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NCT00338637 Clinical Trial

Measuring the Balance Improvement on Multiple Sclerosis Patients After a Short Training Period With an APOS (All Phase Of Step Cycle) Kit

Multiple Sclerosis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00338637
Other study ID # SHEBA-06-4127-AA-CTIL
Secondary ID
Status Recruiting
Phase Phase 2
First received June 19, 2006
Last updated June 19, 2006
Start date April 2006
Est. completion date October 2006

Study information
Verified date June 2006
Source Sheba Medical Center
Contact Ofer Gal, Dr.
Phone 972-3-5303932
Email drofergal@walla.com
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date October 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• APOS shoe kit

Locations
Country Name City State
Israel Sheba Medical Center Ramat Gan

Sponsors (1)
Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary functional tests
Secondary gait analysis
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