Developing and Testing a Comprehensive MS Spasticity Management Program

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT02170779
• Collaborator: Oregon Health and Science University (Other)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 8
• Patients Per Site Per Month: 5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis; Spasticity	Behavioral: Spasticity: Take Control; Other: Usual care	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Developing and Testing a Comprehensive MS Spasticity Management Program
• Study Start Date: Oct 1, 2015
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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. - 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.

7. 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.

8. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Portland Health Care System, Portland, OR	Portland	Oregon	United States	97239

Sponsors and Collaborators

• VA Office of Research and Development
• Oregon Health and Science University

Investigators

• Principal Investigator: Lucinda L Hugos, MS, VA Portland Health Care System, Portland, OR

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02170779
• Other Study ID Numbers: N1401-P
• First Posted: Jun 23, 2014
• Last Update Posted: Mar 28, 2017
• Last Verified: Feb 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by VA Office of Research and Development: multiple sclerosis; spasticity; stretching; exercise; rehabilitation
• Additional relevant MeSH terms: Muscle Spasticity; Multiple Sclerosis; Sclerosis

Study Results

Participant Flow

Arm/Group Title	A Spasticity: Take Control	B Usual Care
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	20	20
COMPLETED	19	19
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	A Spasticity: Take Control	B Usual Care	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	20	20	40
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	18 90%	18 90%	36 90%
>=65 years	2 10%	2 10%	4 10%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.38 (12.79)	52.83 (12.34)	53.1 (12.56)
Sex: Female, Male (Count of Participants)
Female	13 65%	16 80%	29 72.5%
Male	7 35%	4 20%	11 27.5%
Region of Enrollment (participants) [Number]
United States	20 100%	20 100%	40 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	A Spasticity: Take Control	B Usual Care
Arm/Group Description	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	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
Measure Participants	19	19
Mean (Standard Deviation) [units on a scale]	72.6 (27.3)	82.2 (30.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	A Spasticity: Take Control, B Usual Care
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.84
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	A Spasticity: Take Control	B Usual Care
Arm/Group Description	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	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
Measure Participants	19	18
Mean (Standard Deviation) [seconds]	7.6 (7)	9.4 (10.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	A Spasticity: Take Control, B Usual Care
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.738
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	A Spasticity: Take Control	B Usual Care
Arm/Group Description	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	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
Measure Participants	19	18
Mean (Standard Deviation) [seconds]	11.23 (9.69)	13.82 (13.51)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	A Spasticity: Take Control, B Usual Care
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8434
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	A Spasticity: Take Control	B Usual Care
Arm/Group Description	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	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
Measure Participants	19	18
Mean (Standard Deviation) [feet]	462.8 (150.5)	412.5 (158.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	A Spasticity: Take Control, B Usual Care
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.638
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	A Spasticity: Take Control	B Usual Care
Arm/Group Description	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	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
Measure Participants	19	19
Mean (Standard Deviation) [units on a scale]	41.1 (19.2)	43.5 (20.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	A Spasticity: Take Control, B Usual Care
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.492
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	A Spasticity: Take Control	B Usual Care
Arm/Group Description	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	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
Measure Participants	19	19
MSIS-29 Physical	45.6 (17.2)	52.4 (19.2)
MSIS-29 Psychological	18.2 (7.6)	20.6 (7.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	A Spasticity: Take Control, B Usual Care
	Comments	This analysis refers to the physical component of the MSIS-29
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.144
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	A Spasticity: Take Control, B Usual Care
	Comments	This refers to the psychological analysis for the MSIS-29.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.953
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	A Spasticity: Take Control	B Usual Care
Arm/Group Description	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	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
Measure Participants	19	19
Mean (Standard Deviation) [units on a scale]	10.8 (9.5)	10.8 (9.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	A Spasticity: Take Control, B Usual Care
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.915
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	A Spasticity: Take Control	B Usual Care
Arm/Group Description	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	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
Measure Participants	19	19
Mean (Standard Deviation) [units on a scale]	165.7 (53.3)	192.4 (58.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	A Spasticity: Take Control, B Usual Care
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.023
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	A Spasticity: Take Control	B Usual Care
Arm/Group Description	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	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
Measure Participants	19	19
Mean (Standard Deviation) [units on a scale]	9 (7.5)	11.5 (8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	A Spasticity: Take Control, B Usual Care
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.11
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Time Frame	2 months
Arm/Group Title	A Spasticity: Take Control		B Usual Care
Arm/Group Description	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		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
All Cause Mortality
	A Spasticity: Take Control		B Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	A Spasticity: Take Control		B Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	A Spasticity: Take Control		B Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/19 (5.3%)		5/19 (26.3%)
Injury, poisoning and procedural complications
Broken arm resulting from fall	0/19 (0%)	0	1/19 (5.3%)	1
Pain and bruising from fall	0/19 (0%)	0	1/19 (5.3%)	1
Musculoskeletal and connective tissue disorders
Leg spasms	1/19 (5.3%)	1	0/19 (0%)	0
Nervous system disorders
Concussion	0/19 (0%)	0	1/19 (5.3%)	1
Renal and urinary disorders
UTI	0/19 (0%)	0	1/19 (5.3%)	1
Increase in urinary urgency	0/19 (0%)	0	1/19 (5.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.