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Modifications were made to protocol, new IRB pending
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AFO | Other | All persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AFO | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Computerized gait analysis will be done at the time of enrollment and week 13. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Walking Endurance Using a 6-Minute Walk Test (6MWT) From Initial Testing to Final Testing | Each participant will be asked to walk at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices as necessary. | 6MWT will be done at the time of enrollment and week 13. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen McCain, DPT | UTSW | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center, School of Health Professions | Dallas | Texas | 75390 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ankle Foot Orthosis Group | All persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap). AFO: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ankle Foot Orthosis Group | All persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap). AFO: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | measure of length (cm) | Computerized gait analysis will be done at the time of enrollment and week 13. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ankle Foot Orthosis Group | All persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap). AFO: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen J McCain, PT, DPT, NCS, Principal Investigator | University of Texas Southwestern Medical Center | 214-648-1559 | karen.mccain@utsouthwestern.edu |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Surface EMG will be done at the time of enrollment and week 13. |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | 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. | Posted | Number | participants | Surface EMG will be done at the time of enrollment and week 13. |
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| Other Pre-specified | Change in Walking Endurance Using a 6-Minute Walk Test (6MWT) From Initial Testing to Final Testing | Each participant will be asked to walk at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices as necessary. | Posted | Mean | Standard Deviation | meters | 6MWT will be done at the time of enrollment and week 13. |
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| 0 |
| 7 |
| 0 |
| 7 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |