AmputationNCT04038151
Intuitive Control of a Hybrid Prosthetic Leg During Ambulation
A study testing Hybrid Leg and Prescribed Passive Prosthesis in people with Amputation, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
The objective of this research is to determine the clinical benefits of an innovative and lightweight powered leg controlled using our intent recognition framework in laboratory and community environments. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Amputation
- What is being tested?
- Hybrid Leg and Prescribed Passive Prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2018to 30 Jun 2025
- 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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A unilateral or bilateral lower limb amputation
- K2/K3/K4 ambulator with a prosthesis
- English speaking
Who cannot join
- Significant new injury that would prevent use of a prosthesis: The ability to consistently wear a prosthesis and perform activities of daily living and specific performance tasks is necessary to evaluate the relative benefits of the interventions.
- Cognitive impairment sufficient to adversely affect understanding of or compliance with study requirements, ability to communicate experiences, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential in order for the study to generate useable, reliable data. The ability to obtain relevant user feedback through questionnaires and informal discussion adds significant value to this study.
- Significant other comorbidity: Any other medical issues or injuries that would preclude completion of the study, use of the prostheses, or that would otherwise prevent acquisition of useable data by researchers.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Shirley Ryan AbilityLab
Chicago, Illinois, 60611
Suzanne Finucane, 312-238-0937, sfinucane@sralab.org
Levi Hargrove, PhD
About this study
The objective of this research is to determine the clinical benefits of an innovative and lightweight powered leg controlled using our intent recognition framework in laboratory and community environments.
Read the detailed description
The hypothesis of this study is that using the Hybrid Leg with seamless, automatic transitions will result in participants choosing to become more active and improve their community participation compared to when using their own passive prosthetic leg.
The Hybrid Leg is an an innovative and lightweight powered leg that has 2 operating modes: active and passive. When in active mode, the Hybrid Leg is capable of supplying 120 NM of knee torque and actively repositioning the ankle during non-weight bearing phases of gait. When in passive mode, the motor and transmission are decoupled from the knee, which then behaves like an Ottobock 3R95 passive prosthetic knee, and the non-backdriveable mechanism of the ankle allows it to behave as an energy return foot. Allowing the device to behave passively if the battery becomes depleted or the actuators become damaged is an important enabling safety factor that will allow us to complete our study.
Phase 1: We will enroll 20 subjects a clinical trial of the leg and control system who will be fit with the Hybrid Leg and receive in-lab therapy to learn how to ambulate with the device.
Phase 2: Subjects will be randomized into a clinical trial of the leg and control system with an AB-BA design; condition A - subjects own device; condition B - Hybrid Leg. Subjects will complete an extensive ambulation and community mobility training to learn optimal use of their own passive device or the Hybrid Leg. After training the subjects will complete a full biomechanical analysis for each device as they complete ambulation circuits that include standing, level-ground walking, walking on slopes and on stairs, sit-stand transitions and transitions between these activities.
Phase 3: After completing phase 2 subjects will complete 4-week trials using their assigned prosthesis (Condition A or B) at home and within their community. During the trials subjects will be monitored using mobile phone based sensors and socket mounted activity monitor to determine how often the user performs the ambulation activities.
- Conditions
- Amputation
- Being tested
- Hybrid Leg, Prescribed Passive Prosthesis
- Keywords
- Transfemoral Amputation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid LegDevice
The Hybrid Knee uses an actively variable transmission in combination of a passive spring/damper system. This allows the motor torque output to be adapted to the requirements of active dynamic tasks - changing the effective transmission ration from zero (fully passive) for level ground walking to a maximum value (fully active) for sit-to-stand transfers. This provides physiological knee torque and speed with a small motor and primary transmission system while also maximizing electrical efficiency, which minimized battery weight. The knee prototype weights 1.7kg. The Semi-active ankle can actively reposition during non-weight bearing phases of gait and uses a non back driveable transmission to maintain its set point during weight bearing activities.
Prescribed Passive ProsthesisDevice
Participants will participate in training sessions of community skills and advanced ambulation training for their home, prescribed passive prosthesis.
| Study group | Role | What they receive |
|---|---|---|
| Condition A: Hybrid Leg | Experimental | Subject will be trained on use of the experimental device, the Hybrid Leg. Receives: Device: Hybrid Leg |
| Condition B: Passive Leg | Other | Subject will use their currently prescribed home passive prosthesis Receives: Device: Prescribed Passive Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average daily number of steps
This outcome will be assessed using an accelerometery data measured using a mobile phone during the entire 4-week home trial of each device (Hybrid Leg and prescribed home device), resulting in a pair of outcomes for each subject. Statistical analysis will be done , first using a paired t-test (which assumes no carry-over and no device sequence effects), followed by the analysis using a linear mixed model with device and sequence group as fixed effects, and subject as the random effect. We expect that sequence will not be a statistically significant predictor, but that average daily steps will be significantly different between devices, with subjects taking significantly more steps when using the Hybrid Leg.
Measured: 4 weeks - data collected during 4 week home trial of each device, analyzed upon completion of 4 week home trial
Average daily number of times subject switches between activities
This outcome will be assessed using an accelerometery data measured using a mobile phone during the entire 4-week home trial of each device (Hybrid Leg and prescribed home device), resulting in a pair of outcomes for each subject. Statistical analysis will be done , first using a paired t-test (which assumes no carry-over and no device sequence effects), followed by the analysis using a linear mixed model with device and sequence group as fixed effects, and subject as the random effect. We expect that sequence will not be a statistically significant predictor, but that average transitions will be significantly different between devices, with subjects taking significantly more transitioning between activities more when using the Hybrid Leg.
Measured: 4 weeks - data collected during 4 week home trial of each device, analyzed upon completion of 4 week home trial
Secondary outcomes (10)
10 Meter Walk Test
The 10mWT is used to assess walking speed in meters/second (m/s) over a short distance.
Measured: Lab visit prior to start of home trial and lab visit upon completion of 4 week trial with each device
GPS tracking analysis
Subject-specific map of movement within the community will be generated and investigated for individual changes in community mobility and cross-referenced with their survey results. These data could provide insight into how well patient-reported measures reflect actual community participation, although this possibility is acknowledged to be exploratory
Measured: End of each 4 week home trial
Six-Minute Walk Test
The 6MWT is a sub-maximal exercise test used to assess walking endurance and aerobic capacity. Participants will walk around the perimeter of a set circuit for a total of six minutes.
Measured: Lab visit prior to start of home trial and lab visit upon completion of 4 week trial with each device
Hill Assessment Index
The Hill Assessment Index (HAI) is a 12 level ordinal scale developed to address different characteristics of hill ascent and descent in preparation comparing different prosthetic knee units. The HAI assesses gait patterns on hills combined with assistive device usage reflecting the quality of independence.
Measured: Lab visit prior to start of home trial and lab visit upon completion of 4 week trial with each device
Stair Assessment Index
The Stair Assessment Index is a 14 level ordinal scale that assesses the functional ability of transfemoral amputees for stair ascent and descent. It is being used as a physical measurement tool to document different gait styles on the stairs.
Measured: Lab visit prior to start of home trial and lab visit upon completion of 4 week trial with each device
Berg Balance Scale
The Berg Balance Scale is a 14 item objective measure that assesses static balance and fall risk in adults.
Measured: Lab visit prior to start of home trial and lab visit upon completion of 4 week trial with each device
Functional Gait Assessment
The FGA is used to assess postural stability during walking and assesses an individual's ability to perform multiple motor tasks while walking. The tool is a modification of the 8-item Dynamic Gait Index, developed to improve reliability and reduce ceiling effect.
Measured: Lab visit prior to start of home trial and lab visit upon completion of 4 week trial with each device
5 Times Sit to Stand
The Five Times Sit to Stand Test measures one aspect of transfer skill. The test provides a method of quantify functional lower extremity strength and /or identify movement strategies a patient used to complete transitional movements.
Measured: Lab visit prior to start of home trial and lab visit upon completion of 4 week trial with each device
4 -Square Step Test
Test of dynamic balance that clinically assesses the person's ability to step over objects forward, sideways, and backwards.
Measured: Lab visit prior to start of home trial and lab visit upon completion of 4 week trial with each device
Amputee Mobility Predictor
This instrument measures the ambulatory potential of lower limb amputees with and without the use of a prosthesis. It assesses the mobility of people with lower limb amputation prior to prosthetic fitting and predicts function following prosthetic prescription.
Measured: Lab visit prior to start of home trial and lab visit upon completion of 4 week trial with each device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start1 Dec 2018
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Levi Hargrove, Shirley Ryan AbilityLab
- Investigators
- Levi Hargrove, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04038151
- Sponsor's protocol ID
- STU00209522
- Other IDs
- 2R01HD079428-05
- Status last verified
- May 2024
- First submitted
- 19 Jul 2019
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be made available
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intuitive Control of a Hybrid Prosthetic Leg During Ambulation
- ClinicalTrials.gov ID
- NCT04038151
- Acronym / sponsor ID
- STU00209522
- Conditions
- Amputation
- Keywords
- Transfemoral Amputation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 30 Jul 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 objective of this research is to determine the clinical benefits of an innovative and lightweight powered leg controlled using our intent recognition framework in laboratory and community environments.
Detailed description
The hypothesis of this study is that using the Hybrid Leg with seamless, automatic transitions will result in participants choosing to become more active and improve their community participation compared to when using their own passive prosthetic leg.
The Hybrid Leg is an an innovative and lightweight powered leg that has 2 operating modes: active and passive. When in active mode, the Hybrid Leg is capable of supplying 120 NM of knee torque and actively repositioning the ankle during non-weight bearing phases of gait. When in passive mode, the motor and transmission are decoupled from the knee, which then behaves like an Ottobock 3R95 passive prosthetic knee, and the non-backdriveable mechanism of the ankle allows it to behave as an energy return foot. Allowing the device to behave passively if the battery becomes depleted or the actuators become damaged is an important enabling safety factor that will allow us to complete our study.
Phase 1: We will enroll 20 subjects a clinical trial of the leg and control system who will be fit with the Hybrid Leg and receive in-lab therapy to learn how to ambulate with the device.
Phase 2: Subjects will be randomized into a clinical trial of the leg and control system with an AB-BA design; condition A - subjects own device; condition B - Hybrid Leg. Subjects will complete an extensive ambulation and community mobility training to learn optimal use of their own passive device or the Hybrid Leg. After training the subjects will complete a full biomechanical analysis for each device as they complete ambulation circuits that include standing, level-ground walking, walking on slopes and on stairs, sit-stand transitions and transitions between these activities.
Phase 3: After completing phase 2 subjects will complete 4-week trials using their assigned prosthesis (Condition A or B) at home and within their community. During the trials subjects will be monitored using mobile phone based sensors and socket mounted activity monitor to determine how often the user performs the ambulation activities.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Condition A: Hybrid Leg | Experimental | Device: Hybrid LegSubject will be trained on use of the experimental device, the Hybrid Leg. |
| Condition B: Passive Leg | Other | Device: Prescribed Passive ProsthesisSubject will use their currently prescribed home passive prosthesis |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A unilateral or bilateral lower limb amputation
- K2/K3/K4 ambulator with a prosthesis
- English speaking
Key exclusion criteria (3 listed)
- Significant new injury that would prevent use of a prosthesis: The ability to consistently wear a prosthesis and perform activities of daily living and specific performance tasks is necessary to evaluate the relative benefits of the interventions.
- Cognitive impairment sufficient to adversely affect understanding of or compliance with study requirements, ability to communicate experiences, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential in order for the study to generate useable, reliable data. The ability to obtain relevant user feedback through questionnaires and informal discussion adds significant value to this study.
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 |
|---|---|---|
| Hybrid LegThe Hybrid Knee uses an actively variable transmission in combination of a passive spring/damper system. This allows the motor torque output to be adapted to the requirements of active dynamic tasks - changing the effective transmission ration from zero (fully passive) for level ground walking to a maximum value (fully active) for sit-to-stand transfers. This provides physiological knee torque and speed with a small motor and primary transmission system while also maximizing electrical efficiency, which minimized battery weight. The knee prototype weights 1.7kg. The Semi-active ankle can actively reposition during non-weight bearing phases of gait and uses a non back driveable transmission to maintain its set point during weight bearing activities. | Device | Condition A: Hybrid Leg |
| Prescribed Passive ProsthesisParticipants will participate in training sessions of community skills and advanced ambulation training for their home, prescribed passive prosthesis. | Device | Condition B: Passive Leg |
Primary outcome
Average daily number of steps
Time frame: 4 weeks - data collected during 4 week home trial of each device, analyzed upon completion of 4 week home trial
This outcome will be assessed using an accelerometery data measured using a mobile phone during the entire 4-week home trial of each device (Hybrid Leg and prescribed home device), resulting in a pair of outcomes for each subject. Statistical analysis will be done , first using a paired t-test (which assumes no carry-over and no device sequence effects), followed by the analysis using a linear mixed model with device and sequence group as fixed effects, and subject as the random effect. We expect that sequence will not be a statistically significant predictor, but that average daily steps will be significantly different between devices, with subjects taking significantly more steps when using the Hybrid Leg.
Average daily number of times subject switches between activities
Time frame: 4 weeks - data collected during 4 week home trial of each device, analyzed upon completion of 4 week home trial
This outcome will be assessed using an accelerometery data measured using a mobile phone during the entire 4-week home trial of each device (Hybrid Leg and prescribed home device), resulting in a pair of outcomes for each subject. Statistical analysis will be done , first using a paired t-test (which assumes no carry-over and no device sequence effects), followed by the analysis using a linear mixed model with device and sequence group as fixed effects, and subject as the random effect. We expect that sequence will not be a statistically significant predictor, but that average transitions will be significantly different between devices, with subjects taking significantly more transitioning between activities more when using the Hybrid Leg.
10 secondary outcomes
10 Meter Walk Test
Time frame: Lab visit prior to start of home trial and lab visit upon completion of 4 week trial with each device
GPS tracking analysis
Time frame: End of each 4 week home trial
Six-Minute Walk Test
Time frame: Lab visit prior to start of home trial and lab visit upon completion of 4 week trial with each device
Hill Assessment Index
Time frame: Lab visit prior to start of home trial and lab visit upon completion of 4 week trial with each device
Stair Assessment Index
Time frame: Lab visit prior to start of home trial and lab visit upon completion of 4 week trial with each device
Berg Balance Scale
Time frame: Lab visit prior to start of home trial and lab visit upon completion of 4 week trial with each device
Functional Gait Assessment
Time frame: Lab visit prior to start of home trial and lab visit upon completion of 4 week trial with each device
5 Times Sit to Stand
Time frame: Lab visit prior to start of home trial and lab visit upon completion of 4 week trial with each device
4 -Square Step Test
Time frame: Lab visit prior to start of home trial and lab visit upon completion of 4 week trial with each device
Amputee Mobility Predictor
Time frame: Lab visit prior to start of home trial and lab visit upon completion of 4 week trial with each device
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be made available
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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.
Levi Hargrove, PhD principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid Leg and Prescribed Passive Prosthesis in people with Amputation, run by Shirley Ryan AbilityLab 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 17 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suzanne Finucane (312-238-0937, sfinucane@sralab.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average daily number of steps (time frame: 4 weeks - data collected during 4 week home trial of each device, analyzed upon completion of 4 week home trial). 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 17 May 2024.