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The APOS System: Effects on Gait, Mobility and QOL in Patients With Parkinson's Disease

Primary Purpose

Idiopathic Parkinson's Disease

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
APOS System - biomechanical wedge shoe
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Parkinson's Disease focused on measuring Parkinson's disease, Gait Disturbances, Mobility, Quality of life

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    gait characteristics
    Quality of life
    Mobility

    Secondary Outcome Measures

    Full Information

    First Posted
    July 9, 2007
    Last Updated
    July 9, 2007
    Sponsor
    Tel-Aviv Sourasky Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00498758
    Brief Title
    The APOS System: Effects on Gait, Mobility and QOL in Patients With Parkinson's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2007
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2007 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    August 2008 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Tel-Aviv Sourasky Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Recently, a biomechanical wedge system was developed for gait and balance training among patients suffering from gait disorders. The APOS system (APOS Medical & Sports Technologies Ltd, Hertzeliya, Israel) applies special semispherical shoes, with individually adjusted implants, to improve age- and disease-related loss in muscle strength and neuromuscular control. The semispherical rubber devices that are placed on the soles of the shoes at the hind-foot and mid-foot can be moved medially, laterally, forwards and backwards. The system can be individually adjusted in order to optimally balance loading and re-train postural control during gait. An additional advantage of this treatment approach is the extraordinary compliance. The system is easily adjusted, maintained, and allows safe gait training. After randomization, all subjects will be fitted with the APOS system, These shoes alter the dynamic balance during all gait cycle phases, adjusting the center of gravity and training postural control. The precise location of the two wedges is adjusted individually by expert trainers using standardized protocols. Subjects in the intervention group will receive a proper wedge; subjects in the sham group will receive an almost flat wedge that lacks the proper biomechanical characteristics. However, both shoes and wedges will look similar. All subjects will be instructed to start gradually, with a goal of reaching 30 minutes of in-home walking while wearing the special training shoes. As an extra pre-caution, all subjects will be asked to walk with the shoes only in the presence of a caregiver, spouse or other family member during the first month. Before moving to more independent training, subjects will be checked for safety.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Idiopathic Parkinson's Disease
    Keywords
    Parkinson's disease, Gait Disturbances, Mobility, Quality of life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    APOS System - biomechanical wedge shoe
    Primary Outcome Measure Information:
    Title
    gait characteristics
    Time Frame
    3 monthes
    Title
    Quality of life
    Time Frame
    3 monthes
    Title
    Mobility
    Time Frame
    3 monthes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Idiopathic Parkinson's disease Stage 2-3 Hoehn & Yahr Exclusion Criteria: Peripheral neuropathic pain Dementia Severe orthopaedic condition c.v.a Hearing or vision loss Usage of walking aid
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Talia Herman
    Email
    talit@tasmc.health.gov.il
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yael Rotem-Galili
    Email
    rotem.yael@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nir Giladi, MD
    Organizational Affiliation
    Movement Disorders Unit - Tel Aviv Sourasky medical center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The APOS System: Effects on Gait, Mobility and QOL in Patients With Parkinson's Disease

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