Gait Evaluation in Multiple Sclerosis Patients Treated Wi... | NCT00331747

Studies
Gait Evaluation in Multiple Sclerosis Patients Treated With Glatiramer Acetate

NCT00331747

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Jul 7, 2006Estimated

Enrollment

Phase

Not Applicable

Conditions

Multiple Sclerosis

Interventions

Glatiramer acetate

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

May 30, 2006

First Submission Date that Met QC Criteria

May 30, 2006

First Posted Date

May 31, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 5, 2006

Last Update Posted Date

Jul 7, 2006Estimated

Description Module

Brief Summary

Hypothesis: Treatment with Glatiramer acetate prevents deterioration of gait in multiple sclerosis (MS) patients.

During the study patients will undergo a 3 dimensional gait analysis before starting treatment with glatiramer acetate and after 1 year of treatment.

Detailed Description

Patients with a definite diagnosis of relapsing remitting multiple sclerosis (MS) will undergo a 3 dimensional gait analysis before initiation of treatment with glatiramer acetate. The gait analysis will include kinematic evaluation using a Charnwood Dynamics CODA CX-1 system, 4 AMTI force plates and a Noraxon telemetric EMG system. Patients will be videotaped and will also undergo a detailed physical examination by a physical therapist.

Treatment with Glatiramer acetate will be initiated after the gait analysis. Therapy will be observed and controlled by a neurologist fromn the staff of the Multiple Sclerosis Center.

Repeat gait analysis will be performed after one year of treatment.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Glatiramer acetate	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Computerized gait analysis: at the beginning of treatment and after 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of multiple sclerosis
EDSS less than 5.5
No cognitive disability

Exclusion Criteria:

EDSS over 5.5
Inability to cooperate with gait analysis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Uri Givon, MD	Contact	+972-35304451		urigi@sheba.health.gov.il

Overall Officials

Name	Affiliation	Role
Uri Givon, MD	Sheba Medical Center; Tel Aviv University	Principal Investigator
Anat Achiron, MD, PhD	Sheba Medical Center; Tel Aviv University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Multiple Sclerosis Center, Sheba Medical Center	Recruiting	Tel Litwinsky		52621	Israel

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068717	Glatiramer Acetate

Ancestor Terms

ID	Term
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided