The APOS System: Effects on Gait, Mobility and QOL in Patients With Parkinson's Disease
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|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Parkinson's Disease||Device: APOS System - biomechanical wedge shoe||Phase 2|
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|
|Intervention Model:||Parallel Assignment|
|Study Start Date :||August 2007|
|Estimated Study Completion Date :||August 2008|
- gait characteristics [ Time Frame: 3 monthes ]
- Quality of life [ Time Frame: 3 monthes ]
- Mobility [ Time Frame: 3 monthes ]
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 ClinicalTrials.gov identifier (NCT number): NCT00498758
|Principal Investigator:||Nir Giladi, MD||Movement Disorders Unit - Tel Aviv Sourasky medical center|