Limb LossNCT05729061
Analysis of Human Movement With Assistive Devices
A study testing Assist-Knee, Prosthetic Knee and Prosthetic Ankle in people with Limb Loss and Limb Weakness, run by Orthocare Innovations, LLC at 1 site in United States.
Trial summary
The purpose of this research is to evaluate how people move about in different settings with different assistive devices or components, and to understand how people interact with different assistive technologies. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Limb Loss, Limb Weakness, Limb Paralysis
- What is being tested?
- Assist-Knee, Prosthetic Knee and Prosthetic Ankle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2022to 28 Nov 2024
- Phase
- Interventional
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 - 90 years
- Has bilateral normal range of motion
- Able to perform a variety of movement activities
- Able to communicate and write individual perceptions in English
- Able to provide written informed consent
- Participants that will use a treadmill during data collection must also be able to walk independently and safely on a treadmill
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- Age 18 - 90 years
- Has a condition or diagnosis that results in limb weakness, limb paralysis, limb loss, or movement disorders
- Medically stable
- Has stable balance
- Able to perform a variety of movement activities
- Able to communicate and write individual perceptions in English
- Able to provide written informed consent
- Participants that will use a treadmill during data collection must also be able to walk independently and safely on a treadmill
- Able to safely complete the movements being tested and/or safely use the assistive devices being tested
Who cannot join
- Health issues (e.g., confounding injury, musculoskeletal, or cognitive) or other issues (e.g., transportation or schedule issues) that limit effective participation and/or may not represent a nondisabled condition
- Pregnancy
- Not able to read and understand English
- Health issues (e.g., confounding injury, musculoskeletal, or cognitive) or other issues (e.g., transportation or schedule issues) that limit effective participation and/or may result in mixed effects of multiple sources of disability
- Pregnancy
- Not able to read and understand English
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
Orthocare Innovations, LLC
Edmonds, Washington, 98020
Adam Arabian, PhD, 425-771-0797, arabian@orthocareinnovations.com
About this study
The purpose of this research is to evaluate how people move about in different settings with different assistive devices or components, and to understand how people interact with different assistive technologies. Individuals that have limb weakness, limb paralysis, limb loss, and movement disorders are often provided assistive devices such as prostheses and orthoses to assist with mobility or use assistive technologies for purposes such as to regain muscle strength or retrain movements. It is important to understand the impact of these different assistive technologies on human movement for technology improvement and in preparation for commercialization.
Because this research focuses on evaluating how different people move about in different settings with different assistive devices/components, there are different activities that may take place. These activities have been classified as (1) Movement Analysis in the Laboratory, (2) Movement Analysis Outside the Laboratory, (3) Usability Testing, and (4) Focus Groups. Each participant may or may not complete the same activities as the other participants. Each participant may or may not complete all of the activities. Participants may complete the activities more than once.
- Conditions
- Limb Loss, Limb Weakness, Limb Paralysis, Movement Disorders
- Being tested
- Assist-Knee, Prosthetic Knee, Prosthetic Ankle, Prosthetic Foot, Ankle-Foot Orthosis
- Medical subject headings
- Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assist-KneeDevice
Investigational prosthetic knee-ankle device
Prosthetic KneeDevice
Commercially available prosthetic knee devices
Prosthetic AnkleDevice
Commercially available prosthetic ankle devices
Prosthetic FootDevice
Commercially available prosthetic foot devices
Ankle-Foot OrthosisDevice
Commercially available ankle-foot orthosis devices
| Study group | Role | What they receive |
|---|---|---|
| Participant with normal assistive device | No intervention | Normal assistive device refers to the habitual assistive device that may be prescribed by a provider of care or no assistive device if the individual does not normally use. |
| Participant with intervention | Other | Intervention refers to investigational assistive devices or commercially available assistive devices that individuals may use during this study. Receives: Device: Assist-Knee; Device: Prosthetic Knee; Device: Prosthetic Ankle; Device: Prosthetic Foot; Device: Ankle-Foot Orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking Speed with no intervention
Walking speed determined over 8 meters of walking
Measured: Collection at baseline
Walking Speed with intervention
Walking speed calculated over 8 meters of walking
Measured: Collection immediately after acclimation with intervention
Secondary outcomes (4)
Time to Complete Sit-to-Stand with no intervention
The amount of time, measured in seconds, needed by the subject to complete the sit-to-stand transition. At least three trials of the sit-to-stand maneuver are collected for each participant using a motion analysis system. Average and standard deviation of the time to complete the sit-to-stand transition are calculated for each participant. The start of the transition will be determined by participant initiation; the end of the transition will be determined by the participant reaching full knee extension.
Measured: Collection at baseline
Time to Complete Sit-to-Stand with intervention
The amount of time, measured in seconds, needed by the subject to complete the sit-to-stand transition. At least three trials of the sit-to-stand maneuver are collected for each participant using a motion analysis system. Average and standard deviation of the time to complete the sit-to-stand transition are calculated for each participant. The start of the transition will be determined by participant initiation; the end of the transition will be determined by the participant reaching full knee extension.
