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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00338637
First received: June 19, 2006
Last updated: NA
Last verified: June 2006
History: No changes posted
  Purpose

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 Intervention Phase
Multiple Sclerosis
Balance
Cerebelar Impairment
 Device: APOS shoe kit
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • functional tests

Secondary Outcome Measures:
  • gait analysis

Estimated Enrollment: 30
Study Start Date: April 2006
Estimated Study Completion Date: October 2006
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00338637     History of Changes
Other Study ID Numbers: SHEBA-06-4127-AA-CTIL
Study First Received: June 19, 2006
Last Updated: June 19, 2006
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

ClinicalTrials.gov processed this record on May 21, 2013