Multiple Sclerosis
Conditions
Keywords
Gait, AFO, MS
Brief 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. 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.
Interventions
OTHERAFO
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.
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Step Length From Initial Testing to End of Study | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Change in Muscle Activity With Surface Electromyography (EMG) of Key Lower Extremity Muscles From Baseline to Final Testing | Surface EMG will be done at the time of enrollment and week 13. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Walking Endurance Using a 6-Minute Walk Test (6MWT) From Initial Testing to Final Testing | 6MWT will be done at the time of enrollment and week 13. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Ankle Foot Orthosis Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age, Continuous | 49.5 years STANDARD_DEVIATION 5.83 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
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.
Time frame: Computerized gait analysis will be done at the time of enrollment and week 13.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ankle Foot Orthosis Group | Change in Step Length From Initial Testing to End of Study | 6.47 measure of length (cm) | Standard Deviation 3.26 |
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.
Time frame: Surface EMG will be done at the time of enrollment and week 13.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ankle Foot Orthosis Group | Number of Participants With Change in Muscle Activity With Surface Electromyography (EMG) of Key Lower Extremity Muscles From Baseline to Final Testing | 0 participants |
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.
Time frame: 6MWT will be done at the time of enrollment and week 13.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ankle Foot Orthosis Group | Change in Walking Endurance Using a 6-Minute Walk Test (6MWT) From Initial Testing to Final Testing | 44.28 meters | Standard Deviation 77.12 |