Multiple SclerosisSTCNCT03166930
Evaluation of a Spasticity Management Program for People With Multiple Sclerosis
A study testing Stretching for People with MS: An Illustrated Manual in people with Multiple Sclerosis, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Stretching for People with MS: An Illustrated Manual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97239
About this study
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.
Read the detailed description
Now online since COVID-19
- Conditions
- Multiple Sclerosis
- Being tested
- Spasticity Take Control, Stretching for People with MS: An Illustrated Manual
- Keywords
- Muscle Spasticity, Muscle Stretching Exercises
- Medical subject headings
- Multiple Sclerosis, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spasticity Take ControlBehavioural
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 ManualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Spasticity Take Control |
| 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. Receives: Behavioral: Stretching for People with MS: An Illustrated Manual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Six months post-intervention
Secondary outcomes (8)
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.
Measured: One month post-intervention
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start1 Jan 2018
- Primary completion30 Jul 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Oregon Health and Science University
- Responsible party
- Sponsor
- Investigators
- Lucinda L. Hugos, PT MS, Principal investigator, VA Portland Health Care System, Portland, OR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166930
- Sponsor's protocol ID
- B2507-R
- Other IDs
- I01RX002507
- Acronym
- STC
- Status last verified
- Mar 2026
- First submitted
- 19 May 2017
- Last updated
- 11 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33028236
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Spasticity Management Program for People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03166930
- Acronym / sponsor ID
- STC / B2507-R
- Conditions
- Multiple Sclerosis
- Keywords
- Muscle Spasticity, Muscle Stretching Exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Oregon Health and Science University
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 25 May 2017 (actual)
- Results
- Posted 11 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Spasticity Take Control | Experimental | Behavioral: Spasticity Take ControlParticipants 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 | Behavioral: Stretching for People with MS: An Illustrated ManualParticipants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spasticity Take ControlParticipants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management. | Behavioural | Spasticity Take Control |
| Stretching for People with MS: An Illustrated ManualParticipants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management from the manual. | Behavioural | Stretching for People with MS: An Illustrated Manual |
Primary outcome
Impact of Spasticity, Measured by the Multiple Sclerosis Spasticity Scale-88
Time frame: 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.
Impact of Spasticity, Measured by the Multiple Sclerosis Spasticity Scale-88
Time frame: Six months post-intervention
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.
8 secondary outcomes
Severity of Spasticity, Measured by the Numeric Rating Scale for Spasticity
Time frame: One month post-intervention
Fatigue, Measured by the Modified Fatigue Impact Scale
Time frame: One month post-intervention
Sleep Quality and Quantity, Measured by the Pittsburgh Sleep Quality Index
Time frame: One month post-intervention
Psychological and Physical Impact on Day-to-day Life, Measured by the Multiple Sclerosis Impact Scale-29 (MSIS-29)
Time frame: One month post-intervention
PROMIS Item Bank v1.0 - Emotional Distress - Depression-Short Form 8a
Time frame: One month post-intervention
Impact on Multiple Sclerosis on Walking, Measured by the Multiple Sclerosis Walking Scale-12
Time frame: One month post-intervention
Walking Measured by the Timed 25 Foot Walk
Time frame: One month post-intervention
Walking and Turning Measured by the Timed Up and Go
Time frame: One month post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33028236Hugos 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucinda L. Hugos, PT MS principal investigator
VA Portland Health Care System, Portland, OR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stretching for People with MS: An Illustrated Manual in people with Multiple Sclerosis, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Spasticity, Measured by the Multiple Sclerosis Spasticity Scale-88 (time frame: One month post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03166930, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.