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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00498758
First received: July 9, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  Purpose

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 Intervention Phase
Idiopathic Parkinson's Disease
Device: APOS System - biomechanical wedge shoe
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

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

Estimated Enrollment: 60
Study Start Date: August 2007
Estimated Study Completion Date: August 2008
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.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00498758

Contacts
Contact: Talia Herman talit@tasmc.health.gov.il
Contact: Yael Rotem-Galili rotem.yael@gmail.com

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Nir Giladi, MD Movement Disorders Unit - Tel Aviv Sourasky medical center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00498758     History of Changes
Other Study ID Numbers: tasmc-07-ng-152-ctil
Study First Received: July 9, 2007
Last Updated: July 9, 2007
Health Authority: Israel: Ethics Commission

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

ClinicalTrials.gov processed this record on September 11, 2014