Artificial Limbs, Transtibial Amputation
Conditions
Brief summary
The purpose of this research is to validate the e-MIP design and function by testing the ability of e-MIP to harvest energy and return a sufficient amount of energy to assist the user during gait. The investigators will also evaluate whether prosthetic users are able to wear and use the e-MIP device long-term.
Interventions
DEVICEHabitual Prosthesis
Habitual baseline prosthesis prescribed by participant's clinician.
DEVICEEnergy-Harvesting Mesofluidic Impulse Prosthesis
e-MIP is an experimental lower limb ankle-foot prosthesis.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Orthocare Innovations, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Crossover clinical trial
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Unilateral transtibial amputation * At least twelve months post-amputation * Currently walking on a prosthesis for at least one year * Uses modular endoskeletal prosthetic components * Has bilateral normal range of motion * Ability to walk independently and for an extended length of time (walking ability of each individual will be assessed by the principal investigator or study prosthetist during the recruitment period) * Ability to communicate individual perceptions * Ability to provide informed consent
Exclusion criteria
* Confounding injury or musculoskeletal problem * Pregnancy * Lower limb peripheral neuropathy * Symptomatic cardiovascular disease or chronic obstructive pulmonary disease * Not able to read and understand English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Energy returned | After four weeks with Habitual Prosthesis | The amount of energy returned at the ankle joint, calculated from ankle torque and angle sensors with respect to time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Step Rate | After four weeks with Habitual Prosthesis | The speed of steps taken by the participant will be recorded over four weeks with a step activity monitor. |
| Step Activity | After four weeks with Habitual Prosthesis | The number of continuous steps taken by the participant will be recorded over four weeks with a step activity monitor. |
| Prosthesis Evaluation Questionnaire | After four weeks with Habitual Prosthesis | Responses to the psychometrically validated scales of the Prosthesis Evaluation Questionnaire for persons with limb loss, in order to understand the participant's perception of the prosthesis. Questionnaire scores range from 0 to 100. Higher scores indicate a better outcome. |
| Total Steps | After four weeks with Habitual Prosthesis | The number of steps taken by the participant will be recorded over four weeks with a step activity monitor. |
| Kinematics during Gait | After four weeks with Habitual Prosthesis | Kinematics such as hip, knee, and ankle joint angles will be measured using motion analysis. |
| Kinetics during Gait | After four weeks with Habitual Prosthesis | Kinetics such as hip, knee, and ankle joint torques will be measured using motion analysis. |
| Spatio-Temporal Gait Parameters | After four weeks with Habitual Prosthesis | The spatio-temporal parameters of gait, such as walking speed, will be measured using motion analysis. |
Countries
United States
Outcome results
None listed