IM ABLE 2: Injuries Managed With Advanced Bracing for Lower Extremities
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of South Florida
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Advanced Ankle Foot Orthosis (AFO)
DeviceSubjects 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.
Conventional Ankle Foot Orthosis (AFO)
DeviceSubjects 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.
Treatment groups
75 Participants
are divided into 2 treatment groupsGroup A: Conventional Ankle Foot Orthosis (AFO)Active comparator 1 intervention
Group B: Advanced Ankle Foot Orthosis (AFO)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Timed Up & Go
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.
Time frame
After 3-week accommodation period with device A and after 3-week accommodation period with device B.2
Two-minute Walk Test
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).
Time frame
After 3-week accommodation period with device A and after 3-week accommodation period with device B.3
Four-Square-Step-Test
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.
Time frame
After 3-week accommodation period with device A and after 3-week accommodation period with device B.4
Activities-Specific Balance Confidence Scale
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.
Time frame
After 3-week accommodation period with device A and after 3-week accommodation period with device B.Secondary outcomes
1
Preference
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.
Time frame
Before and after each accommodation and training period. At 12 month follow-up.2
Activity monitoring
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.
Time frame
Monthly for 12 months after initial two accommodation and training periodsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of South Florida
Lead sponsor
Tampa VA Healthcare System
Collaborator
VA New York Harbor Healthcare System
Collaborator
Source ClinicalTrials.gov