Ankle Foot Orthosis (AFO), Lower Limb Injury, Lower Limb Trauma
Conditions
Keywords
Ankle foot orthosis (AFO), activity monitor, lower limb injury, gait, activities of daily living, lower extremity trauma
Brief summary
The purpose of the study is to test different categories of ankle foot orthoses (AFOs) with patients who have had lower limb salvage, reconstruction or other problems impacting limb function.
Detailed description
The purpose of the study is to test different categories of ankle foot orthoses (AFOs) with patients who have had lower limb salvage, reconstruction or other problems impacting limb function. Some lower limb AFO users will decide later to amputate the affected limb to escape pain and repeated surgery requiring them to use a prosthesis instead. Benefits may include reduced pain and more function from a prosthesis. This research will allow physicians, physical therapists, orthotists, and researchers to determine what modifications can be made to AFOs to make them more comfortable and usable. Over the course of a year, subjects will test both AFO types; a conventional (standard) AFO and an advanced (energy storing and return) AFO, in a battery of physical tests, community use, and surveys to gain a better understanding of the pros and cons of each. Subjects will be recruited to participate in research for approximately 18 months. During the first six weeks (up to three weeks on each type of AFO), subjects will be provided with an AFO and given training on how to correctly use and maintain it, to ensure optimal use. Over the following 12 months, there will be monthly assessments including questionnaires, activity monitor uploads, device failures, and interviews to gather information on the subject's experience with AFO use.
Interventions
DEVICEAdvanced Ankle Foot Orthosis (AFO)
Subjects will be initially fit with the AFO category they do not use on a daily basis to ensure they have both AFO categories for the study. These "advanced" AFOs have been developed to offer energy-storing-and-returning (ESR) properties to the user. Advanced Ankle Foot Orthoses include designs that are widely believed to return stored energy in late stance. These designs are laminated and may include posterior struts.
DEVICEConventional Ankle Foot Orthosis (AFO)
Subjects will be initially fit with the AFO category they do not use on a daily basis to ensure they have both AFO categories for the study. Conventional Ankle Foot Orthoses have been more commonly used in past decades. AFOs within the conventional category generally include designs that will not return stored energy in late stance. These designs may vary in material construction and componentry. For instance, mechanical joints can be incorporated but do not have to be for inclusion in this group. AFOs in this category may be thermoplastic materials or thermoset laminate. The devices may be off-the-shelf or custom molded to the patient.
Sponsors
University of South Florida
Tampa VA Healthcare System
VA New York Harbor Healthcare System
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Statistician
Intervention model description
Randomized cross over with long term observational follow up. Conventional AFO and Advanced AFO. Assess long-term (1 year) patient-reported outcomes of advanced and conventional AFO use in individuals with lower extremity trauma.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Lower extremity injury of any etiology requiring current use of an AFO * Age 18-80 years * 100-275 lbs * Greater than 1 month of AFO experience * Use of an AFO for activities of daily living * English or Spanish speaking * Able to comply with study procedures
Exclusion criteria
* Body mass less than 100 or greater than 275 lbs. * Over 80 years of age * Known cognitive impairment (e.g. diagnoses such as moderate/severe traumatic brain injury, dementia) * Inability to comply with instructions. * Pregnancy * Medical conditions that would preclude safe involvement * Unable to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Timed Up & Go | After 3-week accommodation period with device A and after 3-week accommodation period with device B. | The Timed Up\& Go (TUG) assesses mobility. In this test, subjects are timed while they rise from a chair, walk 3m, turn around, return to the chair and sit down again. Subjects are usually permitted to use a walking aid, but not to use physical assistance. |
| Two-minute Walk Test | After 3-week accommodation period with device A and after 3-week accommodation period with device B. | The Two-minute Walk Test (2MWT) assesses walking ability. Subjects will be asked to walk the greatest distance they can in 2 minutes while walking a 15.2m 'out and back' course until asked to stop. The distance walked will be recorded as will the post-test rate of perceived exertion (6-20 Borg RPE scale). |
| Four-Square-Step-Test | After 3-week accommodation period with device A and after 3-week accommodation period with device B. | The Four-Square-Step-Test is a balance and agility test where the patient changes direction quickly while maintaining balance. A 1-inch-high obstacle in the shape of a Maltese cross is placed on the floor. The patient is instructed to begin in the back, left quadrant then to move 1) forward, 2) sideways right, 3) backward, then 4) sideways left, then to move in the reverse direction back to the original square. They move as fast as possible through their movement progression while always keeping one foot on the floor. |
| Activities-Specific Balance Confidence Scale | After 3-week accommodation period with device A and after 3-week accommodation period with device B. | The Activities-Specific Balance Confidence Scale (ABC Scale) is a 16-item self-report tool that measures an individual's confidence in performing daily activities without losing balance or feeling unsteady. Participants rate their confidence for each activity on a 0% to 100% scale where 0% indicates no confidence and 100% indicates complete confidence. |
| Patient-Reported Outcomes Measurement Information System (PROMIS) | After 3-week accommodation period with device A and after 3-week accommodation period with device B. Monthly for 12 months after accommodation period with device B. | The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PROMIS-PI) is a standardized, self-reported tool designed to assess the extent to which pain disrupts a person's daily activities and quality of life. The PROMIS-PI evaluates the impact of pain on social, physical, emotional and cognitive functioning. Responses are rated on a 5-point scale from "never" to "very much" regarding how pain interfered with activities in the past week. |
| Orthotics and Prosthetics Users' Survey (OPUS) | After 3-week accommodation period with device A and after 3-week accommodation period with device B. Monthly for 12 months after accommodation period with device B. | The OPUS is a self-report questionnaire consisting of five modules. The following four modules related to the lower extremity will be used: 1) Lower Extremity Functional Status Measure, 2) Health Related Quality of Life Index, 3) Satisfaction with Devices and 4) Satisfaction with Services. The first two modules are based on a five-point Likert scale and nominal Yes/No scale while the latter two use a four-point Likert scale. Higher scores indicate better outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preference | Before and after each accommodation and training period. At 12 month follow-up. | Interviews with participants will be used to identify overall preference and device preference for different activities. Interviews will also ask about the specific needs, preferences, challenges, and limitations of using each device. |
| Activity monitoring | Monthly for 12 months after initial two accommodation and training periods | The activity monitors will measure active and sedentary periods of behavior. Specific variables estimated will include - time spent sitting, standing, stepping, time spent in sedentary, light and moderate-to-vigorous intensity activity, time spent in prolonged sitting bouts (e.g., sitting bouts \> 30 min, \> 60 min etc.), time spent in bouts of moderate-to-vigorous intensity (e.g., \> 10 minute bouts, i.e., activity bouts known to improve health), number of steps per day and number of sit-to-stand transitions per sedentary time. |
Countries
United States
Contacts
CONTACTStephanie L Carey, PhD
Outcome results
None listed