Improving Walking After a Lower Limb Injury Using a Custom Motorized Orthosis
ConditionLower Limb Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorKessler Foundation
About this trial
The purpose of this research study is to assess the ease, convenience, and efficacy of walking when using a motor powered ankle foot orthosis (AFO) brace, in adults who have had a lower limb injury.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have a lower limb injury greater than a year ago.
Be 18-80 years old.
Be able to stand for 30 minutes.
Have enough range of motion in my ankle to comfortably wear the AFO.
Disqualifiers
Have any joint or muscle tightness that would limit my movement while walking with the AFO.
Have any medical issue that prevents me from supporting my weight and walking (e.g. orthopedic injuries, pain, severe spasticity).
Have any medical issues that affect my unaffected side.
Have skin issues that would prevent wearing the device.
Trial design
Design model
Single group
Treatments tested in this trial
Utilization of motorized orthosis
DeviceWhile part of this study, participants will be fitted for the motorized orthosis and will complete walking tests with and without the AFO.
Treatment groups
19 Participants
are divided into 1 treatment groupGroup A: Adults with lower limb injuryExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
10MWT (Aim 1)
10 meter walk test to evaluate walking speed after lower limb injury and in response to the intervention. Walking evaluated without versus with the motorized orthosis.
Time frame
Measured before and after 6 week intervention to assess change from baseline.2
TUG (Aim 1)
Timed up and go (TUG) test to measure functional balance and walking ability after lower limb injury and in response to the intervention. Walking evaluated without versus with the motorized orthosis.
Time frame
Measured before and after 6 week intervention to assess change from baseline.3
6MWT (Aim 1)
6 minute walking test to evaluate endurance after lower limb injury and in response to the intervention. Walking evaluated without versus with the motorized orthosis.
Time frame
Measured before and after 6 week intervention to assess change from baseline.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Kessler Foundation
Lead sponsor
Stevens Institute of Technology
Collaborator
Source ClinicalTrials.gov