Multiple SclerosisNCT01796860
Effectiveness of Ankle Foot Orthoses on Gait in Multiple Sclerosis
A study testing AFO 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 a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- AFO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Aug 2013
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals with a primary diagnosis of multiple sclerosis
- Individuals >21 and <60 years old
- Individuals who are able to maintain a walking velocity of 60 cm/sec for at least 2 minutes independently or with the use of a single tip assistive device.
- 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 >/= 35kg/m2
- Individuals with range of motion deficit in the ankle limiting passive range of motion to neutral dorsiflexion
- Individuals that will 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,
- Multiple Sclerosis Neuropsychological Questionnaire (MSNQ) of >22
- Individuals for whom bilateral AFOs are indicated, but have different design
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center, School of Health Professions
Dallas, Texas, 75390
About this study
Official title: The Impact of Ankle Foot Orthosis (AFO) on Gait Recovery in Select Individuals With Multiple Sclerosis (MS)
The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. This orthotic is fabricated to allow ankle range of motion required for normal gait kinematics. Additionally, it controls forward progression of the tibia during the stance phase of gait. This study has three hypotheses 1. Individuals who are fit with the AFO will demonstrate improvements in spatial and temporal gait parameters 2. Individuals who are fit with the AFO will demonstrate improvements in walking endurance, and 3. Individuals who are fit with the AFO will demonstrate improvements in muscle firing profiles/EMG measures.
Read the detailed description
This is a non-randomized, single group (N=15), repeated measures study. The study will take place at the David M. Crowley Research and Rehabilitation Lab in the School of Health Professions at University of Texas Southwestern Medical Center. The outcome measures for the study include: 1. GAITRite System for temporal and spatial parameters, 2. EMG of the anterior tibialis, gastrocnemius, and vastus lateralis muscles, 3. 6 Minute Walk Test (gait endurance) 4. Lower extremity strength, 5. MS Fatigue scale, 6. Observational Gait Analysis - Video tape of over ground walking. This study will be 13 weeks long. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10. They will be 60 minutes in duration. Outcome measures will be assessed at the following times: initial (T1), week 5 (T2), and week 13 (T3). Subjects will be closely monitored throughout the 13 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 study AFO.
- Conditions
- Multiple Sclerosis
- Being tested
- AFO
- Keywords
- Gait, AFO, MS
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFOOther
The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10.
| Study group | Role | What they receive |
|---|---|---|
| AFO | Other | All persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap). Receives: Other: AFO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Step Length From Initial Testing to End of Study
Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor. The mat will record and analyze step length.
Measured: Computerized gait analysis will be done at the time of enrollment and week 13.
Secondary outcomes (1)
Number of Participants With Change in Muscle Activity With Surface Electromyography (EMG) of Key Lower Extremity Muscles From Baseline to Final Testing
Surface electromyography will be done on key muscles in the lower extremity (quadriceps, anterior tibialis, gastrocnemius) during computerized gait assessment. Changes in muscle activity would be things like large changes in amplitude of muscle firing or changes in the timing of muscle firing, for example. These would indicate changes in strength or perhaps motor learning as a result of wearing the ankle foot orthosis.
Measured: Surface EMG will be done at the time of enrollment and week 13.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startSep 2012
- Primary completionAug 2013
- Study completionAug 2013
Why it stopped: Modifications were made to protocol, new IRB pending
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
- 10 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 McCain, DPT, Principal investigator, UTSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01796860
- Sponsor's protocol ID
- MS AFO
- Status last verified
- Aug 2015
- First submitted
- 18 Feb 2013
- Last updated
- 21 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Ankle Foot Orthosis (AFO) on Gait Recovery in Select Individuals With Multiple Sclerosis (MS)
- ClinicalTrials.gov ID
- NCT01796860
- Acronym / sponsor ID
- MS AFO
- Conditions
- Multiple Sclerosis
- Keywords
- Gait, AFO, MS
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Modifications were made to protocol, new IRB pending
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 22 Feb 2013 (estimated)
- Results
- Posted 3 Aug 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 a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. This orthotic is fabricated to allow ankle range of motion required for normal gait kinematics. Additionally, it controls forward progression of the tibia during the stance phase of gait. This study has three hypotheses 1. Individuals who are fit with the AFO will demonstrate improvements in spatial and temporal gait parameters 2. Individuals who are fit with the AFO will demonstrate improvements in walking endurance, and 3. Individuals who are fit with the AFO will demonstrate improvements in muscle firing profiles/EMG measures.
Detailed description
This is a non-randomized, single group (N=15), repeated measures study. The study will take place at the David M. Crowley Research and Rehabilitation Lab in the School of Health Professions at University of Texas Southwestern Medical Center. The outcome measures for the study include: 1. GAITRite System for temporal and spatial parameters, 2. EMG of the anterior tibialis, gastrocnemius, and vastus lateralis muscles, 3. 6 Minute Walk Test (gait endurance) 4. Lower extremity strength, 5. MS Fatigue scale, 6. Observational Gait Analysis - Video tape of over ground walking. This study will be 13 weeks long. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10. They will be 60 minutes in duration. Outcome measures will be assessed at the following times: initial (T1), week 5 (T2), and week 13 (T3). Subjects will be closely monitored throughout the 13 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 study AFO.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AFO | Other | Other: AFOAll persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap). |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Individuals with a primary diagnosis of multiple sclerosis
- Individuals >21 and <60 years old
- Individuals who are able to maintain a walking velocity of 60 cm/sec for at least 2 minutes independently or with the use of a single tip assistive device.
- Current or past history of single or bilateral AFO use, including neuroprostheses
- Evidence of weakness in plantarflexors
Key exclusion criteria (8 listed)
- The presence of co-morbidities (neuromuscular or musculoskeletal) that would negatively impact gait training
- Individuals with BMI with >/= 35kg/m2
- Individuals with range of motion deficit in the ankle limiting passive range of motion to neutral dorsiflexion
- Individuals that will 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 |
|---|---|---|
| AFOThe purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10. | Other | AFO |
Primary outcome
Change in Step Length From Initial Testing to End of Study
Time frame: Computerized gait analysis will be done at the time of enrollment and week 13.
Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor. The mat will record and analyze step length.
1 secondary outcome
Number of Participants With Change in Muscle Activity With Surface Electromyography (EMG) of Key Lower Extremity Muscles From Baseline to Final Testing
Time frame: Surface EMG will be done at the time of enrollment and week 13.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2015.
- 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 McCain, DPT principal investigator
UTSW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AFO 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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 21 Aug 2015. 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 3 Aug 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 Step Length From Initial Testing to End of Study (time frame: Computerized gait analysis will be done at the time of enrollment and week 13.). 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 21 Aug 2015.