Unilateral Traumatic AmputationNCT02828982
Determining the Potential Benefit of Powered Prostheses
A study testing Powered ankle prosthesis and Dynamic Response Foot in people with Unilateral Traumatic Amputation and Amputation, Traumatic, run by Deanna H Gates at 1 site in United States.
Trial summary
The goal of this research is to determine the effectiveness of a powered prosthesis compared to an unpowered prosthesis during short bouts of walking, extended periods of walking (to fatigue), and performance in the community. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Unilateral Traumatic Amputation, Amputation, Traumatic
- What is being tested?
- Powered ankle prosthesis and Dynamic Response Foot
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Aug 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (over 21 years old), Has unilateral transtibial amputation, has used prosthesis for at least 6 months, is currently using an unpowered prosthesis, can walk unassisted for at least 10 minutes
Who cannot join
- History of orthopedic or neurologic disorders to their intact limb, history of cardiovascular disease that prevents them from safely completing requested activities, unable to walk for 30 minutes at a time
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this research is to determine the effectiveness of a powered prosthesis compared to an unpowered prosthesis during short bouts of walking, extended periods of walking (to fatigue), and performance in the community.
Read the detailed description
Many individuals are living in the United States with limb loss. With the use of a prosthetic device many individuals can stay active, but most do not achieve a medically desired physical activity level. This creates a risk for cardiovascular disease. It is thought that individuals with amputation walk less because it is more difficult to get around, and recent advances in robotic prosthetic technology may make such activities easier. However, these prostheses have not yet been evaluated to determine their effectiveness during extended periods of walking. Despite the goals in design of new devices it is unclear whether individuals using them are able to incorporate them into making daily activities easier. Therefore, the goal of this research is to determine the effectiveness of a powered prosthesis compared to an unpowered prosthesis during long periods of walking.
- Being tested
- Powered ankle prosthesis, Dynamic Response Foot
- Keywords
- powered ankle prosthesis, activity monitoring, muscle fatigue, below knee amputation
- Medical subject headings
- Amputation, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Powered ankle prosthesisDevice
This device is a commercially available powered ankle prosthesis, (BioM, Bionx, Bedford, MA) which was given FDA device exempt status.
Dynamic Response FootDevice
This condition is a sham condition as the participant will wear the prosthesis they were clinically prescribed and usually wear.
| Study group | Role | What they receive |
|---|---|---|
| Powered Ankle Prosthesis | Experimental | In this condition, the participant is fitted with a powered prosthetic ankle by a certified prosthetist. The ankle is the BiOM which is manufactured by Bionx (which used to be named iWalk). This device was given 510(K) Exempt status by the FDA under (regulation number: 890.3500). Participants will wear the device for 2 weeks. Receives: Device: Powered ankle prosthesis |
| Dynamic Response Foot | Sham comparator | In this arm, participants will wear their clinically prescribed dynamic response foot. This period is 2 weeks long. Receives: Device: Dynamic Response Foot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic Cost of Walking
Metabolic costs will be measured using a portable metabolic system when participants walk on a treadmill at a fixed speed.
Measured: Testing took place after wearing the prostheses for two weeks
Total Steps Outside the Home Over a Two Week Period
Activity data we be collected using activity monitors and GPS with both the regular prosthesis and the powered ankle prosthesis. Each activity monitoring period will last 2 weeks and will be done within in a 2 month period. Daily step count taken outside of the home, determined using an activity monitor and GPS device
Measured: 2 weeks
Quality of Life (QoL) on a Short-Form 36
Participants completed the Medical Outcomes Study 36 Items Short-Form Health Survey (SF-36) after each condition. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Measured: Questionnaire completed 2 weeks after wearing each prosthesis
Secondary outcomes (3)
Prosthetic Evaluation Questionnaire (PEQ)
Participants completed a survey to evaluate their prosthetic satisfaction (Prosthetic Evaluation Questionnaire) after each condition. Most questions in the PEQ use a visual analog scale format. Each visual analog scale is scored as a continuous numerical variable measured as the distance in millimeters from the left endpoint of the line (0 mm) to the point at which the respondent's mark crosses the line (up to 100 mm). The questions are all worded so that a higher number (toward the right) will correspond with a more positive response.
Ambulation - Greater number = increased perceived ambulation Appearance - Greater number = better appearance Frustration - Greater number = less frustration Perceived Response - Greater number = increased perceived response Residual Limb Health - Greater number = better residual limb health Social burden - Greater number = less social burden Sounds - Greater number = less sound Utility - Greater
Measured: Questionnaire completed 2 weeks after wearing each prosthesis
Muscle Activity in the Lower Limb
Participants walk on a treadmill while muscle activity from various lower limb muscles are monitored using electromyography. We calculated the integrated EMG (iEMG) for each muscle collected as the total activity in that muscle as a percentage of the maximum signal.
Measured: Testing took place after the participant wore the prosthesis for 2 weeks
Time to Fatigue
Participants walk on a treadmill at a fast speed until they felt they can no longer continue. The time to fatigue was recorded.
