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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00498758
Recruitment Status : Unknown
Verified July 2007 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 10, 2007
Last Update Posted : July 10, 2007
Information provided by:
Tel-Aviv Sourasky Medical Center

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.

Condition or disease Intervention/treatment Phase
Idiopathic Parkinson's Disease Device: APOS System - biomechanical wedge shoe Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : August 2007
Estimated Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. gait characteristics [ Time Frame: 3 monthes ]
  2. Quality of life [ Time Frame: 3 monthes ]
  3. Mobility [ Time Frame: 3 monthes ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00498758

Contact: Talia Herman
Contact: Yael Rotem-Galili

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Principal Investigator: Nir Giladi, MD Movement Disorders Unit - Tel Aviv Sourasky medical center Identifier: NCT00498758     History of Changes
Other Study ID Numbers: tasmc-07-ng-152-ctil
First Posted: July 10, 2007    Key Record Dates
Last Update Posted: July 10, 2007
Last Verified: July 2007

Keywords provided by Tel-Aviv Sourasky Medical Center:
Parkinson's disease
Gait Disturbances
Quality of life

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases