Multiple SclerosisNCT01947582
The Effects of Ankle Foot Orthoses (AFOs) on Mobility in Persons With Multiple Sclerosis (MS)
A study testing Ankle foot orthosis in people with Multiple Sclerosis, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to investigate the impact of ankle foot orthoses (AFOs) on the spatial and temporal gait parameters, electromyography (EMG), walking endurance, and quality of life in select individuals living with MS. The hypotheses of the study are: 1. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Ankle foot orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Dec 2014
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals with a primary diagnosis of multiple sclerosis
- Individuals who are able to maintain a walking velocity of 30 cm/sec for at least 2 minutes independently or with the use of a single tip assistive device.
- Could have current or past history of single or bilateral AFO use, including neuroprostheses
- Evidence of weakness in plantarflexors
Who cannot join
- The presence of co-morbidities (neuromuscular or musculoskeletal) that would negatively impact gait training
- Individuals with BMI with >/= 40kg/m2
- Individuals with range of motion deficit in the ankle limiting passive range of motion to neutral dorsiflexion
- Individuals that plan to begin the use of Ampyra during the course of the study
- Individuals for whom the cost of an orthosis would represent a financial burden
- Individuals who are receiving concurrent physical therapy services elsewhere
- MSNQ of >22
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Southwestern Medical Center School of Health Professions
Dallas, Texas, 75223
About this study
The purpose of this study is to investigate the impact of ankle foot orthoses (AFOs) on the spatial and temporal gait parameters, electromyography (EMG), walking endurance, and quality of life in select individuals living with MS. The hypotheses of the study are: 1. Individuals who are fit with an AFO will demonstrate improvements in spatial and temporal gait parameters 2. Individuals who are fit with an AFO will demonstrate improvements in walking endurance. 3. Individuals who are fit with an AFO will demonstrate improvements in muscle firing profiles/EMG measures. 4. Individuals who are fit with an AFO will demonstrate improvements in quality of life.
Read the detailed description
This is a non-randomized, single group (N=15), repeated measures study. The outcome measure for the study include: 1. GAITRite System for step length, 2. EMG of the anterior tibialis, gastrocnemius, soleus, and vastus lateralis muscles, 3. 6 Minute Walk Test (gait endurance) 4. 12-Item MS Walking Scale (Quality of Life assessment). This study will be 24 weeks long. Over the 24-week period, the subject will participate in 14 gait training sessions which will be at weeks 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 17, 20 and 23. The treatments will be 45-60 minutes in duration. Outcome measures (all or part) will be assessed at the following times: initial (T1), week 5 (T2), week 13 (T3), and week 24 (T4). Subjects will be closely monitored throughout the 24 week study and will be un-enrolled by self-request or the following medical reasons: 1. Acute exacerbation of MS symptoms, 2. New diagnosis with direct consequences affecting gait training, 3. Inability to tolerate the AFO.
- Conditions
- Multiple Sclerosis
- Being tested
- Ankle foot orthosis
- Keywords
- multiple sclerosis, gait, ankle foot orthosis (AFO)
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle foot orthosisDevice
The ankle foot orthoses (AFOs) that will be used are designed to provide assistance with anterior tibial advancement during stance and dorsi flexion assistance during swing. The device(s) are polypropylene and are custom-fabricated.
| Study group | Role | What they receive |
|---|---|---|
| Application of ankle foot orthosis | Other | All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings. Receives: Device: Ankle foot orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Walking Distance During 6-Minute Walk Test
Each participant walks at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices if necessary. They will be asked to rate their level of exertion upon completion of walking on the rate of perceived exertion scale.
Measured: Assessed at visit 2 (week 1) and week 24
Secondary outcomes (3)
Change in Impact of MS on Fatigue Using the 12-Item Walk Scale
The 12-Item Walk Scale is a paper and pencil test that asks persons with MS to rate their level of fatigue when doing functional tasks. The maximum possible score is 60 points and the lowest possible score is 12. Higher scores indicate a greater impact on walking than lower scores.
Measured: Assessed at visit 2 (week 1) and week 24
Change in Step Length Using the GAITRite Computerized Gait Analysis System
Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor.
Measured: Assessed at visit 2 (week 1) and week 24
Number of Persons With Change in Muscle Activity Using Surface Electromyography (EMG)
Surface EMG is done on key muscles in the lower extremity (quadriceps, anterior tibialis, gastrocnemius, soleus) during computerized gait assessment. Changes in amplitude of muscle activity or timing of muscle activity would indicate, for example, increases in strength or changes in timing of muscles which might indicate motor learning as a result of wearing the ankle foot orthosis.