Measured: Testing took place after wearing the prostheses for two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionAug 2019
- Study completionAug 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unilateral Traumatic 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deanna H Gates
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Deanna H Gates, University of Michigan
- Investigators
- Deanna H Gates, Ph.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828982
- Sponsor's protocol ID
- HUM00080734
- Status last verified
- Jan 2022
- First submitted
- 29 Jun 2016
- Last updated
- 18 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kim J, Wensman J, Colabianchi N, Gates DH. The influence of powered prostheses on user perspectives, metabolics, and activity: a randomized crossover trial. J Neuroeng Rehabil. 2021 Mar 16;18(1):49. doi: 10.1186/s12984-021-00842-2.
PubMed 33726802
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Potential Benefit of Powered Prostheses
- ClinicalTrials.gov ID
- NCT02828982
- Acronym / sponsor ID
- HUM00080734
- Keywords
- powered ankle prosthesis, activity monitoring, muscle fatigue, below knee amputation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Deanna H GatesUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Posted 13 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this research is to determine the effectiveness of a powered prosthesis compared to an unpowered prosthesis during short bouts of walking, extended periods of walking (to fatigue), and performance in the community.
Detailed description
Many individuals are living in the United States with limb loss. With the use of a prosthetic device many individuals can stay active, but most do not achieve a medically desired physical activity level. This creates a risk for cardiovascular disease. It is thought that individuals with amputation walk less because it is more difficult to get around, and recent advances in robotic prosthetic technology may make such activities easier. However, these prostheses have not yet been evaluated to determine their effectiveness during extended periods of walking. Despite the goals in design of new devices it is unclear whether individuals using them are able to incorporate them into making daily activities easier. Therefore, the goal of this research is to determine the effectiveness of a powered prosthesis compared to an unpowered prosthesis during long periods of walking.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Powered Ankle Prosthesis | Experimental | Device: Powered ankle prosthesisIn this condition, the participant is fitted with a powered prosthetic ankle by a certified prosthetist. The ankle is the BiOM which is manufactured by Bionx (which used to be named iWalk). This device was given 510(K) Exempt status by the FDA under (regulation number: 890.3500). Participants will wear the device for 2 weeks. |
| Dynamic Response Foot | Sham comparator | Device: Dynamic Response FootIn this arm, participants will wear their clinically prescribed dynamic response foot. This period is 2 weeks long. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult (over 21 years old), Has unilateral transtibial amputation, has used prosthesis for at least 6 months, is currently using an unpowered prosthesis, can walk unassisted for at least 10 minutes
Key exclusion criteria (1 listed)
- History of orthopedic or neurologic disorders to their intact limb, history of cardiovascular disease that prevents them from safely completing requested activities, unable to walk for 30 minutes at a time
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 |
|---|---|---|
| Powered ankle prosthesisThis device is a commercially available powered ankle prosthesis, (BioM, Bionx, Bedford, MA) which was given FDA device exempt status. | Device | Powered Ankle Prosthesis |
| Dynamic Response FootThis condition is a sham condition as the participant will wear the prosthesis they were clinically prescribed and usually wear. | Device | Dynamic Response Foot |
Primary outcome
Metabolic Cost of Walking
Time frame: Testing took place after wearing the prostheses for two weeks
Metabolic costs will be measured using a portable metabolic system when participants walk on a treadmill at a fixed speed.
Total Steps Outside the Home Over a Two Week Period
Time frame: 2 weeks
Activity data we be collected using activity monitors and GPS with both the regular prosthesis and the powered ankle prosthesis. Each activity monitoring period will last 2 weeks and will be done within in a 2 month period. Daily step count taken outside of the home, determined using an activity monitor and GPS device
Quality of Life (QoL) on a Short-Form 36
Time frame: Questionnaire completed 2 weeks after wearing each prosthesis
Participants completed the Medical Outcomes Study 36 Items Short-Form Health Survey (SF-36) after each condition. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
3 secondary outcomes
Prosthetic Evaluation Questionnaire (PEQ)
Time frame: Questionnaire completed 2 weeks after wearing each prosthesis
Muscle Activity in the Lower Limb
Time frame: Testing took place after the participant wore the prosthesis for 2 weeks
Time to Fatigue
Time frame: Testing took place after wearing the prostheses for two weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33726802Kim J, Wensman J, Colabianchi N, Gates DH. The influence of powered prostheses on user perspectives, metabolics, and activity: a randomized crossover trial. J Neuroeng Rehabil. 2021 Mar 16;18(1):49. doi: 10.1186/s12984-021-00842-2.
- Individual participant dataSharing planned: No
Related trials for Unilateral Traumatic Amputation
Recruiting
REsistance and LOADing Exercise for Bone Health
Amputation of Lower Limb Below Knee, Amputation, Traumatic
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.
Deanna H Gates, Ph.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Powered ankle prosthesis and Dynamic Response Foot in people with Unilateral Traumatic Amputation and Amputation, Traumatic, run by Deanna H Gates 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 1 inclusion and 1 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 Jan 2022. 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. Some participants in this study may receive a placebo. 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 13 Nov 2020). 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?
Metabolic Cost of Walking (time frame: Testing took place after wearing the prostheses for two weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02828982, which also lists 1 linked publication.
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 Jan 2022.