Trial Outcomes & Findings for Evaluation of a Spasticity Management Program for People With Multiple Sclerosis (NCT NCT03166930)
NCT ID: NCT03166930
Last Updated: 2026-03-11
Results Overview
Impact of spasticity will be measured using the Multiple Sclerosis Spasticity Scale-88 at one month post intervention. Minimum score = 88. Maximum score = 352. A higher score is a worse outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
232 participants
Primary outcome timeframe
One month post-intervention
Results posted on
2026-03-11
Participant Flow
493 approached and completed final screening. 261 didn't meet inclusion criteria or were unable to participate, 232 were consented, 1 excluded after consent because no baseline questionnaires.
Participant milestones
| Measure |
Spasticity Take Control
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.
Spasticity Take Control: Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.
|
Stretching for People With MS: An Illustrated Manual
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management.
Stretching for People with MS: An Illustrated Manual: Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management from the manual.
|
|---|---|---|
|
Overall Study
STARTED
|
116
|
115
|
|
Overall Study
Completed Classes
|
106
|
108
|
|
Overall Study
Completed 1 Month Outcomes
|
105
|
105
|
|
Overall Study
Completed 6 Month Outcomes
|
97
|
97
|
|
Overall Study
COMPLETED
|
109
|
107
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
Reasons for withdrawal
| Measure |
Spasticity Take Control
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.
Spasticity Take Control: Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.
|
Stretching for People With MS: An Illustrated Manual
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management.
Stretching for People with MS: An Illustrated Manual: Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management from the manual.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
8
|
Baseline Characteristics
Includes only participants that provided an outcome measurement at 1 and/or 6 months
Baseline characteristics by cohort
| Measure |
Spasticity Take Control
n=116 Participants
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.
Spasticity Take Control: Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.
|
Stretching for People With MS: An Illustrated Manual
n=115 Participants
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management.
Stretching for People with MS: An Illustrated Manual: Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management from the manual.
|
Total
n=231 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.11 Years
STANDARD_DEVIATION 11.1 • n=116 Participants
|
53.68 Years
STANDARD_DEVIATION 12.05 • n=115 Participants
|
54.4 Years
STANDARD_DEVIATION 11.6 • n=231 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=116 Participants
|
99 Participants
n=115 Participants
|
199 Participants
n=231 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=116 Participants
|
16 Participants
n=115 Participants
|
32 Participants
n=231 Participants
|
|
Race/Ethnicity, Customized
White
|
104 Participants
n=116 Participants
|
100 Participants
n=115 Participants
|
204 Participants
n=231 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
4 Participants
n=116 Participants
|
8 Participants
n=115 Participants
|
12 Participants
n=231 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
112 Participants
n=116 Participants
|
107 Participants
n=115 Participants
|
219 Participants
n=231 Participants
|
|
Race/Ethnicity, Customized
Race Unknown
|
12 Participants
n=116 Participants
|
15 Participants
n=115 Participants
|
27 Participants
n=231 Participants
|
|
Region of Enrollment
United States
|
116 Participants
n=116 Participants
|
115 Participants
n=115 Participants
|
231 Participants
n=231 Participants
|
|
Multiple Sclerosis Spasticity Scale - 88
|
195.53 units on a scale
STANDARD_DEVIATION 53.82 • n=109 Participants • Includes only participants that provided an outcome measurement at 1 and/or 6 months
|
189.05 units on a scale
STANDARD_DEVIATION 48.64 • n=107 Participants • Includes only participants that provided an outcome measurement at 1 and/or 6 months
|
192.3 units on a scale
STANDARD_DEVIATION 51.2 • n=216 Participants • Includes only participants that provided an outcome measurement at 1 and/or 6 months
|
PRIMARY outcome
Timeframe: One month post-interventionImpact of spasticity will be measured using the Multiple Sclerosis Spasticity Scale-88 at one month post intervention. Minimum score = 88. Maximum score = 352. A higher score is a worse outcome.
Outcome measures
| Measure |
Spasticity Take Control
n=105 Participants
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.
Spasticity Take Control: Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.
|
Stretching for People With MS: An Illustrated Manual
n=105 Participants
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management.
Stretching for People with MS: An Illustrated Manual: Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management from the manual.
|
|---|---|---|
|
Impact of Spasticity, Measured by the Multiple Sclerosis Spasticity Scale-88
|
-16.11 units on a scale
Standard Deviation 34.14
|
-15.83 units on a scale
Standard Deviation 37.33
|
PRIMARY outcome
Timeframe: Six months post-interventionImpact of spasticity will be measured using the Multiple Sclerosis Spasticity Scale-88 at six months post intervention. Minimum score = 88. Maximum score = 352. A higher score is a worse outcome.
Outcome measures
| Measure |
Spasticity Take Control
n=97 Participants
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.
Spasticity Take Control: Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.
|
Stretching for People With MS: An Illustrated Manual
n=97 Participants
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management.
Stretching for People with MS: An Illustrated Manual: Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management from the manual.
|
|---|---|---|
|
Impact of Spasticity, Measured by the Multiple Sclerosis Spasticity Scale-88
|
-23.25 units on a scale
Standard Deviation 38.96
|
-24.11 units on a scale
Standard Deviation 41.20
|
SECONDARY outcome
Timeframe: One month post-interventionSeverity of spasticity will be measured using the Numeric Rating Scale for Spasticity at one month post intervention. Minimum score = 0. Maximum score = 10. A higher score is a worse outcome.
Outcome measures
| Measure |
Spasticity Take Control
n=105 Participants
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.
Spasticity Take Control: Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.
|
Stretching for People With MS: An Illustrated Manual
n=105 Participants
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management.
Stretching for People with MS: An Illustrated Manual: Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management from the manual.
|
|---|---|---|
|
Severity of Spasticity, Measured by the Numeric Rating Scale for Spasticity
|
-0.41 units on a scale
Standard Deviation 2.38
|
-0.45 units on a scale
Standard Deviation 2.14
|
SECONDARY outcome
Timeframe: One month post-interventionFatigue will be measured using the Modified Fatigue Impact Scale at one month post intervention. Minimum score = 0. Maximum score = 84. A higher score is a worse outcome.
Outcome measures
| Measure |
Spasticity Take Control
n=105 Participants
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.
Spasticity Take Control: Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.
|
Stretching for People With MS: An Illustrated Manual
n=105 Participants
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management.
Stretching for People with MS: An Illustrated Manual: Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management from the manual.
|
|---|---|---|
|
Fatigue, Measured by the Modified Fatigue Impact Scale
|
-6.24 units on a scale
Standard Deviation 11.35
|
-5.16 units on a scale
Standard Deviation 10.38
|
SECONDARY outcome
Timeframe: One month post-interventionSleep quality and quantity will be measured using Pittsburgh Sleep Quality Index at one month post intervention. Minimum score = 0. Maximum score = 21. A higher score is a worse outcome.
Outcome measures
| Measure |
Spasticity Take Control
n=105 Participants
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.
Spasticity Take Control: Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.
|
Stretching for People With MS: An Illustrated Manual
n=105 Participants
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management.
Stretching for People with MS: An Illustrated Manual: Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management from the manual.
|
|---|---|---|
|
Sleep Quality and Quantity, Measured by the Pittsburgh Sleep Quality Index
|
-0.69 units on a scale
Standard Deviation 2.88
|
-0.31 units on a scale
Standard Deviation 2.60
|
SECONDARY outcome
Timeframe: One month post-interventionImpact on day-to-day life, measured by the Multiple Sclerosis Impact Scale-29 at one month post intervention. The 29-item self-report measures the physical and psychological impact of MS from the patient's perspective through two subscales. The 29 items are divided into a 20 item physical scale and 9 item psychological scale, with each each scored between 1 (not at all impactful) and 5 (extremely impactful). Totaled minimum score = 29. Totaled maximum score = 145. The Psychological subscale (9 items) ranging from 9 to 45, and the Physical subscale (20 items) ranging from 20 to 100. A higher score is a worse outcome.
Outcome measures
| Measure |
Spasticity Take Control
n=105 Participants
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.
Spasticity Take Control: Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.
|
Stretching for People With MS: An Illustrated Manual
n=105 Participants
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management.
Stretching for People with MS: An Illustrated Manual: Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management from the manual.
|
|---|---|---|
|
Psychological and Physical Impact on Day-to-day Life, Measured by the Multiple Sclerosis Impact Scale-29 (MSIS-29)
Psychological
|
-5.01 units on a scale
Standard Deviation 15.45
|
-4.74 units on a scale
Standard Deviation 13.45
|
|
Psychological and Physical Impact on Day-to-day Life, Measured by the Multiple Sclerosis Impact Scale-29 (MSIS-29)
Physical
|
-4.61 units on a scale
Standard Deviation 14.37
|
-5.94 units on a scale
Standard Deviation 11.37
|
SECONDARY outcome
Timeframe: One month post-interventionEmotional Distress - Depression will be measured using PROMIS Item Bank v1.0 - Emotional Distress - Depression-Short Form 8a at one month post intervention. Minimum score = 8. Maximum score = 40. A higher score is a worse outcome.
Outcome measures
| Measure |
Spasticity Take Control
n=105 Participants
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.
Spasticity Take Control: Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.
|
Stretching for People With MS: An Illustrated Manual
n=105 Participants
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management.
Stretching for People with MS: An Illustrated Manual: Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management from the manual.
|
|---|---|---|
|
PROMIS Item Bank v1.0 - Emotional Distress - Depression-Short Form 8a
|
-1.61 units on a scale
Standard Deviation 5.98
|
-0.86 units on a scale
Standard Deviation 5.85
|
SECONDARY outcome
Timeframe: One month post-interventionImpact on multiple sclerosis on walking, measured by the Multiple Sclerosis Walking Scale-12 at one month post intervention. Minimum score = 12. Maximum score = 60. A higher score is a worse outcome.
Outcome measures
| Measure |
Spasticity Take Control
n=105 Participants
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.
Spasticity Take Control: Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.
|
Stretching for People With MS: An Illustrated Manual
n=105 Participants
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management.
Stretching for People with MS: An Illustrated Manual: Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management from the manual.
|
|---|---|---|
|
Impact on Multiple Sclerosis on Walking, Measured by the Multiple Sclerosis Walking Scale-12
|
-3.67 units on a scale
Standard Deviation 14.23
|
-4.93 units on a scale
Standard Deviation 16.72
|
SECONDARY outcome
Timeframe: One month post-interventionWalking will be measured using the Timed 25 Foot Walk at one month post intervention, only if visit is in person. No scale - continuous measure. A higher score is a worse outcome.
Outcome measures
| Measure |
Spasticity Take Control
n=105 Participants
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.
Spasticity Take Control: Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.
|
Stretching for People With MS: An Illustrated Manual
n=105 Participants
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management.
Stretching for People with MS: An Illustrated Manual: Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management from the manual.
|
|---|---|---|
|
Walking Measured by the Timed 25 Foot Walk
|
1.18 Seconds
Standard Deviation 7.27
|
0.10 Seconds
Standard Deviation 5.24
|
SECONDARY outcome
Timeframe: One month post-interventionWalking and turning measured by the Timed Up and Go will be measured at one month post intervention, only if visit is in person. No scale - continuous measure. A higher score is a worse outcome.
Outcome measures
| Measure |
Spasticity Take Control
n=105 Participants
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.
Spasticity Take Control: Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.
|
Stretching for People With MS: An Illustrated Manual
n=105 Participants
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management.
Stretching for People with MS: An Illustrated Manual: Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management from the manual.
|
|---|---|---|
|
Walking and Turning Measured by the Timed Up and Go
|
0.68 Seconds
Standard Deviation 5.77
|
0.48 Seconds
Standard Deviation 6.80
|
Adverse Events
Spasticity Take Control
Serious events: 4 serious events
Other events: 3 other events
Deaths: 0 deaths
Stretching for People With MS: An Illustrated Manual
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Spasticity Take Control
n=116 participants at risk
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.
Spasticity Take Control: Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.
|
Stretching for People With MS: An Illustrated Manual
n=115 participants at risk
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management.
Stretching for People with MS: An Illustrated Manual: Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management from the manual.
|
|---|---|---|
|
General disorders
Fall
|
0.86%
1/116 • Number of events 1 • Up to 6 months
|
0.87%
1/115 • Number of events 1 • Up to 6 months
|
|
Nervous system disorders
Hospitalization - MS exacerbation
|
1.7%
2/116 • Number of events 2 • Up to 6 months
|
0.00%
0/115 • Up to 6 months
|
|
Infections and infestations
Hospitalization - Pneumonia
|
0.00%
0/116 • Up to 6 months
|
1.7%
2/115 • Number of events 2 • Up to 6 months
|
|
Cardiac disorders
Heart Attack
|
0.86%
1/116 • Number of events 1 • Up to 6 months
|
0.00%
0/115 • Up to 6 months
|
Other adverse events
| Measure |
Spasticity Take Control
n=116 participants at risk
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.
Spasticity Take Control: Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.
|
Stretching for People With MS: An Illustrated Manual
n=115 participants at risk
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management.
Stretching for People with MS: An Illustrated Manual: Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management from the manual.
|
|---|---|---|
|
General disorders
Plantar Fasciitis
|
0.86%
1/116 • Number of events 1 • Up to 6 months
|
0.00%
0/115 • Up to 6 months
|
|
General disorders
Fall
|
0.86%
1/116 • Number of events 1 • Up to 6 months
|
4.3%
5/115 • Number of events 5 • Up to 6 months
|
|
General disorders
Pain that did not exist previously
|
0.86%
1/116 • Number of events 1 • Up to 6 months
|
1.7%
2/115 • Number of events 2 • Up to 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place