Lower-Limb AmputationEarly Phase 1NCT07486063
Motorized Prostheses for Lower-limb Amputees
A Early Phase 1 study of Lower-Limb Amputation, run by University of Utah at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower-Limb Amputation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to Jun 2032
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Our inclusion criteria will be
- Above-knee amputation
- K2/K3/K4 ambulators
- At least 18 years old
- At least one year since amputation
- At least six months since the definitive prosthesis fitting
- Currently prescribed and using a mechanically passive or microprocessor-controlled prosthesis
Our exclusion criteria will be
- 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.)
- Adults who are unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Individuals who use a wheelchair for mobility both outdoors and indoors because they may not be able to perform the necessary activities with their passive prosthesis or the powered prosthesis
- Prisoners, due to concerns with informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Utah
Salt Lake City, Utah, 84112
Tommaso Lenzi, PhD, 3126190442, t.lenzi@utah.edu
Rosie Murray, PhD, 8012133637, rosemarie.murray@utah.edu
About this study
Official title: Lightweight Motorized Prostheses for Lower-limb Amputees
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.
Read the detailed description
AIM1:
For all studies, participants will repeat the same experimental protocol with their passive prostheses and our lightweight powered knee combined with powered, semi-active, and passive ankle. The investigators will also administer a questionnaire based on a 5-point Likert scale to rate intuitiveness, safety, physical demand, and mental demand for each tested condition. Participants will have time to familiarize themselves with the protocol and the prosthesis in a separate training session.
Part 1: Level and Inclined Walking Effort. The study will assess walking effort as participants walk on an instrumented treadmill at their self-selected comfortable speed. The primary outcome of the first study will be residual limb effort measured through peak hip flexion torque on the prosthesis side. Secondary outcomes will include contralateral leg effort, gait symmetry, and balance. The experimental protocol will be repeated for different inclines (e.g., 0%, +/-10%) during separate experimental sessions.
Part 2: Ambulation on Stairs. The study will analyze speed and effort during stair ascent and descent. Participants will ambulate on an instrumented staircase that includes seven steps (four instrumented). The primary outcome for stair ascent will be the ratio between prosthesis work and residual limb work, whereas, for stair descent, the investigators will use sound knee and ankle work. Residual limb, contralateral leg, and upper body effort (handrail force) will be the secondary outcomes, together with subjective preference.
Part 3: Sit-to-Stand Transitions. This study will assess biomechanics as the participant transitions between sitting and standing. Participants will perform sit-to-stand and stand-to-sit transitions from a chair with no armrests at their self-selected pace. The investigators will assess full-body biomechanics similar to our previous sit-to-stand and stand-to-sit studies. The primary outcome of this study will be the degree of asymmetry.
AIM2:
Participants will repeat the experimental protocols with their prescribed prostheses and our lightweight powered prosthesis using direct electromyographic control and indirect volitional control. The experiments will be conducted in a motion capture lab to assess full-body kinematics and kinetics. The investigators will also administer a questionnaire based on a 5-point Likert scale to rate intuitiveness, safety, physical demand, and mental demand for each tested condition. Participants will have time to familiarize themselves with the protocol and the prosthesis controllers in dedicated training sessions.
Part 1: Inclined Walking at different speeds and loading conditions. This study will assess the ability to walk at various speeds on inclines/declines while carrying objects. To this end, participants will walk on an instrumented treadmill both at their self-selected speed and 130% of their self-selected speed with and without holding a 20-lb load in both hands. The difference between hip peak torque on the sound and prosthesis sides will be used as a primary outcome. Secondary outcomes will include gait symmetry, balance, and subjective preference. During separate sessions, the experimental protocol will be repeated at 10% incline and 10% decline.
Part 2: Stair Climbing at different speeds and loading conditions. This study will assess the ability to ascend and descend stairs under different speeds and loading conditions. Participants will ascend an instrumented staircase at comfortable and fast self-selected speeds. Participants will climb stairs at both speeds with and without a 20-lb object carried in their hands or a backpack. The difference between knee peak torque on the sound and prosthesis sides will be used as a primary outcome. Secondary outcomes will include contralateral leg effort, gait symmetry, and balance.
