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

NCT03278639 | Withdrawn

• 1 other identifier: ERAEP2
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson Disease

Keywords

gait disorders; balance disorders; music; tango; rhythmic auditory stimulation; health-related quality of life

Outcome Measures

Primary Outcomes (1)

• change from baseline in Tinetti scale total score

  4 weeks

Secondary Outcomes (9)

• 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

• change from baseline in Timed Up & Go test (TUG)

  4 weeks

• change from baseline in PDQ-39 scores

  4 weeks

Other Outcomes (8)

• change from baseline in PD CRS

  4 weeks and 6 months

• change from baseline in DRS

  4 weeks and 6 months

• change from baseline in TUG

  6 months

Study Arms (2)

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.

Behavioral: Rhythmic Auditory Stimulation

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.

Behavioral: Kinesiology

Interventions

Rhythmic Auditory Stimulation BEHAVIORAL

Training will be directed to ameliorate gait and balance

Rhythmic auditory stimulation

Kinesiology BEHAVIORAL

Training will be directed to ameliorate gait and balance

Kinesiology

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Previous use of RAS or kinesiology
• MMSE \>= 24
• BDI \>= 17
• Patients having undergone PD surgical treatments.
• Patients with auditory or visual handicaps

Sponsors & Collaborators

• Pontifical Catholic University of Argentina: lead
• National Council of Scientific and Technical Research, Argentina: collaborator
• Hospital Nacional Profesor Alejandro Posadas: collaborator
• University of Buenos Aires: collaborator

MeSH Terms

Conditions

Parkinson Disease; Mobility Limitation

Interventions

Kinesiology, Applied

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both investigators taking care of patients and outcomes assessors will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD CPI

Model Details: randomized, prospective, blind, controlled clinical trial

Study Record Dates

• First Submitted: September 6, 2017
• First Posted: September 11, 2017
• Study Start: March 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share