Idiopathic Parkinson's Disease Clinical Trial
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.
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.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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