Parkinson DiseaseERA-EP2NCT03278639
Efficacy and Safety or Rhythmic Auditory Stimulation (RAS) for Gait and Balance Disorders in Parkinson's Disease
A study testing Rhythmic Auditory Stimulation and Kinesiology in people with Parkinson Disease, run by Pontifical Catholic University of Argentina.
Trial summary
Gait deficits are among the most characteristic and most functionally debilitating signs of the motor neuropathology of Parkinson's disease (PD). Rhythmic Auditory Stimulation (RAS) is a technique by which a series of auditory stimuli are presented at a fixed rhythm, so that patients have to synchronize their… Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Rhythmic Auditory Stimulation and Kinesiology
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2021to Mar 2023
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically definitive or probable PD diagnosis
- Gait disorders (MDS-UPDRS #2.12 =1)
- Patients that can be reasonably expected to remain in ON-state during training sessions.
Who cannot join
- Previous use of RAS or kinesiology
- MMSE >= 24
- BDI >= 17
- Patients having undergone PD surgical treatments.
- Patients with auditory or visual handicaps
About this study
Official title: Randomized, Blind, Controlled Clinical Trial to Assess the Efficacy and Safety or Rhythmic Auditory Stimulation (RAS) for Gait and Balance Disorders in Parkinson's Disease
Gait deficits are among the most characteristic and most functionally debilitating signs of the motor neuropathology of Parkinson's disease (PD). Rhythmic Auditory Stimulation (RAS) is a technique by which a series of auditory stimuli are presented at a fixed rhythm, so that patients have to synchronize their movements to the rhythms. In this study, auditory stimuli will be constituted by Tango musical pieces, which tempo is modified to adapt to patients' walking cadence. Previous results suggested that RAS can increase Tinetti's gait and balance and may also improve Health-Related Quality of Life. This will be a randomized, blind, controlled clinical trial to further assess RAS efficacy and safety.
- Conditions
- Parkinson Disease
- Being tested
- Rhythmic Auditory Stimulation, Kinesiology
- Keywords
- gait disorders, balance disorders, music, tango, rhythmic auditory stimulation, health-related quality of life
- Medical subject headings
- Parkinson Disease, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhythmic Auditory StimulationBehavioural
Training will be directed to ameliorate gait and balance
KinesiologyBehavioural
Training will be directed to ameliorate gait and balance
| Study group | Role | What they receive |
|---|---|---|
| Rhythmic auditory stimulation | Experimental | Each patient will receive training for 4 weeks, 3 times per week. Each training session will last 30 minutes. Training will be performed by music therapists board-certified in RAS. Receives: Behavioral: Rhythmic Auditory Stimulation |
| Kinesiology | Active comparator | Each patient will receive training for 4 weeks, 3 times per week. Each training session will last 30 minutes. Training will be performed by board-certified kinesio therapists. The objectives of the training sessions will match those of RAS. Receives: Behavioral: Kinesiology |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in Tinetti scale total score
Measured: 4 weeks
Secondary outcomes (9)
change from baseline in Tinetti scale Gait score
Measured: 4 weeks
change from baseline in Tinetti scale Balance score
Measured: 4 weeks
change from baseline in Tinetti scale total score
training will last for the first 4 weeks. Assessments will be also performed at Month 6 to check lasting effects.
