Prostheses and ImplantsNCT04197011
Advanced Prosthetic Devices for Lower Limb Amputees
An observational study of Prostheses and Implants, run by Nottingham Trent University at 1 site in United Kingdom.
Trial summary
Lower limb amputation is an emerging global health concern. Currently, there are over 1.6 million amputees in the U.S. and around 6000 new amputations are recorded per annum in the UK. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prostheses and Implants
- What is being tested?
- prosthetic device
- Type of treatment
- Medical device
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Feb 2019to 1 Oct 2022
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study aims to recruit two groups of participants, one group of individuals with unilateral transfemoral amputation (TFA) and a group of otherwise healthy control participants (CRTL). Both groups are required to satisfy inclusion and exclusion criteria and provide written informed consent in order to participate.
Who may be able to join
- Transfemoral amputation: Individuals who have had unilateral transfemoral amputation.
- Demographics: Adult, community-dwelling individuals above the age of 18 in order to provide written informed consent for themselves.
- Mental Capacity: Ability to comprehend and understand communication and instruction in English in order to consent and safely participate in study as assessed verbally.
- Mobility level: Prospective participants must be able to negotiate obstacles such as ramps and stairs thus displaying a level of mobility commensurate with a medicare K3 functional classification level.
- Endurance Capacity: Able to walk continuously for periods of up to two minutes at a time in order to complete the clinical walking tests.
- Vision: Good (corrected) vision to safely walk in well-lit areas.
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- Cardiovascular Health: No self-reported unresolved cardiovascular complaints to avoid any cardiovascular complications when performing activities of daily living.
- Able to travel: Data collection will take place at Nottingham Trent University, Clifton Campus.
- For the otherwise healthy control (CTRL) group, the same criteria apply, with the exception of those pertaining specifically to amputation status.
Who cannot join
- Pain: Experience undue musculo-skeletal pain during walking that causes individual to stop and not be able to continue when walking at a self-selected speed.
- Disease/Illness: Unable and/or unsafe to carry out tasks due to disease/illness such as rheumatoid arthritis.
- Injury: Current neuromuscular, musculoskeletal injury.
- Falls: Falls regularly (>1 a month) as determined using the PROFANE fall definition. Excludes recreational, sporting or occupational falls outside of this definition.
- Residuum health: Presence of significant blisters, wounds and rash which prevent prosthesis, sock and liner to be worn comfortably.
- Residuum stability: Observing substantial changes to the physical condition of the lower limb that requires medical attention as judged by the participant, and if after consenting and participating in the study, individuals are referred to mobility services due to a degradation of the physical condition of either lower limb.
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- Unable to follow instruction or cognitive deficits: Risk of further injury whilst completing tasks incorrectly.
- Not able to understand written and verbal English: All communication will be in English as the University does not provide translation services.
- For the otherwise healthy control (CTRL) group, the same criteria apply, with the exception of those pertaining specifically to amputation status.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Biomechanics Lab, CELS Building, Nottingham Trent University
Nottingham, Notts, NG11 8NS
About this study
Official title: Investigating the Effects of Micro-processor Controlled Knee Components on the Function and Performance of Individuals With Transfemoral Amputation
Lower limb amputation is an emerging global health concern. Currently, there are over 1.6 million amputees in the U.S. and around 6000 new amputations are recorded per annum in the UK. These numbers are expected to double by 2050 due to the increasing aging population and the adverse health issues such as diabetes, representing a significant, growing problem in western society. A lower limb amputation results in the loss of the biological joint structures such as the ankle and knee, along with the associated musculature. In order to overcome these physical losses, many lower limb amputees are provided with a prosthetic limb that enable them to participate in activities of daily living. The design and function of these prosthetic limbs varies widely, with some being very basic, non-articulating, semi-rigid structures while other more advanced components are computer controlled or incorporate robotic function. Lower limb amputees have been shown to fall more often when compared to age matched individuals without lower limb amputation. This has been reported to be partly a result of a less stable walking pattern. Given that the prosthetic limb provided and it's functional capability is a large component of how well a lower limb amputee is able to walk, it is important to understand what the effects of and potential benefits are from using more advanced prosthetic devices, such as micro-processor controlled knee joints and articulating ankle joints.
Therefore, the aim of the current study is to investigate the effects of combining more advanced prosthetic ankle-foot and knee components on the biomechanics of activities of daily living in individuals with above knee amputation.
