Efficacy and Safety or Rhythmic Auditory Stimulation (RAS) for Gait and Balance Disorders in Parkinson's Disease

NCT03278639 — Not applicable, Withdrawn, Pontifical Catholic University of Argentina

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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

Registry	NCT03278639, acronym ERA-EP2
Status	Withdrawn - We could not fund the study
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Sponsor	Pontifical Catholic University of Argentina (Other); collaborators: National Council of Scientific and Technical Research, Argentina, Hospital Nacional Profesor Alejandro Posadas, University of Buenos Aires
Conditions	Parkinson Disease
Interventions	Rhythmic Auditory Stimulation, Kinesiology (Behavioral)
Dates	start 2021-03-01 (estimated), primary completion 2023-03-01 (estimated), completion 2023-03-01 (estimated), first posted 2017-09-11, last updated 2021-09-21

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Rhythmic auditory stimulation	Experimental	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 music therapists board-certified in RAS.
Kinesiology	Active comparator	Behavioral: Kinesiology	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.

Rhythmic Auditory Stimulation (Behavioral): Training will be directed to ameliorate gait and balance
Kinesiology (Behavioral): Training will be directed to ameliorate gait and balance

+Outcome measures

Primary outcomes

change from baseline in Tinetti scale total score [4 weeks]

Secondary outcomes

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]
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 MDS-UPDRS score [4 weeks]: MDS-UPDRS is a measure of disease severity
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

Other outcomes

change from baseline in PD CRS [4 weeks and 6 months]: Parkinson's Disease Cognitive Rating Scale (PD CRS) measures cognitive performance
change from baseline in DRS [4 weeks and 6 months]: Dementia Rating Scale (DRS) measures cognitive performance
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]

+Eligibility

Sex: All, ages: 60 Years to 85 Years

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