NCT00716261

Brief Summary

Our hypothesis is that intensive training with positive biofeedback may enhance postural control and stability in Parkinson's disease patients and in elderly fallers.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

July 16, 2008

Status Verified

July 1, 2008

Enrollment Period

1.7 years

First QC Date

July 14, 2008

Last Update Submit

July 15, 2008

Conditions

Parkinson's Disease Patients

Keywords

Parkinson's diseaseAudio feedbackpostural control

Interventions

McROB Hybrid node 3-axes accelerometers and 3-axes gyroscopesDEVICE

Training with the Audio-feedback device for about 30 minutes, 3 times per week for 6 weeks

Also known as: AUDIO-BIOFEEDBACK SYSTEM, DEIS, Università di Bologna, Bologna, Italy(Chiari et al., 2005)

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Idiopathic PD for \>2 yrs
  • Between 50-90 Yrs
  • On anti-Parkinsonian medication
  • Hoehn \& Yahr 2-3 in "ON"
  • Free of serious co-morbidities
  • Able to walk but reports difficulties in gait
  • Can use assistive device

You may not qualify if:

  • Significant orthopedic disturbances or pain
  • Major depression (DSM IV)
  • Dementia (MMSE\<24)
  • Clinically significant hearing problems
  • Unstable medical condition (2 wks from meds change)
  • Deep Brain Stimulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory for gait and neurodynamics, Tel-Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jeffrey M Hausdorff, PhD

    Laboratory for gait and neurodynamics, Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 14, 2008

First Posted

July 16, 2008

Study Start

January 1, 2008

Primary Completion

September 1, 2009

Study Completion

November 1, 2009

Last Updated

July 16, 2008

Record last verified: 2008-07

Locations

IL(1)