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| Name | Class |
|---|---|
| National Council of Scientific and Technical Research, Argentina | OTHER_GOV |
| Hospital Nacional Profesor Alejandro Posadas | OTHER |
| University of Buenos Aires | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rhythmic Auditory Stimulation | Behavioral | Training will be directed to ameliorate gait and balance |
|
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in Tinetti scale total score | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in Tinetti scale Gait score | 4 weeks | |
| change from baseline in Tinetti scale Balance score | 4 weeks | |
| change from baseline in Tinetti scale total score |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in PD CRS | Parkinson's Disease Cognitive Rating Scale (PD CRS) measures cognitive performance | 4 weeks and 6 months |
| change from baseline in DRS | Dementia Rating Scale (DRS) measures cognitive performance |
Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D051346 | Mobility Limitation |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D018953 | Kinesiology, Applied |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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randomized, prospective, blind, controlled clinical trial
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Both investigators taking care of patients and outcomes assessors will be blinded.
| Kinesiology | Behavioral | Training will be directed to ameliorate gait and balance |
|
training will last for the first 4 weeks. Assessments will be also performed at Month 6 to check lasting effects. |
| 6 months |
| change from baseline in Timed Up & Go test (TUG) | 4 weeks |
| change from baseline in PDQ-39 scores | PDQ-39 is a PD-specific scale for Health-related Quality of Life | 4 weeks |
| change from baseline in MDS-UPDRS score | MDS-UPDRS is a measure of disease severity | 4 weeks |
| change from baseline in Beck Depression Index (BDI) | 4 weeks |
| change from baseline in MMSE (Mini-Mental State Examination) | MMSE is a measure of cognitive impairment | 4 weeks |
| change from baseline in Fall diary | patients will have to indicate the number of daily falls over a 15-d period | 4 weeks |
| 4 weeks and 6 months |
| change from baseline in TUG | 6 months |
| change from baseline in PDQ-39 | 6 months |
| change from baseline in MDS-UPDRS | 6 months |
| change from baseline in BDI | 6 months |
| change from baseline in MMSE | 6 months |
| change from baseline in fall diary | 6 months |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012046 | Rehabilitation |