Measured: Collection immediately after acclimation with intervention
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 will complete the TUG test for three trials. Time is measured using a stopwatch. Average and standard deviation of the time to complete the TUG test are calculated for each participant.
Measured: Collection at baseline
Timed Up and Go (TUG) Test with intervention
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 will complete the TUG test for three trials. Time is measured using a stopwatch. Average and standard deviation of the time to complete the TUG test are calculated for each participant.
Measured: Collected immediately after acclimation with intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start28 Nov 2022
- Primary completion28 Nov 2024 (estimated)
- Study completion28 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limb LossStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
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
- Adam Arabian, PhD, Principal investigator, Orthocare Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729061
- Sponsor's protocol ID
- AD-001
- Other IDs
- R44HD097826
- Status last verified
- Oct 2023
- First submitted
- 5 Jan 2023
- Last updated
- 10 Oct 2023
- Results posted
- 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
- Analysis of Human Movement With Assistive Devices
- ClinicalTrials.gov ID
- NCT05729061
- Acronym / sponsor ID
- AD-001
- Conditions
- Limb Loss, Limb Weakness, Limb Paralysis, Movement Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Orthocare Innovations, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 28 Nov 2024 (estimated)
- Study completion
- 28 Nov 2024 (estimated)
- First posted
- 15 Feb 2023 (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 evaluate how people move about in different settings with different assistive devices or components, and to understand how people interact with different assistive technologies. Individuals that have limb weakness, limb paralysis, limb loss, and movement disorders are often provided assistive devices such as prostheses and orthoses to assist with mobility or use assistive technologies for purposes such as to regain muscle strength or retrain movements. It is important to understand the impact of these different assistive technologies on human movement for technology improvement and in preparation for commercialization.
Because this research focuses on evaluating how different people move about in different settings with different assistive devices/components, there are different activities that may take place. These activities have been classified as (1) Movement Analysis in the Laboratory, (2) Movement Analysis Outside the Laboratory, (3) Usability Testing, and (4) Focus Groups. Each participant may or may not complete the same activities as the other participants. Each participant may or may not complete all of the activities. Participants may complete the activities more than once.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participant with normal assistive device | No intervention | –Normal assistive device refers to the habitual assistive device that may be prescribed by a provider of care or no assistive device if the individual does not normally use. |
| Participant with intervention | Other | Device: Assist-Knee, Device: Prosthetic Knee, Device: Prosthetic Ankle, Device: Prosthetic Foot, Device: Ankle-Foot OrthosisIntervention refers to investigational assistive devices or commercially available assistive devices that individuals may use during this study. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age 18 - 90 years
- Has bilateral normal range of motion
- Able to perform a variety of movement activities
- Able to communicate and write individual perceptions in English
- Able to provide written informed consent
Key exclusion criteria (6 listed)
- Health issues (e.g., confounding injury, musculoskeletal, or cognitive) or other issues (e.g., transportation or schedule issues) that limit effective participation and/or may not represent a nondisabled condition
- Pregnancy
- Not able to read and understand English
- Health issues (e.g., confounding injury, musculoskeletal, or cognitive) or other issues (e.g., transportation or schedule issues) that limit effective participation and/or may result in mixed effects of multiple sources of disability
- Pregnancy
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-KneeInvestigational prosthetic knee-ankle device | Device | Participant with intervention |
| Prosthetic KneeCommercially available prosthetic knee devices | Device | Participant with intervention |
| Prosthetic AnkleCommercially available prosthetic ankle devices | Device | Participant with intervention |
| Prosthetic FootCommercially available prosthetic foot devices | Device | Participant with intervention |
| Ankle-Foot OrthosisCommercially available ankle-foot orthosis devices | Device | Participant with intervention |
Primary outcome
Walking Speed with no intervention
Time frame: Collection at baseline
Walking speed determined over 8 meters of walking
Walking Speed with intervention
Time frame: Collection immediately after acclimation with intervention
Walking speed calculated over 8 meters of walking
4 secondary outcomes
Time to Complete Sit-to-Stand with no intervention
Time frame: Collection at baseline
Time to Complete Sit-to-Stand with intervention
Time frame: Collection immediately after acclimation with intervention
Timed Up and Go (TUG) Test
Time frame: Collection at baseline
Timed Up and Go (TUG) Test with intervention
Time frame: Collected immediately after acclimation with intervention
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 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.
Adam Arabian, 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, Prosthetic Knee and Prosthetic Ankle in people with Limb Loss and Limb Weakness, 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 15 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: looking for participants now, 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?
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 Adam Arabian, PhD (425-771-0797, arabian@orthocareinnovations.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking Speed with no intervention (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 10 Oct 2023.