Constraint-Induced (CI) Movement Therapy for Progressive... | NCT00695084

Studies
Constraint-Induced (CI) Movement Therapy for Progressive Multiple Sclerosis (MS)

NCT00695084

Sponsor

National Multiple Sclerosis Society

Status

Completed

Last Update Posted

Jun 11, 2008Estimated

Enrollment

7Actual

Phase

Phase 1

Conditions

Multiple Sclerosis

Interventions

Constraint-Induced Movement Therapy

Countries

United States

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

ID	Type	Description	Link
PP1395

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Apr 2008Actual

Completion Date

Apr 2008Actual

First Submitted Date

Jun 9, 2008

First Submission Date that Met QC Criteria

Jun 10, 2008

First Posted Date

Jun 11, 2008Estimated

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

Jun 10, 2008

Last Update Posted Date

Jun 11, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This trial will evaluate whether progressive multiple sclerosis associated with hemiparesis may benefit from Constraint-Induced Movement Therapy.

Detailed Description

Constraint-Induced Movement Therapy was developed to treat stroke hemiparesis. Due to the similarity between multiple sclerosis and stroke in terms of chronic motor deficit, this trial will attempt to determine whether multiple sclerosis may benefit similarly from Constraint-Induced Movement Therapy.

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

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Treatment with Constraint-Induced Movement Therapy	Behavioral: Constraint-Induced Movement Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Constraint-Induced Movement Therapy	Behavioral	Intensive practice with the hemiparetic arm for 30 contact hours	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement on the Motor Activity Log		One year

Secondary Outcomes

Measure	Description	Time Frame
Improvement on the Wolf Motor Function Test		Pre to post-treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chronic upper extremity motor deficit due to multiple sclerosis

Exclusion Criteria:

Relapse within 3 months of planned enrollment.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Victor W Mark, MD	University of Alabama at Birmingham	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35249	United States

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
D000098483	Constraint Induced Movement Therapy

Ancestor Terms

ID	Term
D005081	Exercise Therapy
D026741	Physical Therapy Modalities
D013812	Therapeutics
D012046	Rehabilitation

Browse Leaves

Not provided

Browse Branches

Not provided