Developing and Testing a Comprehensive MS Spasticity Management Program

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Spasticity
• Intervention / Treatment: Behavioral: Spasticity: Take Control; Other: Usual care

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • VA Portland Health Care System, Portland, OR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A Spasticity: Take Control; 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures	Behavioral: Spasticity: Take Control; 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures
Other: B Usual care; 2 visits: baseline and given usual treatment of brochure for stretching, outcome measures	Other: Usual care; 2 visits: baseline followed by usual care of brochure for stretching then outcome measures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. Individual items are scored on a 5 point Likert scale: 1 (Not at all), 2 (A little), 3 (Moderately), 4 (Quite a bit), 5 (Extremely). A total score is generated and reported on a 0 to 100 scale by subtracting the minimum score possible (12) from the patient's score, dividing by the maximum score possible minus the minimum possible (60-12, or 48), and multiplying. Higher values represent a worse outcome and greater disability.	at average of 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. The time is measured and recorded in seconds how long it takes for the participant to walk 25 feet.	at average of 4 months
Timed up and go Test	The Timed Up and Go (TUG) test measures the time in seconds it takes to get up from a chair, walk 10 feet, turn around and return to sit in the chair. The best score of the two attempts was analyzed.	at average of 4 months
2 Minute Walk Test	The subject walks without assistance of another person for 2 minutes. The distance in feet the individual was able to walk in 2 minutes is then measured.	at average of 4 months
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
Multiple Sclerosis Impact Scale (MSIS-29)	The MSIS-29 is designed to measure the physical and psychological impact of MS. Each subscale summed separately. No total calculated. Scores transformed to have a range of 0-100. Lower scores indicate less impact, higher scores indicate higher impact.	at average of 4 months
Spasticity Measured by the Modified Ashworth Scale	The modified Ashworth Scale is a standard clinical and research method to quantify spasticity. Each of the 6 leg groups is given a scale of 0-4. 0 - Normal. No increase in muscle tone.; - Mild. Barely increased muscle tone. (catch); - Moderate. Moderately increased muscle tone that can be overcome and full range of motion is possible. (catch and resistance); - Severe. Severely increased muscle tone that is extremely difficult to overcome and full range of motion is not possible. (resistance and stop); - Contracted. All groups are summed for a total score for each side of the body. Higher scores indicate greater spasticity. Lowest possible score is a 0 whereas the highest possible score for each side is 24.	at average of 4 months
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. The 88 questions each have a possible score of 1-4. All questions are totaled for a final total scores. Higher scores indicate greater spasticity. The lowest score is 88 and the highest possible is 352.	at average of 4 months
Beck Depression Inventory II (BDI II)	The BDI-II is a standardized self-report questionnaire to quantify depression. The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Answers to 21 questions added together. Higher scores indicate greater depression. Lowest possible score is a 0 whereas highest 63.	at average of 4 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Oregon Health and Science University
• Investigators: Principal Investigator: Lucinda L Hugos, MS, VA Portland Health Care System, Portland, OR

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: June 9, 2014
• First Submitted That Met QC Criteria: June 20, 2014
• First Posted (Estimate): June 23, 2014

Study Record Updates

• Last Update Posted (Actual): March 28, 2017
• Last Update Submitted That Met QC Criteria: February 7, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: exercise; rehabilitation; multiple sclerosis; spasticity; stretching
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Multiple Sclerosis; Sclerosis; Muscle Spasticity
• Other Study ID Numbers: N1401-P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No