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| Name | Class |
|---|---|
| Oregon Health and Science University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A Spasticity: Take Control | Experimental | 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures |
|
| B Usual care | Other | 2 visits: baseline and given usual treatment of brochure for stretching, outcome measures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spasticity: Take Control | Behavioral | 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures |
|
| 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 |
| 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 |
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Inclusion Criteria:
Diagnosis of definite MS
Exclusion Criteria:
Other medical or behavioral conditions that would limit participation or completion of the study.
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| Name | Affiliation | Role |
|---|---|---|
| Lucinda L Hugos, MS | VA Portland Health Care System, Portland, OR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Portland Health Care System, Portland, OR | Portland | Oregon | 97239 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | A Spasticity: Take Control | 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures |
| FG001 | B Usual Care | 2 visits: baseline and given usual treatment of brochure for stretching, outcome measures Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | A Spasticity: Take Control | 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures |
| BG001 | B Usual Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. 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. | Posted | Mean | Standard Deviation | units on a scale | at average of 4 months |
|
2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A Spasticity: Take Control | 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Concussion | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cinda Hugos, Physical Therapist | VA Research and Development | 503-220-8262 | 52338 | hugosc@ohsu.edu |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D009128 | Muscle Spasticity |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Usual care | Other | 2 visits: baseline followed by usual care of brochure for stretching then outcome measures |
|
| 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.
| 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 |
2 visits: baseline and given usual treatment of brochure for stretching, outcome measures Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| A Spasticity: Take Control |
4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures |
| OG001 | B Usual Care | 2 visits: baseline and given usual treatment of brochure for stretching, outcome measures Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures |
|
|
|
| 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. The time is measured and recorded in seconds how long it takes for the participant to walk 25 feet. | One subject was unable to complete this physical assessment at the visit. | Posted | Mean | Standard Deviation | seconds | at average of 4 months |
|
|
|
|
| Secondary | 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. | One subject was unable to complete this physical assessment at the visit. | Posted | Mean | Standard Deviation | seconds | at average of 4 months |
|
|
|
|
| Secondary | 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. | One subject was unable to complete this physical assessment at the visit. | Posted | Mean | Standard Deviation | feet | at average of 4 months |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | at average of 4 months |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | at average of 4 months |
|
|
|
|
| Secondary | 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.
| Posted | Mean | Standard Deviation | units on a scale | at average of 4 months |
|
|
|
|
| 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. 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. | Posted | Mean | Standard Deviation | units on a scale | at average of 4 months |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | at average of 4 months |
|
|
|
|
| 0 |
| 19 |
| 1 |
| 19 |
| EG001 | B Usual Care | 2 visits: baseline and given usual treatment of brochure for stretching, outcome measures Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures | 0 | 19 | 5 | 19 |
| Leg spasms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| UTI | Renal and urinary disorders | Non-systematic Assessment |
|
| Broken arm resulting from fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Pain and bruising from fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Increase in urinary urgency | Renal and urinary disorders | Non-systematic Assessment |
|
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| 0.953 |
| Superiority or Other |