Part 3: Stand up, Squat, Lunge, and Kneel. This study will assess the ability to stand up, squat, and lunge under different loading conditions. Participants will perform five repetitions of sit-to-stand transfers. Then, they will squat, lunge, and kneel five times. The primary outcome will be prosthesis weight-bearing. Secondary outcomes will include time to completion, joint effort, and subjective preference.
AIM3:
Participants will repeat the experimental protocols with their prescribed prostheses and our lightweight powered prosthesis. During dedicated training sessions, they will have time to familiarize themselves with the protocol.
Part 1 Ambulation Circuit. Participants will perform ten trials of the ambulation circuit. Starting in a chair, standing up, walking to a 4-step staircase, climbing up the stairs to an elevated platform, continuing to walk on the platform, turning, descending an intermediate platform using a two-step staircase, descending a ramp, walking to the chair, and ending by sitting down. Next, ten trials of the reverse circuit will be completed, starting with sitting in the chair and ending with the ramp ascent. The primary outcome will be the average time to complete the circuit. Secondary outcomes will be joint kinematics during transitions and subjective preference.
Part 2: Self-Selected Walking Speed. Participants will perform the timed 10-meter walking test on a self-paced instrumented treadmill. Walking speed will be the primary outcome. Secondary outcomes will include spatiotemporal gait symmetry and subjective preference.
Part 3: Amputee Mobility Predictor. This study aims to assess clinical outcome measures using the Amputee Mobility Predictor, a reliable performance measure validated for those with lower-limb loss, to identify limitations in prosthetic mobility and measure several functional mobility tasks needed during daily living activities.
Part 4: Real-World Mobility. This study will provide a quantitative assessment of mobility in complex home and community environments. To this end, the investigators will measure performance and satisfaction while participants perform common activities of daily living, which will include household chores (mopping floors, making beds, cooking, grocery shopping) and leisure activities (walking the dog, strolling in a park, gardening). Subjective preference will be the primary outcome and will be assessed by administering a questionnaire with separate ratings for intuitiveness, safety, physical demand, and mental demand. The secondary outcome will be kinematics, which the investigators will assess using an IMU-based motion capture system.
- Conditions
- Lower-Limb Amputation
- Being tested
- Powered and passive lower limb prosthesis and control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Powered and passive lower limb prosthesis and controlDevice
Effect of prosthesis function on mobility and ambulation
| Study group | Role | What they receive |
|---|---|---|
| Main Arm | Experimental | Powered and passive lower limb prosthesis and control Receives: Device: Powered and passive lower limb prosthesis and control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and Day 1
Ten-meter walking test
The 10-meter walking test assesses walking speed in meters per second over a short duration.
Measured: Baseline and Day 1
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.
Measured: Baseline and Day 1
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
Measured: Baseline and Day 1
Prosthesis weight-bearing
Vertical ground reaction force generated by the user on the prosthesis side when standing up and sitting down from a chair.
Measured: Baseline and Day 1
Knee torque symmetry
Difference between the knee peak torque on the sound side and on the prosthesis side when the subject climb stairs at different speeds and loading conditions.
Measured: Baseline and Day 1
Hip torque symmetry
Difference between the hip peak torque on the sound side and on the prosthesis side when the subject walks on inclines at different speeds and loading conditions.
Measured: Baseline and Day 1
Weight bearing asymmetry
Difference between the vertical ground reaction force on the prosthesis side and the sound side when the subject stands up and sits down from a chair.
Measured: Baseline and Day 1
Prosthesis to residual-limb work ratio
Ratio between the mechanical work generated by the prosthesis and the residual limb when ascending and descending stairs.
Measured: Baseline and Day 1
Residual limb effort
Peak hip flexion torque on the prosthesis side when subjects walk at different speeds and inclines.
