Transfemoral AmputationNCT04023045
Assist-Knee: Energy-Harvesting Knee Prosthesis
A study testing Assist-Knee and Habitual Prosthesis in people with Transfemoral 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 Assist-Knee design and function by collecting pilot data during the stand-to-sit-to-stand transition in transfemoral prosthesis users when using the Assist-Knee to harvest energy and return energy . Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Transfemoral Amputation, Artificial Limbs
- What is being tested?
- Assist-Knee and Habitual Prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2019to 26 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral transfemoral limb loss
- At least one year post-amputation and currently successfully using a prosthesis
- Uses modular endoskeletal prosthetic components
- Has bilateral normal range of motion
- Ability to perform the following activities:
- Walking ability or ability to take steps over 10 meters
Show all 11Show fewer
- Upright standing stability
- Stand-to-sit stability (i.e. go from a standing position to a seated position independently)
- Sit-to-stand stability (i.e. rise from a seated position independently)
- Ability to communicate individual perceptions in the English language
- 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
- Use of assistive devices for sit-to-stand and stand-to-sit (e.g. canes, walkers)
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 Knee Prosthesis in Transfemoral Prosthesis Users
The purpose of this research is to validate the Assist-Knee design and function by collecting pilot data during the stand-to-sit-to-stand transition in transfemoral prosthesis users when using the Assist-Knee to harvest energy and return energy .
- Conditions
- Transfemoral Amputation, Artificial Limbs
- Being tested
- Assist-Knee, Habitual Prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assist-KneeDevice
Assist-Knee is an experimental lower limb knee prosthesis.
Habitual ProsthesisDevice
Habitual baseline prosthesis prescribed by participant's clinician.
| Study group | Role | What they receive |
|---|---|---|
| Habitual Prosthesis | Active comparator | Participant's prescribed prosthesis Receives: Device: Habitual Prosthesis |
| Assist-Knee | Experimental | Experimental knee prosthesis Receives: Device: Assist-Knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Complete Sit-to-Stand
The amount of time, measured in seconds, needed by the subject to complete the sit-to-stand transition. At least four trials of the sit-to-stand maneuver were collected for each participant using a motion analysis system. Average and standard deviation of the time to complete the sit-to-stand transition were calculated for each participant (each participant served as their own control in this pilot study). The start of the transition was determined by participant initiation; the end of the transition was determined by the participant reaching full knee extension.
Measured: Collection at baseline
Time to Complete Sit-to-Stand
The amount of time, measured in seconds, needed by the subject to complete the sit-to-stand transition. At least four trials of the sit-to-stand maneuver were collected for each participant using a motion analysis system. Average and standard deviation of the time to complete the sit-to-stand transition were calculated for each participant (each participant served as their own control in this pilot study). The start of the transition was determined by participant initiation; the end of the transition was determined by the participant reaching full knee extension.
Measured: After acclimation to Assist-Knee (Participants are given at least 10 minutes and no more than 60 minutes to acclimate to each Assist-Knee condition for safety. After acclimating, participants will complete the maneuver to measure this outcome.)
Secondary outcomes (6)
Timed Up and Go (TUG) Test
The Timed Up and Go (TUG) test is a validated timed functional test that involves standing up from a chair, walking forward for 3 meters, turning around, walking back to the chair for 3 meter, and sitting down. Each participant completed the TUG test for three trials. Time was measured using a stopwatch. Average and standard deviation of the time to complete the TUG test were calculated for each participant (each participant served as their own control in this pilot study).
Measured: Collection at baseline
Timed Up and Go (TUG) Test
The Timed Up and Go (TUG) test is a validated timed functional test that involves standing up from a chair, walking forward for 3 meters, turning around, walking back to the chair for 3 meter, and sitting down. Each participant completed the TUG test for three trials. Time was measured using a stopwatch. Average and standard deviation of the time to complete the TUG test were calculated for each participant (each participant served as their own control in this pilot study).
Measured: After acclimation to Assist-Knee (Participants are given at least 10 minutes and no more than 60 minutes to acclimate to each Assist-Knee condition for safety. After acclimating, participants will complete the maneuver to measure this outcome.)
Time to Complete Stand-to-Sit
The amount of time, measured in seconds, needed by the subject to complete the stand-to-sit transition. At least four trials of the stand-to-sit maneuver were collected for each participant using a motion analysis system. Average and standard deviation of the time to complete the stand-to-sit transition were calculated for each participant (each participant served as their own control in this pilot study). The start of the transition was determined by participant initiation; the end of the transition was determined by the participant being seated on a chair.
Measured: Collection at baseline
Time to Complete Stand-to-Sit
The amount of time, measured in seconds, needed by the subject to complete the stand-to-sit transition. At least four trials of the stand-to-sit maneuver were collected for each participant using a motion analysis system. Average and standard deviation of the time to complete the stand-to-sit transition were calculated for each participant (each participant served as their own control in this pilot study). The start of the transition was determined by participant initiation; the end of the transition was determined by the participant being seated on a chair.
Measured: After acclimation to Assist-Knee (Participants are given at least 10 minutes and no more than 60 minutes to acclimate to each Assist-Knee condition for safety. After acclimating, participants will complete the maneuver to measure this outcome.)
