Motorized Prostheses for Lower-limb Amputees
ConditionLower-Limb Amputation
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Utah
About this trial
The investigators will assess biomechanical and functional mobility outcomes in individuals with unilateral, above-knee amputations using different knee/ankle configurations of a lightweight powered prosthesis and different volitional controllers in individuals with unilateral, above-knee amputations.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Above-knee amputation
K2/K3/K4 ambulators
At least 18 years old
At least one year since amputation
Disqualifiers
Over 350 lbs. body weight, the weight limit for our safety suspension systems
Cognitive deficits or visual impairment that could impair their ability to give informed consent or to follow simple instructions during the experiments
Pregnant women due to elevated safety concerns for this population
Co-morbidity that limits their ability to participate in the study protocol (e.g., stroke, pacemaker placement that would interfere with the powered prosthesis, severe ischemia, cardiac disease, etc.)
Trial design
Design model
Single group
Treatments tested in this trial
Powered and passive lower limb prosthesis and control
DeviceEffect of prosthesis function on mobility and ambulation
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Main ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Amputee Mobility Predictor with Prosthesis (AMPPRO)
The AMPPRO is used to assess functional mobility through a standardized sequence of mobility tests while using a prosthesis. Individual tasks are scored and combined, resulting in a total assessment. The minimum score is zero, and the maximum score on this scale is 47. Higher scores indicate better mobility
Time frame
Baseline and Day 12
Ten-meter walking test
The 10-meter walking test assesses walking speed in meters per second over a short duration.
Time frame
Baseline and Day 13
Ambulation circuit
Average time to complete an ambulation circuit that requires subjects to standup from a chair, walk to a 4-step staircase, climb up the staircase to an elevated platform, continue to walk on the platform, turn, descend an intermediate platform using a two-step staircase, descending a ramp, walking to the chair, and ending by sitting down.
Time frame
Baseline and Day 14
Usability questionnaire
A custom questionnaire based on a 5-point Likert scale to rate intuitiveness, safety, physical demand, and mental demand for each tested condition
Time frame
Baseline and Day 1Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Utah
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov