Multiple Sclerosis
Conditions
Keywords
multiple sclerosis, gait, ankle foot orthosis (AFO)
Brief 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. 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.
Interventions
DEVICEAnkle foot orthosis
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.
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
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Walking Distance During 6-Minute Walk Test | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Impact of MS on Fatigue Using the 12-Item Walk Scale | Assessed at visit 2 (week 1) and week 24 | 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. |
| Change in Step Length Using the GAITRite Computerized Gait Analysis System | Assessed at visit 2 (week 1) and week 24 | Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor. |
| Number of Persons With Change in Muscle Activity Using Surface Electromyography (EMG) | Assessed at visit 2 (week 1) and week 24 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Application of Ankle Foot Orthosis persons in this group were fitted with bilateral ankle foot orthoses | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Application of Ankle Foot Orthosis |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age, Continuous | 48 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 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 | 1 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 | 0 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
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.
Time frame: Assessed at visit 2 (week 1) and week 24
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Application of Ankle Foot Orthosis | Change in Walking Distance During 6-Minute Walk Test | 222 feet |
Secondary
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.
Time frame: Assessed at visit 2 (week 1) and week 24
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Application of Ankle Foot Orthosis | Change in Impact of MS on Fatigue Using the 12-Item Walk Scale | 1 difference of sum of score |
Secondary
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.
Time frame: Assessed at visit 2 (week 1) and week 24
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Application of Ankle Foot Orthosis | Change in Step Length Using the GAITRite Computerized Gait Analysis System | 3.3 cm |
Secondary
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.
Time frame: Assessed at visit 2 (week 1) and week 24
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Application of Ankle Foot Orthosis | Number of Persons With Change in Muscle Activity Using Surface Electromyography (EMG) | 1 persons |