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
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
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
NCT ID
NCT00498758
First Posted
July 9, 2007
Last Updated
July 9, 2007
Sponsor
Tel-Aviv Sourasky Medical Center
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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