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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Primary Endpoint
- change from baseline in Tinetti scale total score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
Both investigators taking care of patients and outcomes assessors will be blinded.
Eligibility Criteria
- Ages
- 60 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
change from baseline in Tinetti scale total score
Time Frame: 4 weeks
Secondary Outcomes
- change from baseline in PDQ-39 scores(4 weeks)
- change from baseline in Beck Depression Index (BDI)(4 weeks)
- change from baseline in Tinetti scale total score(6 months)
- change from baseline in MMSE (Mini-Mental State Examination)(4 weeks)
- change from baseline in Fall diary(4 weeks)
- change from baseline in Tinetti scale Gait score(4 weeks)
- change from baseline in Tinetti scale Balance score(4 weeks)
- change from baseline in Timed Up & Go test (TUG)(4 weeks)
- change from baseline in MDS-UPDRS score(4 weeks)
Investigators
Santiago Perez Lloret
MD PhD CPI
Pontifical Catholic University of Argentina