Developing and Testing a Comprehensive MS Spasticity Management Program

NCT ID: NCT02170779

Last Updated: 2017-03-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-06-30

Brief Summary

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This is a study to determine the impact of education and specific lower extremity stretches for MS-related spasticity. The study will evaluate the acceptance and efficacy of education and stretching using a randomized controlled pilot trial.

Detailed Description

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Participants have 2-4 visits depending on program assignment. All participants will have screening/baseline and follow-up visits. Participants in the intervention program will have 2 additional visits with a group of other people with MS to view and discuss the DVDs on spasticity education and stretching for lower extremity MS spasticity and then practice the stretching exercises learned. They will be asked to track exercise electronically and on paper for 4 weeks. Participants will be compensated for participation.

Conditions

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Multiple Sclerosis Spasticity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A Spasticity: Take Control

4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures

Group Type EXPERIMENTAL

Spasticity: Take Control

Intervention Type BEHAVIORAL

4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures

B Usual care

2 visits: baseline and given usual treatment of brochure for stretching, outcome measures

Group Type OTHER

Usual care

Intervention Type OTHER

2 visits: baseline followed by usual care of brochure for stretching then outcome measures

Interventions

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Spasticity: Take Control

4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures

Intervention Type BEHAVIORAL

Usual care

2 visits: baseline followed by usual care of brochure for stretching then outcome measures

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Diagnosis of definite MS

* At least 18 years old
* Able to walk 25 feet independently with common assistive devices if needed
* Presence of spasticity by self-report interfering with usual daily activities
* Have an email account and be familiar with using it
* Willing to track daily exercise for 4 weeks
* Fluent in English

Exclusion Criteria

Other medical or behavioral conditions that would limit participation or completion of the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role collaborator

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lucinda L Hugos, MS

Role: PRINCIPAL_INVESTIGATOR

VA Portland Health Care System, Portland, OR

Locations

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VA Portland Health Care System, Portland, OR

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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N1401-P

Identifier Type: -

Identifier Source: org_study_id

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