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| ID | Type | Description | Link |
|---|---|---|---|
| I01RX002507 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Oregon Health and Science University | OTHER |
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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.
Now online since COVID-19
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spasticity Take Control | Experimental | 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 | Active Comparator | Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spasticity Take Control | Behavioral | Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management. |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of Spasticity, Measured by the Multiple Sclerosis Spasticity Scale-88 | 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. | One month post-intervention |
| Impact of Spasticity, Measured by the Multiple Sclerosis Spasticity Scale-88 | Impact 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. | Six months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Spasticity, Measured by the Numeric Rating Scale for Spasticity | 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. | One month post-intervention |
| Fatigue, Measured by the Modified Fatigue Impact Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lucinda L. Hugos, PT MS | VA Portland Health Care System, Portland, OR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Portland Health Care System, Portland, OR | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33028236 | Derived | Hugos CL, Cameron MH. MS Spasticity: Take Control (STC) for ambulatory adults: protocol for a randomized controlled trial. BMC Neurol. 2020 Oct 7;20(1):368. doi: 10.1186/s12883-020-01902-1. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Impact of Spasticity, Measured by the Multiple Sclerosis Spasticity Scale-88 | 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. | Posted | Mean | Standard Deviation | units on a scale | One month post-intervention |
|
Up to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Plantar Fasciitis | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cinda Hugos | VAPORHCS | 5038050269 | 2cinda@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 3, 2021 | Feb 10, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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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.
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| Stretching for People with MS: An Illustrated Manual | Behavioral | 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 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. |
| One month post-intervention |
| Sleep Quality and Quantity, Measured by the Pittsburgh Sleep Quality Index | 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. | One month post-intervention |
| Psychological and Physical Impact on Day-to-day Life, Measured by the Multiple Sclerosis Impact Scale-29 (MSIS-29) | 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. | One month post-intervention |
| PROMIS Item Bank v1.0 - Emotional Distress - Depression-Short Form 8a | 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. | One month post-intervention |
| Impact on Multiple Sclerosis on Walking, Measured by the Multiple Sclerosis Walking Scale-12 | 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. | One month post-intervention |
| Walking Measured by the Timed 25 Foot Walk | 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. | One month post-intervention |
| Walking and Turning Measured by the Timed Up and Go | 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. | One month post-intervention |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Multiple Sclerosis Spasticity Scale - 88 | Minimum score = 88. Maximum score = 352 | Includes only participants that provided an outcome measurement at 1 and/or 6 months | Mean | Standard Deviation | units on a scale |
|
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. |
|
|
| Primary | Impact of Spasticity, Measured by the Multiple Sclerosis Spasticity Scale-88 | Impact 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. | Posted | Mean | Standard Deviation | units on a scale | Six months post-intervention |
|
|
|
| Secondary | Severity of Spasticity, Measured by the Numeric Rating Scale for Spasticity | 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. | Posted | Mean | Standard Deviation | units on a scale | One month post-intervention |
|
|
|
| Secondary | Fatigue, Measured by the Modified Fatigue Impact Scale | 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. | Posted | Mean | Standard Deviation | units on a scale | One month post-intervention |
|
|
|
| Secondary | Sleep Quality and Quantity, Measured by the Pittsburgh Sleep Quality Index | 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. | Posted | Mean | Standard Deviation | units on a scale | One month post-intervention |
|
|
|
| Secondary | Psychological and Physical Impact on Day-to-day Life, Measured by the Multiple Sclerosis Impact Scale-29 (MSIS-29) | 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. | Posted | Mean | Standard Deviation | units on a scale | One month post-intervention |
|
|
|
| Secondary | PROMIS Item Bank v1.0 - Emotional Distress - Depression-Short Form 8a | 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. | Posted | Mean | Standard Deviation | units on a scale | One month post-intervention |
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| Secondary | Impact on Multiple Sclerosis on Walking, Measured by the Multiple Sclerosis Walking Scale-12 | 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. | Posted | Mean | Standard Deviation | units on a scale | One month post-intervention |
|
|
|
| Secondary | Walking Measured by the Timed 25 Foot Walk | 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. | Posted | Mean | Standard Deviation | Seconds | One month post-intervention |
|
|
|
| Secondary | Walking and Turning Measured by the Timed Up and Go | 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. | Posted | Mean | Standard Deviation | Seconds | One month post-intervention |
|
|
|
| 0 |
| 116 |
| 4 |
| 116 |
| 3 |
| 116 |
| EG001 | 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. | 0 | 115 | 3 | 115 | 7 | 115 |
| Hospitalization - MS exacerbation | Nervous system disorders | Systematic Assessment |
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| Hospitalization - Pneumonia | Infections and infestations | Systematic Assessment |
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| Heart Attack | Cardiac disorders | Systematic Assessment |
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| Fall | General disorders | Systematic Assessment |
|
| Pain that did not exist previously | General disorders | Systematic Assessment |
|
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |