NCT00498758

Brief Summary

The purpose of this study is to evaluate the benefits of a biomechanical wedge system - The APOS system, for improving the stability of gait, mobility and quality of life in Parkinson's disease patients.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2007

Shorter than P25 for phase_2

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

First Submitted

Initial submission to the registry

July 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 10, 2007

Completed
22 days until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

July 10, 2007

Status Verified

July 1, 2007

First QC Date

July 9, 2007

Last Update Submit

July 9, 2007

Conditions

Idiopathic Parkinson's Disease

Keywords

Parkinson's diseaseGait DisturbancesMobilityQuality of life

Outcome Measures

Primary Outcomes (3)

  • gait characteristics

    3 monthes

  • Quality of life

    3 monthes

  • Mobility

    3 monthes

Interventions

APOS System - biomechanical wedge shoeDEVICE

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Idiopathic Parkinson's disease
  • Stage 2-3 Hoehn \& Yahr

You may not qualify if:

  • Peripheral neuropathic pain
  • Dementia
  • Severe orthopaedic condition
  • c.v.a
  • Hearing or vision loss
  • Usage of walking aid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson DiseaseMobility Limitation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nir Giladi, MD

    Movement Disorders Unit - Tel Aviv Sourasky medical center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Talia Herman

CONTACT

talit@tasmc.health.gov.il

Yael Rotem-Galili

CONTACT

rotem.yael@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 9, 2007

First Posted

July 10, 2007

Study Start

August 1, 2007

Study Completion

August 1, 2008

Last Updated

July 10, 2007

Record last verified: 2007-07