Percentage of Body Weight on Contralateral Limb at 65 Degrees Knee Flexion
The percentage of body weight on the contralateral limb was determined for both stand-to-sit and sit-to-stand transitions at 65 degrees knee flexion. A force plate under the contralateral limb recorded the amount of loading on the limb during the stand-to-sit and sit-to-stand transitions. The amount of contralateral limb loading at 65 degrees knee flexion was determined and divided by the participant's total loading due to overall body weight. This value was then converted to a percentage.
Measured: Collection at baseline
Percentage of Body Weight on Contralateral Limb at 65 Degrees Knee Flexion
The percentage of body weight on the contralateral limb was determined for both stand-to-sit and sit-to-stand transitions at 65 degrees knee flexion. A force plate under the contralateral limb recorded the amount of loading on the limb during the stand-to-sit and sit-to-stand transitions. The amount of contralateral limb loading at 65 degrees knee flexion was determined and divided by the participant's total loading due to overall body weight. This value was then converted to a percentage.
Measured: After acclimation to Assist-Knee (Participants are given at least 10 minutes and no more than 60 minutes to acclimate to each Assist-Knee condition for safety. After acclimating, participants will complete the maneuver to measure this outcome.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start15 Jul 2019
- Primary completion26 Feb 2020
- Study completion26 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Transfemoral 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
- 3 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
- Investigators
- Sarah Chang, PhD, Principal investigator, Orthocare Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023045
- Sponsor's protocol ID
- 7826-01
- Other IDs
- 1R43HD097826
- Status last verified
- Oct 2023
- First submitted
- 27 Jun 2019
- Last updated
- 18 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Energy-Harvesting Knee Prosthesis in Transfemoral Prosthesis Users
- ClinicalTrials.gov ID
- NCT04023045
- Acronym / sponsor ID
- 7826-01
- Conditions
- Transfemoral Amputation, Artificial Limbs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 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
- 15 Jul 2019 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 17 Jul 2019 (actual)
- Results
- Posted 7 Oct 2022
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 Assist-Knee design and function by collecting pilot data during the stand-to-sit-to-stand transition in transfemoral prosthesis users when using the Assist-Knee to harvest energy and return energy .
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 prescribed prosthesis |
| Assist-Knee | Experimental | Device: Assist-KneeExperimental knee prosthesis |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Unilateral transfemoral limb loss
- At least one year post-amputation and currently successfully using a prosthesis
- Uses modular endoskeletal prosthetic components
- Has bilateral normal range of motion
- Ability to perform the following activities:
Key exclusion criteria (6 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 |
|---|---|---|
| Assist-KneeAssist-Knee is an experimental lower limb knee prosthesis. | Device | Assist-Knee |
| Habitual ProsthesisHabitual baseline prosthesis prescribed by participant's clinician. | Device | Habitual Prosthesis |
Primary outcome
Time to Complete Sit-to-Stand
Time frame: Collection at baseline
The amount of time, measured in seconds, needed by the subject to complete the sit-to-stand transition. At least four trials of the sit-to-stand maneuver were collected for each participant using a motion analysis system. Average and standard deviation of the time to complete the sit-to-stand transition were calculated for each participant (each participant served as their own control in this pilot study). The start of the transition was determined by participant initiation; the end of the transition was determined by the participant reaching full knee extension.
Time to Complete Sit-to-Stand
Time frame: After acclimation to Assist-Knee (Participants are given at least 10 minutes and no more than 60 minutes to acclimate to each Assist-Knee condition for safety. After acclimating, participants will complete the maneuver to measure this outcome.)
The amount of time, measured in seconds, needed by the subject to complete the sit-to-stand transition. At least four trials of the sit-to-stand maneuver were collected for each participant using a motion analysis system. Average and standard deviation of the time to complete the sit-to-stand transition were calculated for each participant (each participant served as their own control in this pilot study). The start of the transition was determined by participant initiation; the end of the transition was determined by the participant reaching full knee extension.
6 secondary outcomes
Timed Up and Go (TUG) Test
Time frame: Collection at baseline
Timed Up and Go (TUG) Test
Time frame: After acclimation to Assist-Knee (Participants are given at least 10 minutes and no more than 60 minutes to acclimate to each Assist-Knee condition for safety. After acclimating, participants will complete the maneuver to measure this outcome.)
Time to Complete Stand-to-Sit
Time frame: Collection at baseline
Time to Complete Stand-to-Sit
Time frame: After acclimation to Assist-Knee (Participants are given at least 10 minutes and no more than 60 minutes to acclimate to each Assist-Knee condition for safety. After acclimating, participants will complete the maneuver to measure this outcome.)
Percentage of Body Weight on Contralateral Limb at 65 Degrees Knee Flexion
Time frame: Collection at baseline
Percentage of Body Weight on Contralateral Limb at 65 Degrees Knee Flexion
Time frame: After acclimation to Assist-Knee (Participants are given at least 10 minutes and no more than 60 minutes to acclimate to each Assist-Knee condition for safety. After acclimating, participants will complete the maneuver to measure this outcome.)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Sarah Chang, PhD principal investigator
Orthocare Innovations, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assist-Knee and Habitual Prosthesis in people with Transfemoral 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 11 inclusion and 6 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: finished, as of the sponsor's last update on 18 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?
Yes. Results are posted in the registry (first posted 7 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time to Complete Sit-to-Stand (time frame: Collection at baseline). 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 18 Oct 2023.