An interventional study of Rhythmic Auditory Stimulation and Kinesiology in Parkinson Disease, sponsored by Pontifical Catholic University of Argentina. Withdrawn. Open to participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-09-21.
Sponsored by Pontifical Catholic University of Argentina · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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.
Behavioral: Rhythmic Auditory Stimulation
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.
Behavioral: Kinesiology
Training will be directed to ameliorate gait and balance
Training will be directed to ameliorate gait and balance
change from baseline in Tinetti scale total score
Time frame: 4 weeks
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
training will last for the first 4 weeks. Assessments will be also performed at Month 6 to check lasting effects.
Time frame: 6 months
change from baseline in Timed Up & Go test (TUG)
Time frame: 4 weeks
change from baseline in PDQ-39 scores
PDQ-39 is a PD-specific scale for Health-related Quality of Life
Time frame: 4 weeks
change from baseline in MDS-UPDRS score
MDS-UPDRS is a measure of disease severity
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)
MMSE is a measure of cognitive impairment
Time frame: 4 weeks
change from baseline in Fall diary
patients will have to indicate the number of daily falls over a 15-d period
Time frame: 4 weeks
change from baseline in PD CRS
Parkinson's Disease Cognitive Rating Scale (PD CRS) measures cognitive performance
Time frame: 4 weeks and 6 months
change from baseline in DRS
Dementia Rating Scale (DRS) measures cognitive performance
Time frame: 4 weeks and 6 months
change from baseline in TUG
Time frame: 6 months
change from baseline in PDQ-39
Time frame: 6 months
change from baseline in MDS-UPDRS
Time frame: 6 months
change from baseline in BDI
Time frame: 6 months
change from baseline in MMSE
Time frame: 6 months
change from baseline in fall diary
Time frame: 6 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Pontifical Catholic University of Argentina