Back to resultsMeasuring the Balance Improvement on Multiple Sclerosis Patients After a Short Training Period With an APOS (All Phase Of Step Cycle) Kit
Primary Purpose
Multiple Sclerosis, Balance, Cerebelar Impairment
Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
APOS shoe kit
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria: diagnosis of Multiple sclerosis Cerebellar impairment EDSS under 4.5 age 18-65 years signed informed consent form Exclusion Criteria: pregnancy coronary event in last 6 month 30 days or less after acute attack steroidal treatment in the last 60 days alcohol abuse
Sites / Locations
- Sheba Medical CenterRecruiting
Outcomes
Primary Outcome Measures
functional tests
Secondary Outcome Measures
gait analysis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00338637
Brief Title
Measuring the Balance Improvement on Multiple Sclerosis Patients After a Short Training Period With an APOS (All Phase Of Step Cycle) Kit
Study Type
Interventional
2. Study Status
Record Verification Date
June 2006
Overall Recruitment Status
Unknown status
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sheba Medical Center
4. Oversight
5. Study Description
Brief Summary
Randomised double blind study of two parallel groups,one of the groups trained with the full APOS kit (a shoe with an additional bio mechanical device)
The control group trained with the Apos shoe without the bio mechanical device. both groups will be checked at the beginning of the study, one month later and at the end of the study after two months. The tests include neurological test, functional test(FSST,up and go test and berg balance test) gate analysis and quality fo life (rays) test.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Balance, Cerebelar Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
APOS shoe kit
Primary Outcome Measure Information:
Title
functional tests
Secondary Outcome Measure Information:
Title
gait analysis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of Multiple sclerosis Cerebellar impairment EDSS under 4.5 age 18-65 years signed informed consent form
Exclusion Criteria:
pregnancy
coronary event in last 6 month
30 days or less after acute attack
steroidal treatment in the last 60 days
alcohol abuse
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ofer Gal, Dr.
Phone
972-3-5303932
Email
drofergal@walla.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anat Achiron, Prof.
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center
City
Ramat Gan
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anat Achiron, Prof.
Phone
972-3-5303932
Email
Achiron@post.tau.ac.il
12. IPD Sharing Statement
Learn more about this trial
Measuring the Balance Improvement on Multiple Sclerosis Patients After a Short Training Period With an APOS (All Phase Of Step Cycle) Kit
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