Measured: Baseline and Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start1 Jul 2025
- Primary completionMay 2031 (estimated)
- Study completionJun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower-Limb AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Tommaso Lenzi, University of Utah
- Investigators
- Tommaso Lenzi, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486063
- Sponsor's protocol ID
- IRB_00103197
- Other IDs
- R01HD098154
- Status last verified
- Aug 2026
- First submitted
- 12 Mar 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lightweight Motorized Prostheses for Lower-limb Amputees
- ClinicalTrials.gov ID
- NCT07486063
- Acronym / sponsor ID
- IRB_00103197
- Conditions
- Lower-Limb Amputation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- May 2031 (estimated)
- Study completion
- Jun 2032 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
AIM1:
For all studies, participants will repeat the same experimental protocol with their passive prostheses and our lightweight powered knee combined with powered, semi-active, and passive ankle. The investigators will also administer a questionnaire based on a 5-point Likert scale to rate intuitiveness, safety, physical demand, and mental demand for each tested condition. Participants will have time to familiarize themselves with the protocol and the prosthesis in a separate training session.
Part 1: Level and Inclined Walking Effort. The study will assess walking effort as participants walk on an instrumented treadmill at their self-selected comfortable speed. The primary outcome of the first study will be residual limb effort measured through peak hip flexion torque on the prosthesis side. Secondary outcomes will include contralateral leg effort, gait symmetry, and balance. The experimental protocol will be repeated for different inclines (e.g., 0%, +/-10%) during separate experimental sessions.
Part 2: Ambulation on Stairs. The study will analyze speed and effort during stair ascent and descent. Participants will ambulate on an instrumented staircase that includes seven steps (four instrumented). The primary outcome for stair ascent will be the ratio between prosthesis work and residual limb work, whereas, for stair descent, the investigators will use sound knee and ankle work. Residual limb, contralateral leg, and upper body effort (handrail force) will be the secondary outcomes, together with subjective preference.
Part 3: Sit-to-Stand Transitions. This study will assess biomechanics as the participant transitions between sitting and standing. Participants will perform sit-to-stand and stand-to-sit transitions from a chair with no armrests at their self-selected pace. The investigators will assess full-body biomechanics similar to our previous sit-to-stand and stand-to-sit studies. The primary outcome of this study will be the degree of asymmetry.
AIM2:
Participants will repeat the experimental protocols with their prescribed prostheses and our lightweight powered prosthesis using direct electromyographic control and indirect volitional control. The experiments will be conducted in a motion capture lab to assess full-body kinematics and kinetics. The investigators will also administer a questionnaire based on a 5-point Likert scale to rate intuitiveness, safety, physical demand, and mental demand for each tested condition. Participants will have time to familiarize themselves with the protocol and the prosthesis controllers in dedicated training sessions.
Part 1: Inclined Walking at different speeds and loading conditions. This study will assess the ability to walk at various speeds on inclines/declines while carrying objects. To this end, participants will walk on an instrumented treadmill both at their self-selected speed and 130% of their self-selected speed with and without holding a 20-lb load in both hands. The difference between hip peak torque on the sound and prosthesis sides will be used as a primary outcome. Secondary outcomes will include gait symmetry, balance, and subjective preference. During separate sessions, the experimental protocol will be repeated at 10% incline and 10% decline.
Part 2: Stair Climbing at different speeds and loading conditions. This study will assess the ability to ascend and descend stairs under different speeds and loading conditions. Participants will ascend an instrumented staircase at comfortable and fast self-selected speeds. Participants will climb stairs at both speeds with and without a 20-lb object carried in their hands or a backpack. The difference between knee peak torque on the sound and prosthesis sides will be used as a primary outcome. Secondary outcomes will include contralateral leg effort, gait symmetry, and balance.
Part 3: Stand up, Squat, Lunge, and Kneel. This study will assess the ability to stand up, squat, and lunge under different loading conditions. Participants will perform five repetitions of sit-to-stand transfers. Then, they will squat, lunge, and kneel five times. The primary outcome will be prosthesis weight-bearing. Secondary outcomes will include time to completion, joint effort, and subjective preference.
