NCT01960985

Brief Summary

Verifying the efficiency of motor training associated with visual and auditory cues on the balance, and postural anticipatory and compensatory adjustments of patients with Parkinson's Disease (PD), for prevent fall rate in people with PD. It is a single blinded, randomized clinical trial performed at Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2006

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 11, 2013

Completed
Last Updated

June 30, 2015

Status Verified

October 1, 2013

Enrollment Period

2.3 years

First QC Date

August 30, 2013

Last Update Submit

June 29, 2015

Conditions

Disturbance; Balance, LabyrinthParkinson´s Disease

Keywords

Balance, PosturalParkinson´s DiseaseH&Y 1-3ExrecicePostural adjustmentsantecipatory posturalcompensatory postural adjustments

Outcome Measures

Primary Outcomes (1)

  • UPDRS

    The Unified Parkinson's Disease Rating Scale (UPDRS) is a rating scale used to follow the longitudinal course of Parkinson's disease

    up to 30 weeks

Secondary Outcomes (5)

  • Berg Balance Scale (BBS) Berg Balance Scale

    up to 30 weeks

  • Dynamic Gait Index

    up to 30 weeks

  • Retropulsion test

    up to 30 weeks

  • Timed Up and Go test (TUG)

    up to 30 weeks

  • Balance Evaluation Systems Test (BESTest)

    up to 30 weeks

Study Arms (2)

Physicaltherapy

EXPERIMENTAL

Exprerimental group I - motor training balance training Exprerimental group II - motor training associated with visual and auditory cues on the balance training Control group - recived general orientations.

Other: Physicaltherapy

physiotherapy

EXPERIMENTAL

Exprerimental group I - motor training balance training Exprerimental group II - motor training associated with visual and auditory cues on the balance training Control group - recived general orientations.

Other: Physicaltherapy

Interventions

PhysicaltherapyOTHER
Also known as: balance training
Physicaltherapyphysiotherapy

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Elderly
  • The patient is able to provide informed consent.
  • Definitive Idiopathic Parkinson's Disease as diagnosed by a Neurologist
  • Hoehn and Yahr Stage 1-3
  • Able to ambulate without an assistive device
  • On stable doses of Parkinson's medications prior to study onset

You may not qualify if:

  • Mini Mental Status Exam (MMSE) \< 24
  • Change in Parkinson's medications in the duration of study
  • Uncontrolled orthostasis
  • Symptomatic coronary artery disease
  • Fracture of lower limb prior to study onset
  • Other neurologic diagnosis
  • Physical therapy before and during to study duration
  • Significant camptocormia
  • Any medical condition which the physician investigator determines would compromise the safety of exercise program for the subject.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo Clinical Hospital

São Paulo, São Paulo, Brazil

Location

Related Publications (2)

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

    PMID: 38588457DERIVED

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

    PMID: 36602886DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Tamine Capato, Master

    University of Sao Paulo HCFMUSP

    PRINCIPAL INVESTIGATOR

  • Maria Elisa Piemonte, PhG

    University of Sao Paulo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2013

First Posted

October 11, 2013

Study Start

August 1, 2006

Primary Completion

December 1, 2008

Study Completion

August 1, 2012

Last Updated

June 30, 2015

Record last verified: 2013-10

Locations

BR(1)