portable MP3 player
| Study group | Role | What they receive |
|---|---|---|
| Artificial Sounds | Experimental | 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. Receives: Other: Administration of rhytmic acoustic stimuli for gait training |
| Ecological Sounds | Experimental | 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. Receives: Other: Administration of rhytmic acoustic stimuli for gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking speed
Walking speed calculated on a 10 m path using motion-capture system
Measured: 5 weeks
Secondary outcomes (4)
Hip Flexion-extension
Angle of flexion-extension of hip joint during a gait cycle
Measured: 5 weeks
Knee Flexion-extension
Angle of flexion-extension of knee joint during a gait cycle
Measured: 5 weeks
Ankle Dorsi- Plantar-flexion
Angle of dorsi- plantar-flexion of ankle joint during a gait cycle
Measured: 5 weeks
GPS
Gait Profile Score (synthetic index of deviation from a physiologic gait pattern)
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start1 Nov 2014
- Primary completion31 Dec 2016
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimiliano Pau, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228888
- Sponsor's protocol ID
- PG/2014/17870
- Status last verified
- Jul 2017
- First submitted
- 21 Jul 2017
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29910764
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ecological Rythmic-acoustic Stimulation (E-RAS) on Motor Skills in Individuals
- ClinicalTrials.gov ID
- NCT03228888
- Acronym / sponsor ID
- PG/2014/17870
- Conditions
- Parkinson Disease
- Keywords
- Rhythm, Ecological sounds, Auditory stimuli, rhythmic auditory stimulation, Parkinson's Disease, Gait, Gait analysis, Spatio-temporal parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 25 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Artificial Sounds | Experimental | Other: Administration of rhytmic acoustic stimuli for gait trainingParticipants 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. |
| Ecological Sounds | Experimental | Other: Administration of rhytmic acoustic stimuli for gait trainingParticipants 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. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of rhytmic acoustic stimuli for gait trainingThe intervention consist in 5 weeks, 20 min/day gait training assisted by rhythmic acoustic stimuli administered using a portable MP3 player | Other | Artificial Sounds, Ecological Sounds |
Primary outcome
Walking speed
Time frame: 5 weeks
Walking speed calculated on a 10 m path using motion-capture system
4 secondary outcomes
Hip Flexion-extension
Time frame: 5 weeks
Knee Flexion-extension
Time frame: 5 weeks
Ankle Dorsi- Plantar-flexion
Time frame: 5 weeks
GPS
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
- Derived from this study: PubMed 29910764Murgia 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Administration of rhytmic acoustic stimuli for gait training in people with Parkinson Disease, run by University of Cagliari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking speed (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03228888, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2017.