Recruiting
Early Phase 1

Powered Prosthesis

Sponsor:

University of Utah

Code:

NCT07486063

Conditions

Lower-Limb Amputation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Powered and passive lower limb prosthesis and control

Study Details

Brief 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.

Conditions

Lower-Limb Amputation

Study ID

NCT07486063

Start date

Jul 1, 2025

Status verified date

Aug, 2026

Completion date

Jun, 2032

Anticipated

Primary completion date

May, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Main Arm

Powered and passive lower limb prosthesis and control

Interventions

Powered and passive lower limb prosthesis and control

Effect of prosthesis function on mobility and ambulation

Primary outcome measure

  • Amputee Mobility Predictor with Prosthesis (AMPPRO) [ Time Frame: Baseline and Day 1 ]
  • Ten-meter walking test [ Time Frame: Baseline and Day 1 ]
  • Ambulation circuit [ Time Frame: Baseline and Day 1 ]
  • Usability questionnaire [ Time Frame: Baseline and Day 1 ]
  • Prosthesis weight-bearing [ Time Frame: Baseline and Day 1 ]
  • Knee torque symmetry [ Time Frame: Baseline and Day 1 ]
  • Hip torque symmetry [ Time Frame: Baseline and Day 1 ]
  • Weight bearing asymmetry [ Time Frame: Baseline and Day 1 ]
  • Prosthesis to residual-limb work ratio [ Time Frame: Baseline and Day 1 ]
  • Residual limb effort [ Time Frame: Baseline and Day 1 ]

Central Contacts and Locations

Central contacts

Tommaso Lenzi, PhD

3126190442t.lenzi@utah.edu

Rosie Murray, PhD

8012133637rosemarie.murray@utah.edu

Locations

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Tommaso Lenzi, PhD

3126190442t.lenzi@utah.edu

Rosie Murray, PhD

8012133637rosemarie.murray@utah.edu

Principal Investigator:

Tommaso Lenzi, PhD

More Information

Sponsor

University of Utah

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2026-08-14.