Trial Outcomes & Findings for Developing and Testing a Comprehensive MS Spasticity Management Program (NCT NCT02170779)

NCT ID: NCT02170779

Last Updated: 2017-03-28

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 40 participants
• Primary outcome timeframe: at average of 4 months
• Results posted on: 2017-03-28

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	20	20
Overall Study COMPLETED	19	19
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	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	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
Overall Study Withdrawal by Subject	1	0
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Developing and Testing a Comprehensive MS Spasticity Management Program

Baseline characteristics by cohort

Measure	A Spasticity: Take Control n=20 Participants 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	B Usual Care n=20 Participants 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	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=93 Participants	18 Participants n=4 Participants	36 Participants n=27 Participants
Age, Categorical >=65 years	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Age, Continuous	53.38 years STANDARD_DEVIATION 12.79 • n=93 Participants	52.83 years STANDARD_DEVIATION 12.34 • n=4 Participants	53.1 years STANDARD_DEVIATION 12.56 • n=27 Participants
Sex: Female, Male Female	13 Participants n=93 Participants	16 Participants n=4 Participants	29 Participants n=27 Participants
Sex: Female, Male Male	7 Participants n=93 Participants	4 Participants n=4 Participants	11 Participants n=27 Participants
Region of Enrollment United States	20 participants n=93 Participants	20 participants n=4 Participants	40 participants n=27 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	A Spasticity: Take Control n=19 Participants 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	B Usual Care n=19 Participants 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
MS Walking Scale-12 (MSWS-12)	72.6 units on a scale Standard Deviation 27.3	82.2 units on a scale Standard Deviation 30.8

SECONDARY outcome

Timeframe: at average of 4 months

Population: One subject was unable to complete this physical assessment at the visit.

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.

Outcome measures

Measure	A Spasticity: Take Control n=19 Participants 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	B Usual Care n=18 Participants 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
Timed 25 Foot Walk	7.6 seconds Standard Deviation 7	9.4 seconds Standard Deviation 10.4

SECONDARY outcome

Timeframe: at average of 4 months

Population: One subject was unable to complete this physical assessment at the visit.

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.

Outcome measures

Measure	A Spasticity: Take Control n=19 Participants 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	B Usual Care n=18 Participants 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
Timed up and go Test	11.23 seconds Standard Deviation 9.69	13.82 seconds Standard Deviation 13.51

SECONDARY outcome

Timeframe: at average of 4 months

Population: One subject was unable to complete this physical assessment at the visit.

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.

Outcome measures

Measure	A Spasticity: Take Control n=19 Participants 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	B Usual Care n=18 Participants 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
2 Minute Walk Test	462.8 feet Standard Deviation 150.5	412.5 feet Standard Deviation 158.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	A Spasticity: Take Control n=19 Participants 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	B Usual Care n=19 Participants 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
Modified Fatigue Impact Scale (MFIS)	41.1 units on a scale Standard Deviation 19.2	43.5 units on a scale Standard Deviation 20.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	A Spasticity: Take Control n=19 Participants 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	B Usual Care n=19 Participants 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
Multiple Sclerosis Impact Scale (MSIS-29) MSIS-29 Physical	45.6 units on a scale Standard Deviation 17.2	52.4 units on a scale Standard Deviation 19.2
Multiple Sclerosis Impact Scale (MSIS-29) MSIS-29 Psychological	18.2 units on a scale Standard Deviation 7.6	20.6 units on a scale Standard Deviation 7.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	A Spasticity: Take Control n=19 Participants 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	B Usual Care n=19 Participants 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
Spasticity Measured by the Modified Ashworth Scale	10.8 units on a scale Standard Deviation 9.5	10.8 units on a scale Standard Deviation 9.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	A Spasticity: Take Control n=19 Participants 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	B Usual Care n=19 Participants 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
Multiple Sclerosis Spasticity Scale - 88 (MSSS-88)	165.7 units on a scale Standard Deviation 53.3	192.4 units on a scale Standard Deviation 58.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	A Spasticity: Take Control n=19 Participants 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	B Usual Care n=19 Participants 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
Beck Depression Inventory II (BDI II)	9 units on a scale Standard Deviation 7.5	11.5 units on a scale Standard Deviation 8

Adverse Events

A Spasticity: Take Control

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

B Usual Care

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	A Spasticity: Take Control n=19 participants at risk 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	B Usual Care n=19 participants at risk 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
Nervous system disorders Concussion	0.00% 0/19 • 2 months	5.3% 1/19 • Number of events 1 • 2 months
Musculoskeletal and connective tissue disorders Leg spasms	5.3% 1/19 • Number of events 1 • 2 months	0.00% 0/19 • 2 months
Renal and urinary disorders UTI	0.00% 0/19 • 2 months	5.3% 1/19 • Number of events 1 • 2 months
Injury, poisoning and procedural complications Broken arm resulting from fall	0.00% 0/19 • 2 months	5.3% 1/19 • Number of events 1 • 2 months
Injury, poisoning and procedural complications Pain and bruising from fall	0.00% 0/19 • 2 months	5.3% 1/19 • Number of events 1 • 2 months
Renal and urinary disorders Increase in urinary urgency	0.00% 0/19 • 2 months	5.3% 1/19 • Number of events 1 • 2 months

Additional Information

Cinda Hugos, Physical Therapist

VA Research and Development

Phone: 503-220-8262

Email: hugosc@ohsu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place