Developing and Testing a Comprehensive MS Spasticity Management Program

Multiple Sclerosis Clinical Trial

Official title:

Developing and Testing a Comprehensive MS Spasticity Management Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02170779
• Other study ID #: N1401-P
• Status: Completed
• Phase: Phase 2
• First received: June 9, 2014
• Last updated: August 29, 2016
• Start date: October 2015
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Muscle Spasticity
• Sclerosis
• Spasticity

Intervention

Behavioral:
• Spasticity: Take Control
4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures

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

Locations

Country	Name	City	State
United States	VA Portland Health Care System, Portland, OR	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MS Walking Scale-12 (MSWS-12)	The MSWS-12 is a clinically validated and reliable tool that is flexible and simple enough to use clinically and in research. It captures patients' perspectives on their ambulatory disability on the following: standing, ability to run, need for support, moving around the home, concentration needed to walk, walking speed, maintaining balance, climbing stairs, walking distance, effort needed to walk, ability to walk, and gait. It is simple to administer and responsive to changes in patient performance over time.	at average of 4 months	No
Secondary	Timed 25 Foot Walk	The time to walk 25 feet is strongly related to its ordinal counterpart the Ambulation Index (Spearman r=0.91) without the variability the ordinal scale reflects.	at average of 4 months	No
Secondary	Timed up and go test	The Timed Up and Go (TUG) test measures the time it takes to get up from a chair, walk 10 feet, turn around and return to sit in the chair	at average of 4 months	No
Secondary	6 minute walk test	The subject walks without assistance of another person for 6 minutes and the distance is measured.	at average of 4 months	No
Secondary	Modified Fatigue Impact Scale (MFIS)	This self-report retrospective questionnaire measures fatigue symptoms. It consists of 21 items scored 0-4 for a total score between 0 and 84 and has a coefficient alpha of 0.81. Lower scores on the MFIS indicate less fatigue.	at average of 4 months	No
Secondary	Multiple Sclerosis Impact Scale (MSIS-29)	The MSIS-29 is designed to measure the physical and psychological impact of MS.	at average of 4 months	No
Secondary	Spasticity measured by the modified Ashworth Scale	The modified Ashworth Scale is a standard clinical and research method to quantify spasticity.	at average of 4 months	No
Secondary	Multiple Sclerosis Spasticity Scale - 88 (MSSS-88)	The modified MSSS-88 is a standardized self-report questionnaire to quantify subject's impact of the effects of spasticity.	at average of 4 months	No
Secondary	Beck Depression Inventory II (BDI II)	The BDI-II is a standardized self-report questionnaire to quantify depression.	at average of 4 months	No