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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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ClinicalTrials.gov Identifier: NCT00338637
Recruitment Status : Unknown
Verified June 2006 by Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : June 20, 2006
Last Update Posted : June 20, 2006
Sponsor:
Information provided by:
Sheba Medical Center

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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Balance Cerebelar Impairment Device: APOS shoe kit Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : April 2006
Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. functional tests

Secondary Outcome Measures :
  1. gait analysis


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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): NCT00338637


Contacts
Contact: Ofer Gal, Dr. 972-3-5303932 drofergal@walla.com

Locations
Israel
Sheba Medical Center Recruiting
Ramat Gan, Israel
Contact: Anat Achiron, Prof.    972-3-5303932    Achiron@post.tau.ac.il   
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Anat Achiron, Prof. Sheba Medical Center

ClinicalTrials.gov Identifier: NCT00338637     History of Changes
Other Study ID Numbers: SHEBA-06-4127-AA-CTIL
First Posted: June 20, 2006    Key Record Dates
Last Update Posted: June 20, 2006
Last Verified: June 2006

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases