Multiple Sclerosis
Conditions
Keywords
Muscle Spasticity, Muscle Stretching Exercises
Brief summary
This study will examine the impacts of two different methods of managing MS-related spasticity of the lower limbs. Both interventions will be presented via video teleconference in group classes consisting of exercises to reduce spasticity.
Detailed description
Now online since COVID-19
Interventions
BEHAVIORALSpasticity 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.
BEHAVIORALStretching 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.
Sponsors
VA Office of Research and Development
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Participants will be randomized to receive one of two exercise programs. Participants will not be masked regarding which group they are in, but they will not be told which group is considered standard of care and which is the intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A diagnosis of definite MS by 2010 updated McDonald Criteria * Age 18 or older * Able to walk 25 feet with any assistive devices (Patient Determined Disease Steps 0-6) * Fluent in written and spoken English, as materials are not validated in languages other than English. * Presence of self-reported lower extremity spasticity that is interfering with daily activities or sleep, using the this definition: Have spasticity in your legs with unusual tightening of muscles that feels like leg stiffness, jumping of the legs, a repetitive bouncing of the foot, muscle cramping in the legs, or the legs going out tight and straight or drawing up. * All women that meet the above criteria * Only Veteran men that meet the above criteria
Exclusion criteria
* Any uncontrolled medical or mental condition that would limit participation or completion of the study * Any self-reported musculoskeletal or neurological condition other than MS that is known to cause spasticity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of Spasticity, Measured by the Multiple Sclerosis Spasticity Scale-88 | One month post-intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Spasticity, Measured by the Numeric Rating Scale for Spasticity | One month post-intervention | Severity 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. |
| Fatigue, Measured by the Modified Fatigue Impact Scale | One month post-intervention | Fatigue 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. |
| Sleep Quality and Quantity, Measured by the Pittsburgh Sleep Quality Index | One month post-intervention | Sleep 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. |
| Psychological and Physical Impact on Day-to-day Life, Measured by the Multiple Sclerosis Impact Scale-29 (MSIS-29) | One month post-intervention | Impact 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. |
| PROMIS Item Bank v1.0 - Emotional Distress - Depression-Short Form 8a | One month post-intervention | Emotional 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. |
| Impact on Multiple Sclerosis on Walking, Measured by the Multiple Sclerosis Walking Scale-12 | One month post-intervention | Impact 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. |
| Walking Measured by the Timed 25 Foot Walk | One month post-intervention | Walking 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. |
| Walking and Turning Measured by the Timed Up and Go | One month post-intervention | Walking 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLucinda L. Hugos, PT MS
VA Portland Health Care System, Portland, OR
Participant flow
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 54.4 Years STANDARD_DEVIATION 11.6 |
| Multiple Sclerosis Spasticity Scale - 88 | 189.05 units on a scale STANDARD_DEVIATION 48.64 |
| Race/Ethnicity, Customized Hispanic or Latino | 8 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 112 Participants |
| Race/Ethnicity, Customized Race Unknown | 15 Participants |
| Race/Ethnicity, Customized White | 100 Participants |
| Region of Enrollment United States | 116 Participants |
| Sex: Female, Male Female | 99 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 116 | 0 / 115 |
| other Total, other adverse events | 3 / 116 | 7 / 115 |
| serious Total, serious adverse events | 4 / 116 | 3 / 115 |
Outcome results
None listed