Parkinson Disease
Conditions
Keywords
gait disorders, balance disorders, music, tango, rhythmic auditory stimulation, health-related quality of life
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.
Interventions
BEHAVIORALRhythmic Auditory Stimulation
Training will be directed to ameliorate gait and balance
BEHAVIORALKinesiology
Training will be directed to ameliorate gait and balance
Sponsors
National Council of Scientific and Technical Research, Argentina
Hospital Nacional Profesor Alejandro Posadas
University of Buenos Aires
Pontifical Catholic University of Argentina
Study design
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.
Intervention model description
randomized, prospective, blind, controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change from baseline in Tinetti scale total score | 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline in MDS-UPDRS score | 4 weeks | MDS-UPDRS is a measure of disease severity |
| change from baseline in PDQ-39 scores | 4 weeks | PDQ-39 is a PD-specific scale for Health-related Quality of Life |
| change from baseline in Beck Depression Index (BDI) | 4 weeks | — |
| change from baseline in MMSE (Mini-Mental State Examination) | 4 weeks | MMSE is a measure of cognitive impairment |
| change from baseline in Fall diary | 4 weeks | patients will have to indicate the number of daily falls over a 15-d period |
| 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 | 6 months | training will last for the first 4 weeks. Assessments will be also performed at Month 6 to check lasting effects. |
| change from baseline in Timed Up & Go test (TUG) | 4 weeks | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| change from baseline in DRS | 4 weeks and 6 months | Dementia Rating Scale (DRS) measures cognitive performance |
| change from baseline in PD CRS | 4 weeks and 6 months | Parkinson's Disease Cognitive Rating Scale (PD CRS) measures cognitive performance |
Outcome results
None listed