Developing and Testing a Comprehensive MS Spasticity Management Program
Primary Purpose
Multiple Sclerosis, Spasticity
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Spasticity: Take Control
Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis, spasticity, stretching, exercise, rehabilitation
Eligibility Criteria
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.
Sites / Locations
- VA Portland Health Care System, Portland, OR
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
A Spasticity: Take Control
B Usual care
Arm Description
4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures
2 visits: baseline and given usual treatment of brochure for stretching, outcome measures
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT02170779
First Posted
June 9, 2014
Last Updated
February 7, 2017
Sponsor
VA Office of Research and Development
Collaborators
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT02170779
Brief Title
Developing and Testing a Comprehensive MS Spasticity Management Program
Official Title
Developing and Testing a Comprehensive MS Spasticity Management Program
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Oregon Health and Science University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Spasticity
Keywords
multiple sclerosis, spasticity, stretching, exercise, rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A Spasticity: Take Control
Arm Type
Experimental
Arm Description
4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures
Arm Title
B Usual care
Arm Type
Other
Arm Description
2 visits: baseline and given usual treatment of brochure for stretching, outcome measures
Intervention Type
Behavioral
Intervention Name(s)
Spasticity: Take Control
Intervention Description
4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
2 visits: baseline followed by usual care of brochure for stretching then outcome measures
Primary Outcome Measure Information:
Title
MS Walking Scale-12 (MSWS-12)
Description
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.
Time Frame
at average of 4 months
Secondary Outcome Measure Information:
Title
Timed 25 Foot Walk
Description
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.
Time Frame
at average of 4 months
Title
Timed up and go Test
Description
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.
Time Frame
at average of 4 months
Title
2 Minute Walk Test
Description
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.
Time Frame
at average of 4 months
Title
Modified Fatigue Impact Scale (MFIS)
Description
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.
Time Frame
at average of 4 months
Title
Multiple Sclerosis Impact Scale (MSIS-29)
Description
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.
Time Frame
at average of 4 months
Title
Spasticity Measured by the Modified Ashworth Scale
Description
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.
Time Frame
at average of 4 months
Title
Multiple Sclerosis Spasticity Scale - 88 (MSSS-88)
Description
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.
Time Frame
at average of 4 months
Title
Beck Depression Inventory II (BDI II)
Description
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.
Time Frame
at average of 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucinda L Hugos, MS
Organizational Affiliation
VA Portland Health Care System, Portland, OR
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Portland Health Care System, Portland, OR
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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