Read the detailed description
Study Background Lower limb amputation is an emerging global health concern. Currently, there are over 1.6 million amputees in the U.S. and around 6000 new amputations are recorded per annum in the UK. These numbers are expected to double by 2050 due to the increasing aging population and the adverse health issues such as diabetes, representing a significant, growing problem in western society. A lower limb amputation results in the loss of the biological joint structures such as the ankle and knee, along with the associated musculature. In order to overcome these physical losses, many lower limb amputees are provided with a prosthetic limb that enable them to participate in activities of daily living. The design and function of these prosthetic limbs varies widely, with some being very basic non-articulating semi-rigid structures while other more advanced components are computer controlled and function robotically. Advanced ankle components have been shown to provide lower limb amputees with a number of benefits including increased walking speed, improved symmetry between legs and increased forward progression. In addition, micro-processor controlled knee components, recently made available through the NHS via NHS England Clinical commissioning, have shown a number of benefits. These benefits are stated as being '…enhanced stability and stumble recovery, which improves fall management and reduces the incidence of falls. This supports the increases in self-reported improved individual mobility and independence. MPKs also improve controlled sitting and standing, walking gait symmetry, stair decent, controlled step over step descent down a slope, reduced energy expenditure, and given different modes for different activities an ability to manage obstacles more easily'. Given that the prosthetic limb provided and their functional capability is a large component of how well a lower limb amputee is able to walk, it is important to understand what the effects of and potential benefits are from using more advanced prosthetic devices, such as micro-processor controlled knee joints. Also, as these components are used in conjunction with ankle-foot devices, it is important to know what the optimal combination may be to gain the most benefits from both prosthetic components.
Study Aim The aim of the current study is to investigate the effects of combining more advanced prosthetic ankle-foot and knee components on the biomechanics of activities of daily living in individuals with above knee amputation.
- Conditions
- Prostheses and Implants
- Being tested
- prosthetic device
- Keywords
- Prosthetics, Microprocessor, Hydraulic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prosthetic deviceDevice
Individuals with TFA will use a combination of prosthetic devices.
| Study group | Role | What they receive |
|---|---|---|
| Prosthesis users | Individuals with unilateral transfemoral amputation. Receives: Device: prosthetic device | |
| Control | Individuals without unilateral transfemoral amputation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obstacle Course Completion Time (seconds)
The total time taken to complete one lap of a custom walking course in seconds.
Measured: All experimental conditions - up to six weeks
Secondary outcomes (10)
Two-minute walk (2MWT) test (metres)
The total distance walked in two minutes along a 13m walkway.
Measured: All experimental conditions - up to six weeks
The timed up and Go (TUG) test
Assessment of mobility, where participants are timed whilst rising from an arm chair, walking three metres, and returning to a sitting position on the chair
Measured: All experimental conditions - up to six weeks
The L-test
This is a modified version of the TUG test, where individuals rise from a chair, walk three metres, turn 90 degrees, walk seven metres, turn 180 degrees, walk seven metres, turn 90 and return to a sitting position in the same chair.
Measured: All experimental conditions - up to six weeks
Berg Balance Scale
Grading the participants' ability to perform a number of functional tasks such as moving from standing to sitting which are scored on a five point scale from zero (worst) to four (best).
Measured: All experimental conditions - up to six weeks
EQ-5D-5L
Standardised measure of health related quality of life which is used internationally. A visual analogue scale requires participants to rate their health on a zero (worst) to 100 (best) scale.
Measured: All experimental conditions - up to six weeks. Only applicable for participants who are currently trialling an MPK.
Activities Balance Confidence Scale-UK (ABC-UK)
A self-report, quality of life outcome measure, relating balance confidence to functional activities. Scores are reported from zero (worst) to 100 (best) in terms of their confidence in completing a particular task.
Measured: All experimental conditions - up to six weeks. Only applicable for participants who are currently trialling an MPK.
Locomotor Capabilities Index (LCI)
Assessment of self-perceived capability to perform 14 different locomotor activities when using a prosthesis. This is rated on a five point scale from zero (worst) to four (best).
Measured: All experimental conditions - up to six weeks. Only applicable for participants who are currently trialling an MPK.
The Houghton Scale
A 4-item instrument that assesses prosthetic use in and reflects a person's perception of prosthetic use. This is rated on a four point scale from zero (worst) to three (best).