Measured: Assessed at visit 2 (week 1) and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2014
- Study completionDec 2014
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 University of Texas Southwestern Medical CenterThe 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen McCain, University of Texas Southwestern Medical Center
- Investigators
- Karen J McCain, PT, DPT, NCS, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947582
- Sponsor's protocol ID
- MS Bracing
- Status last verified
- Feb 2016
- First submitted
- 17 Sep 2013
- Last updated
- 7 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ankle Foot Orthoses (AFOs) on Mobility in Persons With Multiple Sclerosis (MS)
- ClinicalTrials.gov ID
- NCT01947582
- Acronym / sponsor ID
- MS Bracing
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, gait, ankle foot orthosis (AFO)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Sep 2013 (estimated)
- Results
- Posted 1 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the impact of ankle foot orthoses (AFOs) on the spatial and temporal gait parameters, electromyography (EMG), walking endurance, and quality of life in select individuals living with MS. The hypotheses of the study are: 1. Individuals who are fit with an AFO will demonstrate improvements in spatial and temporal gait parameters 2. Individuals who are fit with an AFO will demonstrate improvements in walking endurance. 3. Individuals who are fit with an AFO will demonstrate improvements in muscle firing profiles/EMG measures. 4. Individuals who are fit with an AFO will demonstrate improvements in quality of life.
Detailed description
This is a non-randomized, single group (N=15), repeated measures study. The outcome measure for the study include: 1. GAITRite System for step length, 2. EMG of the anterior tibialis, gastrocnemius, soleus, and vastus lateralis muscles, 3. 6 Minute Walk Test (gait endurance) 4. 12-Item MS Walking Scale (Quality of Life assessment). This study will be 24 weeks long. Over the 24-week period, the subject will participate in 14 gait training sessions which will be at weeks 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 17, 20 and 23. The treatments will be 45-60 minutes in duration. Outcome measures (all or part) will be assessed at the following times: initial (T1), week 5 (T2), week 13 (T3), and week 24 (T4). Subjects will be closely monitored throughout the 24 week study and will be un-enrolled by self-request or the following medical reasons: 1. Acute exacerbation of MS symptoms, 2. New diagnosis with direct consequences affecting gait training, 3. Inability to tolerate the AFO.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Application of ankle foot orthosis | Other | Device: Ankle foot orthosisAll participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Individuals with a primary diagnosis of multiple sclerosis
- Individuals who are able to maintain a walking velocity of 30 cm/sec for at least 2 minutes independently or with the use of a single tip assistive device.
- Could have current or past history of single or bilateral AFO use, including neuroprostheses
- Evidence of weakness in plantarflexors
Key exclusion criteria (7 listed)
- The presence of co-morbidities (neuromuscular or musculoskeletal) that would negatively impact gait training
- Individuals with BMI with >/= 40kg/m2
- Individuals with range of motion deficit in the ankle limiting passive range of motion to neutral dorsiflexion
- Individuals that plan to begin the use of Ampyra during the course of the study
- Individuals for whom the cost of an orthosis would represent a financial burden
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 |
|---|---|---|
| Ankle foot orthosisThe ankle foot orthoses (AFOs) that will be used are designed to provide assistance with anterior tibial advancement during stance and dorsi flexion assistance during swing. The device(s) are polypropylene and are custom-fabricated. | Device | Application of ankle foot orthosis |
Primary outcome
Change in Walking Distance During 6-Minute Walk Test
Time frame: Assessed at visit 2 (week 1) and week 24
Each participant walks at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices if necessary. They will be asked to rate their level of exertion upon completion of walking on the rate of perceived exertion scale.
3 secondary outcomes
Change in Impact of MS on Fatigue Using the 12-Item Walk Scale
Time frame: Assessed at visit 2 (week 1) and week 24
Change in Step Length Using the GAITRite Computerized Gait Analysis System
Time frame: Assessed at visit 2 (week 1) and week 24
Number of Persons With Change in Muscle Activity Using Surface Electromyography (EMG)
Time frame: Assessed at visit 2 (week 1) and week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Karen J McCain, PT, DPT, NCS principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankle foot orthosis in people with Multiple Sclerosis, run by University of Texas Southwestern Medical Center 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 4 inclusion and 7 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 7 Mar 2016. 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 1 Jun 2015). 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?
Change in Walking Distance During 6-Minute Walk Test (time frame: Assessed at visit 2 (week 1) and week 24). 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 7 Mar 2016.