Transtibial AmputationNCT04157608
Energy-Harvesting Mesofluidic Impulse Prosthesis: e-MIP
A study testing Habitual Prosthesis and Energy-Harvesting Mesofluidic Impulse Prosthesis in people with Transtibial Amputation and Artificial Limbs, run by Orthocare Innovations, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Transtibial Amputation, Artificial Limbs
- What is being tested?
- Habitual Prosthesis and Energy-Harvesting Mesofluidic Impulse Prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2019to 10 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Orthocare Innovations, LLC
Edmonds, Washington, 98020
About this study
Official title: Evaluation of an Energy-Harvesting Mesofluidic Impulse Prosthesis (e-MIP) in Transtibial Prosthesis Users
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.
- Conditions
- Transtibial Amputation, Artificial Limbs
- Being tested
- Habitual Prosthesis, Energy-Harvesting Mesofluidic Impulse Prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Habitual ProsthesisDevice
Habitual baseline prosthesis prescribed by participant's clinician.
Energy-Harvesting Mesofluidic Impulse ProsthesisDevice
e-MIP is an experimental lower limb ankle-foot prosthesis.
| Study group | Role | What they receive |
|---|---|---|
| Habitual Prosthesis | Active comparator | Participant's existing baseline prescribed prosthesis Receives: Device: Habitual Prosthesis |
| e-MIP | Experimental | Experimental ankle-foot prosthesis Receives: Device: Energy-Harvesting Mesofluidic Impulse Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy returned
The amount of energy returned at the ankle joint, calculated from ankle torque and angle sensors with respect to time.
Measured: After four weeks with Habitual Prosthesis
Energy returned
The amount of energy returned at the ankle joint, calculated from ankle torque and angle sensors with respect to time.
Measured: After four weeks with e-MIP (system ON and system OFF)
Secondary outcomes (14)
Total Steps
The number of steps taken by the participant will be recorded over four weeks with a step activity monitor.
Measured: After four weeks with Habitual Prosthesis
Total Steps
The number of steps taken by the participant will be recorded over four weeks with a step activity monitor.
Measured: After four weeks with e-MIP (system ON and system OFF)
Step Rate
The speed of steps taken by the participant will be recorded over four weeks with a step activity monitor.
Measured: After four weeks with Habitual Prosthesis
Step Rate
The speed of steps taken by the participant will be recorded over four weeks with a step activity monitor.
Measured: After four weeks with e-MIP (system ON and system OFF)
Step Activity
The number of continuous steps taken by the participant will be recorded over four weeks with a step activity monitor.
Measured: After four weeks with Habitual Prosthesis
Step Activity
The number of continuous steps taken by the participant will be recorded over four weeks with a step activity monitor.
Measured: After four weeks with e-MIP (system ON and system OFF)
Prosthesis Evaluation Questionnaire
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.
Measured: After four weeks with Habitual Prosthesis
Prosthesis Evaluation Questionnaire
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.
Measured: After four weeks with e-MIP (system ON and system OFF)
Spatio-Temporal Gait Parameters
The spatio-temporal parameters of gait, such as walking speed, will be measured using motion analysis.
Measured: After four weeks with Habitual Prosthesis
Spatio-Temporal Gait Parameters
The spatio-temporal parameters of gait, such as walking speed, will be measured using motion analysis.
Measured: After four weeks with e-MIP (system ON and system OFF)
Kinematics during Gait
Kinematics such as hip, knee, and ankle joint angles will be measured using motion analysis.
Measured: After four weeks with Habitual Prosthesis
Kinematics during Gait
Kinematics such as hip, knee, and ankle joint angles will be measured using motion analysis.
Measured: After four weeks with e-MIP (system ON and system OFF)
Kinetics during Gait
Kinetics such as hip, knee, and ankle joint torques will be measured using motion analysis.
Measured: After four weeks with Habitual Prosthesis
Kinetics during Gait
Kinetics such as hip, knee, and ankle joint torques will be measured using motion analysis.
Measured: After four weeks with e-MIP (system ON and system OFF)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start2 Oct 2019
- Primary completion10 Jul 2022
- Study completion10 Jul 2022
Why it stopped: Investigational device under development
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transtibial 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
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Crossover clinical trial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthocare Innovations, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04157608
- Sponsor's protocol ID
- 0309-02
- Other IDs
- 2R44HD080309
- Status last verified
- Oct 2023
- First submitted
- 31 Oct 2019
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Energy-Harvesting Mesofluidic Impulse Prosthesis (e-MIP) in Transtibial Prosthesis Users
- ClinicalTrials.gov ID
- NCT04157608
- Acronym / sponsor ID
- 0309-02
- Conditions
- Transtibial Amputation, Artificial Limbs
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigational device under development
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Orthocare Innovations, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- 10 Jul 2022 (actual)
- Study completion
- 10 Jul 2022 (actual)
- First posted
- 8 Nov 2019 (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 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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Crossover clinical trial
| Arm | Type | Receives |
|---|---|---|
| Habitual Prosthesis | Active comparator | Device: Habitual ProsthesisParticipant's existing baseline prescribed prosthesis |
| e-MIP | Experimental | Device: Energy-Harvesting Mesofluidic Impulse ProsthesisExperimental ankle-foot prosthesis |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Habitual ProsthesisHabitual baseline prosthesis prescribed by participant's clinician. | Device | Habitual Prosthesis |
| Energy-Harvesting Mesofluidic Impulse Prosthesise-MIP is an experimental lower limb ankle-foot prosthesis. | Device | e-MIP |
Primary outcome
Energy returned
Time frame: 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.
Energy returned
Time frame: After four weeks with e-MIP (system ON and system OFF)
The amount of energy returned at the ankle joint, calculated from ankle torque and angle sensors with respect to time.
14 secondary outcomes
Total Steps
Time frame: After four weeks with Habitual Prosthesis
Total Steps
Time frame: After four weeks with e-MIP (system ON and system OFF)
Step Rate
Time frame: After four weeks with Habitual Prosthesis
Step Rate
Time frame: After four weeks with e-MIP (system ON and system OFF)
Step Activity
Time frame: After four weeks with Habitual Prosthesis
Step Activity
Time frame: After four weeks with e-MIP (system ON and system OFF)
Prosthesis Evaluation Questionnaire
Time frame: After four weeks with Habitual Prosthesis
Prosthesis Evaluation Questionnaire
Time frame: After four weeks with e-MIP (system ON and system OFF)
Spatio-Temporal Gait Parameters
Time frame: After four weeks with Habitual Prosthesis
Spatio-Temporal Gait Parameters
Time frame: After four weeks with e-MIP (system ON and system OFF)
Kinematics during Gait
Time frame: After four weeks with Habitual Prosthesis
Kinematics during Gait
Time frame: After four weeks with e-MIP (system ON and system OFF)
Kinetics during Gait
Time frame: After four weeks with Habitual Prosthesis
Kinetics during Gait
Time frame: After four weeks with e-MIP (system ON and system OFF)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Habitual Prosthesis and Energy-Harvesting Mesofluidic Impulse Prosthesis in people with Transtibial Amputation and Artificial Limbs, run by Orthocare Innovations, LLC 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?
The sponsor lists 8 inclusion and 5 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 10 Oct 2023. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy returned (time frame: After four weeks with Habitual Prosthesis). The study lists 2 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 10 Oct 2023.