Multiple SclerosisPhase 2NCT02170779
Developing and Testing a Comprehensive MS Spasticity Management Program
A Phase 2 study of Multiple Sclerosis and Spasticity, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Spasticity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Jun 2016
- Phase
- Phase 2
- 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
- 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
Who cannot join
- Other medical or behavioral conditions that would limit participation or completion of the study.
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 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.
Read the 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.
- Conditions
- Multiple Sclerosis, Spasticity
- Being tested
- Spasticity: Take Control, Usual care
- Keywords
- multiple sclerosis, spasticity, stretching, exercise, rehabilitation
- Medical subject headings
- Multiple Sclerosis, Muscle Spasticity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spasticity: Take ControlBehavioural
4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures
Usual careOther
2 visits: baseline followed by usual care of brochure for stretching then outcome measures
| Study group | Role | What they receive |
|---|---|---|
| A Spasticity: Take Control | Experimental | 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures Receives: Behavioral: Spasticity: Take Control |
| B Usual care | Other | 2 visits: baseline and given usual treatment of brochure for stretching, outcome measures Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
MS Walking Scale-12 (MSWS-12)
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.
Measured: at average of 4 months
Secondary outcomes (8)
Timed 25 Foot Walk
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.
Measured: at average of 4 months
Timed up and go Test
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.
Measured: at average of 4 months
2 Minute Walk Test
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.
Measured: at average of 4 months
Modified Fatigue Impact Scale (MFIS)
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.
Measured: at average of 4 months
Multiple Sclerosis Impact Scale (MSIS-29)
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.
Measured: at average of 4 months
Spasticity Measured by the Modified Ashworth Scale
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.
Measured: at average of 4 months
Multiple Sclerosis Spasticity Scale - 88 (MSSS-88)
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.
Measured: at average of 4 months
Beck Depression Inventory II (BDI II)
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.
Measured: at average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startOct 2015
- Primary completionMay 2016
- Study completionJun 2016
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 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, MS, Principal investigator, VA Portland Health Care System, Portland, OR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02170779
- Sponsor's protocol ID
- N1401-P
- Status last verified
- Feb 2017
- First submitted
- 9 Jun 2014
- Last updated
- 28 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing a Comprehensive MS Spasticity Management Program
- ClinicalTrials.gov ID
- NCT02170779
- Acronym / sponsor ID
- N1401-P
- Conditions
- Multiple Sclerosis, Spasticity
- Keywords
- multiple sclerosis, spasticity, stretching, exercise, rehabilitation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Oregon Health and Science University
- Study start
- Oct 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 23 Jun 2014 (estimated)
- Results
- Posted 28 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A Spasticity: Take Control | Experimental | Behavioral: Spasticity: Take Control4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures |
| B Usual care | Other | Other: Usual care2 visits: baseline and given usual treatment of brochure for stretching, outcome measures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Other medical or behavioral conditions that would limit participation or completion of the study.
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 Control4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures | Behavioural | A Spasticity: Take Control |
| Usual care2 visits: baseline followed by usual care of brochure for stretching then outcome measures | Other | B Usual care |
Primary outcome
MS Walking Scale-12 (MSWS-12)
Time frame: 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.
8 secondary outcomes
Timed 25 Foot Walk
Time frame: at average of 4 months
Timed up and go Test
Time frame: at average of 4 months
2 Minute Walk Test
Time frame: at average of 4 months
Modified Fatigue Impact Scale (MFIS)
Time frame: at average of 4 months
Multiple Sclerosis Impact Scale (MSIS-29)
Time frame: at average of 4 months
Spasticity Measured by the Modified Ashworth Scale
Time frame: at average of 4 months
Multiple Sclerosis Spasticity Scale - 88 (MSSS-88)
Time frame: at average of 4 months
Beck Depression Inventory II (BDI II)
Time frame: at average of 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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, 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 Phase 2 study of Multiple Sclerosis and Spasticity, 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 1 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 28 Mar 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Mar 2017). 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?
MS Walking Scale-12 (MSWS-12) (time frame: at average of 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2017.