Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00498758
Status:
UNKNOWN
Last Update Posted:
2007-07-10
First Post:
2007-07-09
Brief Title:
The APOS System Effects on Gait Mobility and QOL in Patients With Parkinsons Disease
Sponsor:
Tel-Aviv Sourasky Medical Center
Organization:
Tel-Aviv Sourasky Medical Center
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2007-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Parkinsons disease patients
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None