AIM3:
Participants will repeat the experimental protocols with their prescribed prostheses and our lightweight powered prosthesis. During dedicated training sessions, they will have time to familiarize themselves with the protocol.
Part 1 Ambulation Circuit. Participants will perform ten trials of the ambulation circuit. Starting in a chair, standing up, walking to a 4-step staircase, climbing up the stairs to an elevated platform, continuing to walk on the platform, turning, descending an intermediate platform using a two-step staircase, descending a ramp, walking to the chair, and ending by sitting down. Next, ten trials of the reverse circuit will be completed, starting with sitting in the chair and ending with the ramp ascent. The primary outcome will be the average time to complete the circuit. Secondary outcomes will be joint kinematics during transitions and subjective preference.
Part 2: Self-Selected Walking Speed. Participants will perform the timed 10-meter walking test on a self-paced instrumented treadmill. Walking speed will be the primary outcome. Secondary outcomes will include spatiotemporal gait symmetry and subjective preference.
Part 3: Amputee Mobility Predictor. This study aims to assess clinical outcome measures using the Amputee Mobility Predictor, a reliable performance measure validated for those with lower-limb loss, to identify limitations in prosthetic mobility and measure several functional mobility tasks needed during daily living activities.
Part 4: Real-World Mobility. This study will provide a quantitative assessment of mobility in complex home and community environments. To this end, the investigators will measure performance and satisfaction while participants perform common activities of daily living, which will include household chores (mopping floors, making beds, cooking, grocery shopping) and leisure activities (walking the dog, strolling in a park, gardening). Subjective preference will be the primary outcome and will be assessed by administering a questionnaire with separate ratings for intuitiveness, safety, physical demand, and mental demand. The secondary outcome will be kinematics, which the investigators will assess using an IMU-based motion capture system.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main Arm | Experimental | Device: Powered and passive lower limb prosthesis and controlPowered and passive lower limb prosthesis and control |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Powered and passive lower limb prosthesis and controlEffect of prosthesis function on mobility and ambulation | Device | Main Arm |
Primary outcome
Amputee Mobility Predictor with Prosthesis (AMPPRO)
Time frame: Baseline and Day 1
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
Ten-meter walking test
Time frame: Baseline and Day 1
The 10-meter walking test assesses walking speed in meters per second over a short duration.
Ambulation circuit
Time frame: Baseline and Day 1
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.
Usability questionnaire
Time frame: Baseline and Day 1
A custom questionnaire based on a 5-point Likert scale to rate intuitiveness, safety, physical demand, and mental demand for each tested condition
Prosthesis weight-bearing
Time frame: Baseline and Day 1
Vertical ground reaction force generated by the user on the prosthesis side when standing up and sitting down from a chair.
Knee torque symmetry
Time frame: Baseline and Day 1
Difference between the knee peak torque on the sound side and on the prosthesis side when the subject climb stairs at different speeds and loading conditions.
Hip torque symmetry
Time frame: Baseline and Day 1
Difference between the hip peak torque on the sound side and on the prosthesis side when the subject walks on inclines at different speeds and loading conditions.
Weight bearing asymmetry
Time frame: Baseline and Day 1
Difference between the vertical ground reaction force on the prosthesis side and the sound side when the subject stands up and sits down from a chair.
Prosthesis to residual-limb work ratio
Time frame: Baseline and Day 1
Ratio between the mechanical work generated by the prosthesis and the residual limb when ascending and descending stairs.
Residual limb effort
Time frame: Baseline and Day 1
Peak hip flexion torque on the prosthesis side when subjects walk at different speeds and inclines.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
Related trials for Lower-Limb Amputation
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Impact of Footwear on Gait in Unilateral Transtibial Amputees
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TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
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Core Muscle Function and Postural Control in Lower Extremity Amputees
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tommaso Lenzi, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study of Lower-Limb Amputation, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tommaso Lenzi, PhD (3126190442, t.lenzi@utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amputee Mobility Predictor with Prosthesis (AMPPRO) (time frame: Baseline and Day 1). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.