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

Parkinson Disease Clinical Trial

— ERA-EP2  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03278639
• Other study ID #: ERAEP2
• Status: Withdrawn
• Phase: N/A
• Start date: March 2021
• Est. completion date: March 2023

Study information

• Verified date: September 2021
• Source: Pontifical Catholic University of Argentina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Pontifical Catholic University of Argentina	Hospital Nacional Profesor Alejandro Posadas, National Council of Scientific and Technical Research, Argentina, University of Buenos Aires

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change from baseline in PD CRS	Parkinson's Disease Cognitive Rating Scale (PD CRS) measures cognitive performance	4 weeks and 6 months
Other	change from baseline in DRS	Dementia Rating Scale (DRS) measures cognitive performance	4 weeks and 6 months
Other	change from baseline in TUG		6 months
Other	change from baseline in PDQ-39		6 months
Other	change from baseline in MDS-UPDRS		6 months
Other	change from baseline in BDI		6 months
Other	change from baseline in MMSE		6 months
Other	change from baseline in fall diary		6 months
Primary	change from baseline in Tinetti scale total score		4 weeks
Secondary	change from baseline in Tinetti scale Gait score		4 weeks
Secondary	change from baseline in Tinetti scale Balance score		4 weeks
Secondary	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.	6 months
Secondary	change from baseline in Timed Up & Go test (TUG)		4 weeks
Secondary	change from baseline in PDQ-39 scores	PDQ-39 is a PD-specific scale for Health-related Quality of Life	4 weeks
Secondary	change from baseline in MDS-UPDRS score	MDS-UPDRS is a measure of disease severity	4 weeks
Secondary	change from baseline in Beck Depression Index (BDI)		4 weeks
Secondary	change from baseline in MMSE (Mini-Mental State Examination)	MMSE is a measure of cognitive impairment	4 weeks
Secondary	change from baseline in Fall diary	patients will have to indicate the number of daily falls over a 15-d period	4 weeks