Multiple SclerosisNCT03175133
Strength Training to Improve Gait in People With Multiple Sclerosis
A study testing Strength exercise in people with Multiple Sclerosis, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study will pilot a strengthening intervention targeted to muscles found to be important to gait in people with multiple sclerosis (MS). Previous studies that have tried to strengthen leg and trunk muscles in people with MS have failed to improve walking ability consistently. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Strength exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2017to 8 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People with MS,
- Age 18-65,
- A confirmed diagnosis of MS, and
- Are ambulatory for 100m without an assistive device (EDDS 0-5.5), and
- Have a gait speed measured by time to walk the 25-foot walk test of at least five seconds.
Who cannot join
- Subjects are not ambulatory,
- Subjects rely on a wheelchair,
- Subjects cannot ambulate 100m (EDDS 6 or greater) without use of assistive devices, braces, or orthotics,
- Walk the T25FW in less than five seconds,
- Have lower extremity spasticity of 2 or greater on the Modified Ashworth Scale (MAS),
- Have pain or other conditions that limit ambulation or ability to test muscle strength,
Show all 12Show fewer
- Cannot give consent,
- Cannot follow simple directions,
- Have had an exacerbation in the past month,
- Have had changes to their drug therapy in the last month,
- Have other neurologic diagnoses, or
- Are currently undergoing physical therapy for strength training.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
Official title: Targeted Strength Training to Improve Gait in People With Multiple Sclerosis: a Feasibility Study
This study will pilot a strengthening intervention targeted to muscles found to be important to gait in people with multiple sclerosis (MS). Previous studies that have tried to strengthen leg and trunk muscles in people with MS have failed to improve walking ability consistently. The investigators think that is because strengthening exercises were not targeted to the correct muscle groups. For this study the investigators propose targeting muscle groups that they have found to be strong contributors to walking in a prior study. This is the first study to target these muscles, so the investigators propose doing a small trial to first evaluate the feasibility of the strength program and the outcomes. The investigators will measure strength and walking measures twice before and once after an 8-week strengthening intervention in a single group of 10 people with MS who are able to walk independently. The results of this study will help inform future, larger trials that could change the way strength training is conducted in people with MS.
- Conditions
- Multiple Sclerosis
- Being tested
- Strength exercise
- Keywords
- rehabilitation, physical therapy
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength exerciseOther
Strengthening exercises performed with physical therapist.
| Study group | Role | What they receive |
|---|---|---|
| Strength training | Experimental | Strength exercises for ankle PF, hip abduction, and trunk muscles. Exercises will be done in three standard positions of supine, sidelying, prone, seated, and standing. Exercises during the initial 4 weeks will be completed 2x week with supervision of a physical therapist and 2x week at home, for a total of 4x week. For the final 4 weeks of the intervention will be completed 1x week with supervision and 3x week at home. Receives: Other: Strength exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Muscle Strength
Muscle strength measured by hand-held dynamometry (HHD) and clinical strength tests
Measured: Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up)
Change in Timed 25 Foot Walk (T25FW)
Gait speed over a 25 foot distance
Measured: Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up)
Secondary outcomes (4)
Change in 6-Minute Walk Test
Gait endurance
Measured: Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up)
Change in Dynamic Gait Index
Balance during gait and other functional activities
Measured: Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up)
Change in Multiple Sclerosis Walking Scale-12
Self-report measure of limitations in walking related activities
Measured: Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up)
Change in Patient Specific Functional Scale
Self reported measure of self-selected limitations in participation
Measured: Week 0 (Baseline 1); Week 10 (Follow-Up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start23 May 2017
- Primary completion8 Nov 2017
- Study completion8 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 University of Colorado, DenverThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margaret Schenkman, PT, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175133
- Sponsor's protocol ID
- 16-2610
- Status last verified
- Apr 2018
- First submitted
- 23 May 2017
- Last updated
- 13 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Manago MM, Hebert JR, Schenkman M. Psychometric Properties of a Clinical Strength Assessment Protocol in People with Multiple Sclerosis. Int J MS Care. 2017 Sep-Oct;19(5):253-262. doi: 10.7224/1537-2073.2016-078.
PubMed 29070966
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Strength Training to Improve Gait in People With Multiple Sclerosis: a Feasibility Study
- ClinicalTrials.gov ID
- NCT03175133
- Acronym / sponsor ID
- 16-2610
- Conditions
- Multiple Sclerosis
- Keywords
- rehabilitation, physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 23 May 2017 (actual)
- Primary completion
- 8 Nov 2017 (actual)
- Study completion
- 8 Nov 2017 (actual)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
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 pilot a strengthening intervention targeted to muscles found to be important to gait in people with multiple sclerosis (MS). Previous studies that have tried to strengthen leg and trunk muscles in people with MS have failed to improve walking ability consistently. The investigators think that is because strengthening exercises were not targeted to the correct muscle groups. For this study the investigators propose targeting muscle groups that they have found to be strong contributors to walking in a prior study. This is the first study to target these muscles, so the investigators propose doing a small trial to first evaluate the feasibility of the strength program and the outcomes. The investigators will measure strength and walking measures twice before and once after an 8-week strengthening intervention in a single group of 10 people with MS who are able to walk independently. The results of this study will help inform future, larger trials that could change the way strength training is conducted in people with MS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Strength training | Experimental | Other: Strength exerciseStrength exercises for ankle PF, hip abduction, and trunk muscles. Exercises will be done in three standard positions of supine, sidelying, prone, seated, and standing. Exercises during the initial 4 weeks will be completed 2x week with supervision of a physical therapist and 2x week at home, for a total of 4x week. For the final 4 weeks of the intervention will be completed 1x week with supervision and 3x week at home. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- People with MS,
- Age 18-65,
- A confirmed diagnosis of MS, and
- Are ambulatory for 100m without an assistive device (EDDS 0-5.5), and
- Have a gait speed measured by time to walk the 25-foot walk test of at least five seconds.
Key exclusion criteria (12 listed)
- Subjects are not ambulatory,
- Subjects rely on a wheelchair,
- Subjects cannot ambulate 100m (EDDS 6 or greater) without use of assistive devices, braces, or orthotics,
- Walk the T25FW in less than five seconds,
- Have lower extremity spasticity of 2 or greater on the Modified Ashworth Scale (MAS),
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 |
|---|---|---|
| Strength exerciseStrengthening exercises performed with physical therapist. | Other | Strength training |
Primary outcome
Change in Muscle Strength
Time frame: Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up)
Muscle strength measured by hand-held dynamometry (HHD) and clinical strength tests
Change in Timed 25 Foot Walk (T25FW)
Time frame: Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up)
Gait speed over a 25 foot distance
4 secondary outcomes
Change in 6-Minute Walk Test
Time frame: Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up)
Change in Dynamic Gait Index
Time frame: Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up)
Change in Multiple Sclerosis Walking Scale-12
Time frame: Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up)
Change in Patient Specific Functional Scale
Time frame: Week 0 (Baseline 1); Week 10 (Follow-Up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2018.
- Background: PubMed 29070966Manago MM, Hebert JR, Schenkman M. Psychometric Properties of a Clinical Strength Assessment Protocol in People with Multiple Sclerosis. Int J MS Care. 2017 Sep-Oct;19(5):253-262. doi: 10.7224/1537-2073.2016-078.
- 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.
Margaret Schenkman, PT, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength exercise in people with Multiple Sclerosis, run by University of Colorado, Denver 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 5 inclusion and 12 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 13 Apr 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Muscle Strength (time frame: Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up)). 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 NCT03175133, 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 13 Apr 2018.