Multiple Sclerosis, Spasticity
Conditions
Keywords
multiple sclerosis, spasticity, stretching, exercise, rehabilitation
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.
Interventions
BEHAVIORALSpasticity: Take Control
4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures
OTHERUsual care
2 visits: baseline followed by usual care of brochure for stretching then outcome measures
Sponsors
Oregon Health and Science University
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MS Walking Scale-12 (MSWS-12) | at average of 4 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Timed up and go Test | at average of 4 months | 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 | at average of 4 months | 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) | at average of 4 months | 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. |
| Timed 25 Foot Walk | at average of 4 months | 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. |
| Spasticity Measured by the Modified Ashworth Scale | at average of 4 months | 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. 1. \- Mild. Barely increased muscle tone. (catch) 2. \- Moderate. Moderately increased muscle tone that can be overcome and full range of motion is possible. (catch and resistance) 3. \- Severe. Severely increased muscle tone that is extremely difficult to overcome and full range of motion is not possible. (resistance and stop) 4. \- 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) | at average of 4 months | 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) | at average of 4 months | 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. |
| Multiple Sclerosis Impact Scale (MSIS-29) | at average of 4 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| 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 | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | B Usual Care | A Spasticity: Take Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 18 Participants | 36 Participants |
| Age, Continuous | 52.83 years STANDARD_DEVIATION 12.34 | 53.38 years STANDARD_DEVIATION 12.79 | 53.1 years STANDARD_DEVIATION 12.56 |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 16 Participants | 13 Participants | 29 Participants |
| Sex: Female, Male Male | 4 Participants | 7 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 19 | 5 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 |
Outcome results
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.
Time frame: at average of 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Spasticity: Take Control | MS Walking Scale-12 (MSWS-12) | 72.6 units on a scale | Standard Deviation 27.3 |
| B Usual Care | MS Walking Scale-12 (MSWS-12) | 82.2 units on a scale | Standard Deviation 30.8 |
p-value: 0.84Wilcoxon (Mann-Whitney)
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.
Time frame: at average of 4 months
Population: One subject was unable to complete this physical assessment at the visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Spasticity: Take Control | 2 Minute Walk Test | 462.8 feet | Standard Deviation 150.5 |
| B Usual Care | 2 Minute Walk Test | 412.5 feet | Standard Deviation 158.7 |
p-value: 0.638Wilcoxon (Mann-Whitney)
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.
Time frame: at average of 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Spasticity: Take Control | Beck Depression Inventory II (BDI II) | 9 units on a scale | Standard Deviation 7.5 |
| B Usual Care | Beck Depression Inventory II (BDI II) | 11.5 units on a scale | Standard Deviation 8 |
p-value: 0.11Wilcoxon (Mann-Whitney)
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.
Time frame: at average of 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Spasticity: Take Control | Modified Fatigue Impact Scale (MFIS) | 41.1 units on a scale | Standard Deviation 19.2 |
| B Usual Care | Modified Fatigue Impact Scale (MFIS) | 43.5 units on a scale | Standard Deviation 20.8 |
p-value: 0.492Wilcoxon (Mann-Whitney)
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.
Time frame: at average of 4 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| A Spasticity: Take Control | Multiple Sclerosis Impact Scale (MSIS-29) | MSIS-29 Physical | 45.6 units on a scale | Standard Deviation 17.2 |
| A Spasticity: Take Control | Multiple Sclerosis Impact Scale (MSIS-29) | MSIS-29 Psychological | 18.2 units on a scale | Standard Deviation 7.6 |
| B Usual Care | Multiple Sclerosis Impact Scale (MSIS-29) | MSIS-29 Physical | 52.4 units on a scale | Standard Deviation 19.2 |
| B Usual Care | Multiple Sclerosis Impact Scale (MSIS-29) | MSIS-29 Psychological | 20.6 units on a scale | Standard Deviation 7.6 |
Comparison: This analysis refers to the physical component of the MSIS-29p-value: 0.144Wilcoxon (Mann-Whitney)
Comparison: This refers to the psychological analysis for the MSIS-29.p-value: 0.953Wilcoxon (Mann-Whitney)
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.
Time frame: at average of 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Spasticity: Take Control | Multiple Sclerosis Spasticity Scale - 88 (MSSS-88) | 165.7 units on a scale | Standard Deviation 53.3 |
| B Usual Care | Multiple Sclerosis Spasticity Scale - 88 (MSSS-88) | 192.4 units on a scale | Standard Deviation 58.8 |
p-value: 0.023Wilcoxon (Mann-Whitney)
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. 1. \- Mild. Barely increased muscle tone. (catch) 2. \- Moderate. Moderately increased muscle tone that can be overcome and full range of motion is possible. (catch and resistance) 3. \- Severe. Severely increased muscle tone that is extremely difficult to overcome and full range of motion is not possible. (resistance and stop) 4. \- 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Spasticity: Take Control | Spasticity Measured by the Modified Ashworth Scale | 10.8 units on a scale | Standard Deviation 9.5 |
| B Usual Care | Spasticity Measured by the Modified Ashworth Scale | 10.8 units on a scale | Standard Deviation 9.3 |
p-value: 0.915Wilcoxon (Mann-Whitney)
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.
Time frame: at average of 4 months
Population: One subject was unable to complete this physical assessment at the visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Spasticity: Take Control | Timed 25 Foot Walk | 7.6 seconds | Standard Deviation 7 |
| B Usual Care | Timed 25 Foot Walk | 9.4 seconds | Standard Deviation 10.4 |
p-value: 0.738Wilcoxon (Mann-Whitney)
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.
Time frame: at average of 4 months
Population: One subject was unable to complete this physical assessment at the visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Spasticity: Take Control | Timed up and go Test | 11.23 seconds | Standard Deviation 9.69 |
| B Usual Care | Timed up and go Test | 13.82 seconds | Standard Deviation 13.51 |
p-value: 0.8434Wilcoxon (Mann-Whitney)