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

Sponsor

Tel-Aviv Sourasky Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT00498758

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

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.

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Study Start Date :

Aug 1, 2007

Anticipated Study Completion Date :

Aug 1, 2008

Outcome Measures

Primary Outcome Measures

gait characteristics [3 monthes]
Quality of life [3 monthes]
Mobility [3 monthes]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Tel-Aviv Sourasky Medical Center

Investigators

Principal Investigator: Nir Giladi, MD, Movement Disorders Unit - Tel Aviv Sourasky medical center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00498758

Other Study ID Numbers:

tasmc-07-ng-152-ctil

First Posted:

Jul 10, 2007

Last Update Posted:

Jul 10, 2007

Last Verified:

Jul 1, 2007

Keywords provided by , ,

Additional relevant MeSH terms:

Parkinson Disease

Study Results

No Results Posted as of Jul 10, 2007