Clinical trial NCT03278639: Efficacy and Safety or Rhythmic Auditory Stimulation (RAS) for Gait and Balance Disorders in Parkinson's Disease
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Parkinson Disease
Keywords: gait disorders
balance disorders
music
tango
rhythmic auditory stimulation
health-related quality of life
Lead sponsor: Pontifical Catholic University of Argentina
Sponsor class: OTHER
Collaborators: name: National Council of Scientific and Technical Research, Argentina
name: Hospital Nacional Profesor Alejandro Posadas
name: University of Buenos Aires
First posted: 2017-09-11
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, prospective, blind, controlled clinical trial
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Previous use of RAS or kinesiology
* MMSE \>= 24
* BDI \>= 17
* Patients having undergone PD surgical treatments.
* Patients with auditory or visual handicaps

Primary outcomes:
measure: change from baseline in Tinetti scale total score
timeFrame: 4 weeks
Secondary outcomes:
measure: change from baseline in Tinetti scale Gait score
timeFrame: 4 weeks
measure: change from baseline in Tinetti scale Balance score
timeFrame: 4 weeks
measure: change from baseline in Tinetti scale total score
timeFrame: 6 months
measure: change from baseline in Timed Up & Go test (TUG)
timeFrame: 4 weeks
measure: change from baseline in PDQ-39 scores
timeFrame: 4 weeks
measure: change from baseline in MDS-UPDRS score
timeFrame: 4 weeks
measure: change from baseline in Beck Depression Index (BDI)
timeFrame: 4 weeks
measure: change from baseline in MMSE (Mini-Mental State Examination)
timeFrame: 4 weeks
measure: change from baseline in Fall diary
timeFrame: 4 weeks
Other outcomes:
measure: change from baseline in PD CRS
timeFrame: 4 weeks and 6 months
measure: change from baseline in DRS
timeFrame: 4 weeks and 6 months
measure: change from baseline in TUG
timeFrame: 6 months
measure: change from baseline in PDQ-39
timeFrame: 6 months
measure: change from baseline in MDS-UPDRS
timeFrame: 6 months
measure: change from baseline in BDI
timeFrame: 6 months
measure: change from baseline in MMSE
timeFrame: 6 months
measure: change from baseline in fall diary
timeFrame: 6 months
Locations:
Study officials:
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