NCT00695084

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1 multiple-sclerosis

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_1 multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2008

Completed
Last Updated

June 11, 2008

Status Verified

June 1, 2008

Enrollment Period

1.1 years

First QC Date

June 9, 2008

Last Update Submit

June 10, 2008

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis

Outcome Measures

Primary Outcomes (1)

  • Improvement on the Motor Activity Log

    One year

Secondary Outcomes (1)

  • Improvement on the Wolf Motor Function Test

    Pre to post-treatment

Study Arms (1)

1

EXPERIMENTAL

Treatment with Constraint-Induced Movement Therapy

Behavioral: Constraint-Induced Movement Therapy

Interventions

Constraint-Induced Movement TherapyBEHAVIORAL

Intensive practice with the hemiparetic arm for 30 contact hours

Also known as: CI Therapy
1

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic upper extremity motor deficit due to multiple sclerosis

You may not qualify if:

  • Relapse within 3 months of planned enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Victor W Mark, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 9, 2008

First Posted

June 11, 2008

Study Start

March 1, 2007

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

June 11, 2008

Record last verified: 2008-06

Locations

US(1)