Measured: 6 months
change from baseline in Timed Up & Go test (TUG)
Measured: 4 weeks
change from baseline in PDQ-39 scores
PDQ-39 is a PD-specific scale for Health-related Quality of Life
Measured: 4 weeks
change from baseline in MDS-UPDRS score
MDS-UPDRS is a measure of disease severity
Measured: 4 weeks
change from baseline in Beck Depression Index (BDI)
Measured: 4 weeks
change from baseline in MMSE (Mini-Mental State Examination)
MMSE is a measure of cognitive impairment
Measured: 4 weeks
change from baseline in Fall diary
patients will have to indicate the number of daily falls over a 15-d period
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study startMar 2021 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Why it stopped: We could not fund the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- randomized, prospective, blind, controlled clinical trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontifical Catholic University of Argentina
- Sponsor type
- University, hospital or other
- Collaborators
- National Council of Scientific and Technical Research, Argentina, Hospital Nacional Profesor Alejandro Posadas, University of Buenos Aires
- Responsible party
- Principal investigator, Santiago Perez Lloret, Pontifical Catholic University of Argentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278639
- Sponsor's protocol ID
- ERAEP2
- Acronym
- ERA-EP2
- Status last verified
- Sep 2021
- First submitted
- 6 Sep 2017
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Blind, Controlled Clinical Trial to Assess the Efficacy and Safety or Rhythmic Auditory Stimulation (RAS) for Gait and Balance Disorders in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03278639
- Acronym / sponsor ID
- ERA-EP2 / ERAEP2
- Conditions
- Parkinson Disease
- Keywords
- gait disorders, balance disorders, music, tango, rhythmic auditory stimulation, health-related quality of life
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We could not fund the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pontifical Catholic University of ArgentinaUniversity, hospital or other
- Collaborators
- National Council of Scientific and Technical Research, Argentina, Hospital Nacional Profesor Alejandro Posadas, University of Buenos Aires
- Study start
- Mar 2021 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 11 Sep 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.
Gait deficits are among the most characteristic and most functionally debilitating signs of the motor neuropathology of Parkinson's disease (PD). Rhythmic Auditory Stimulation (RAS) is a technique by which a series of auditory stimuli are presented at a fixed rhythm, so that patients have to synchronize their movements to the rhythms. In this study, auditory stimuli will be constituted by Tango musical pieces, which tempo is modified to adapt to patients' walking cadence. Previous results suggested that RAS can increase Tinetti's gait and balance and may also improve Health-Related Quality of Life. This will be a randomized, blind, controlled clinical trial to further assess RAS efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, prospective, blind, controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Rhythmic auditory stimulation | Experimental | Behavioral: Rhythmic Auditory StimulationEach patient will receive training for 4 weeks, 3 times per week. Each training session will last 30 minutes. Training will be performed by music therapists board-certified in RAS. |
| Kinesiology | Active comparator | Behavioral: KinesiologyEach patient will receive training for 4 weeks, 3 times per week. Each training session will last 30 minutes. Training will be performed by board-certified kinesio therapists. The objectives of the training sessions will match those of RAS. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinically definitive or probable PD diagnosis
- Gait disorders (MDS-UPDRS #2.12 =1)
- Patients that can be reasonably expected to remain in ON-state during training sessions.
Key exclusion criteria (5 listed)
- Previous use of RAS or kinesiology
- MMSE >= 24
- BDI >= 17
- Patients having undergone PD surgical treatments.
- Patients with auditory or visual handicaps
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 |
|---|---|---|
| Rhythmic Auditory StimulationTraining will be directed to ameliorate gait and balance | Behavioural | Rhythmic auditory stimulation |
| KinesiologyTraining will be directed to ameliorate gait and balance | Behavioural | Kinesiology |
Primary outcome
change from baseline in Tinetti scale total score
Time frame: 4 weeks
9 secondary outcomes
change from baseline in Tinetti scale Gait score
Time frame: 4 weeks
change from baseline in Tinetti scale Balance score
Time frame: 4 weeks
change from baseline in Tinetti scale total score
Time frame: 6 months
change from baseline in Timed Up & Go test (TUG)
Time frame: 4 weeks
change from baseline in PDQ-39 scores
Time frame: 4 weeks
change from baseline in MDS-UPDRS score
Time frame: 4 weeks
change from baseline in Beck Depression Index (BDI)
Time frame: 4 weeks
change from baseline in MMSE (Mini-Mental State Examination)
Time frame: 4 weeks
change from baseline in Fall diary
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Rhythmic Auditory Stimulation and Kinesiology in people with Parkinson Disease, run by Pontifical Catholic University of Argentina.
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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
change from baseline in Tinetti scale total score (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2021.