Measured: All experimental conditions - up to six weeks. Only applicable for participants who are currently trialling an MPK.
Custom Falls Report
A recall on the incidence and circumstances around falls experienced which are reported every 30 days.
Measured: All experimental conditions - up to six weeks. Only applicable for participants who are currently trialling an MPK.
The Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form
Taking pain related aspects of this survey to quantify self-reported pain issues in prosthesis users. For example, pain interference when completing a task is rated on a five point scale from 'not at all' (best) to 'very much'.
Measured: All experimental conditions - up to six weeks. Only applicable for participants who are currently trialling an MPK.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start6 Feb 2019
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostheses and ImplantsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham Trent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Cleveland T. Barnett, Nottingham Trent University
- Investigators
- Cleveland Barnett, Ph.D, Principal investigator, Nottingham Trent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197011
- Sponsor's protocol ID
- IRAS237030
- Status last verified
- Oct 2022
- First submitted
- 5 Dec 2019
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Micro-processor Controlled Knee Components on the Function and Performance of Individuals With Transfemoral Amputation
- ClinicalTrials.gov ID
- NCT04197011
- Acronym / sponsor ID
- IRAS237030
- Conditions
- Prostheses and Implants
- Keywords
- Prosthetics, Microprocessor, Hydraulic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Nottingham Trent UniversityUniversity, hospital or other
- Study start
- 6 Feb 2019 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 12 Dec 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.
Lower limb amputation is an emerging global health concern. Currently, there are over 1.6 million amputees in the U.S. and around 6000 new amputations are recorded per annum in the UK. These numbers are expected to double by 2050 due to the increasing aging population and the adverse health issues such as diabetes, representing a significant, growing problem in western society. A lower limb amputation results in the loss of the biological joint structures such as the ankle and knee, along with the associated musculature. In order to overcome these physical losses, many lower limb amputees are provided with a prosthetic limb that enable them to participate in activities of daily living. The design and function of these prosthetic limbs varies widely, with some being very basic, non-articulating, semi-rigid structures while other more advanced components are computer controlled or incorporate robotic function. Lower limb amputees have been shown to fall more often when compared to age matched individuals without lower limb amputation. This has been reported to be partly a result of a less stable walking pattern. Given that the prosthetic limb provided and it's functional capability is a large component of how well a lower limb amputee is able to walk, it is important to understand what the effects of and potential benefits are from using more advanced prosthetic devices, such as micro-processor controlled knee joints and articulating ankle joints.
Therefore, the aim of the current study is to investigate the effects of combining more advanced prosthetic ankle-foot and knee components on the biomechanics of activities of daily living in individuals with above knee amputation.
Detailed description
Study Background Lower limb amputation is an emerging global health concern. Currently, there are over 1.6 million amputees in the U.S. and around 6000 new amputations are recorded per annum in the UK. These numbers are expected to double by 2050 due to the increasing aging population and the adverse health issues such as diabetes, representing a significant, growing problem in western society. A lower limb amputation results in the loss of the biological joint structures such as the ankle and knee, along with the associated musculature. In order to overcome these physical losses, many lower limb amputees are provided with a prosthetic limb that enable them to participate in activities of daily living. The design and function of these prosthetic limbs varies widely, with some being very basic non-articulating semi-rigid structures while other more advanced components are computer controlled and function robotically. Advanced ankle components have been shown to provide lower limb amputees with a number of benefits including increased walking speed, improved symmetry between legs and increased forward progression. In addition, micro-processor controlled knee components, recently made available through the NHS via NHS England Clinical commissioning, have shown a number of benefits. These benefits are stated as being '…enhanced stability and stumble recovery, which improves fall management and reduces the incidence of falls. This supports the increases in self-reported improved individual mobility and independence. MPKs also improve controlled sitting and standing, walking gait symmetry, stair decent, controlled step over step descent down a slope, reduced energy expenditure, and given different modes for different activities an ability to manage obstacles more easily'. Given that the prosthetic limb provided and their functional capability is a large component of how well a lower limb amputee is able to walk, it is important to understand what the effects of and potential benefits are from using more advanced prosthetic devices, such as micro-processor controlled knee joints. Also, as these components are used in conjunction with ankle-foot devices, it is important to know what the optimal combination may be to gain the most benefits from both prosthetic components.
Study Aim The aim of the current study is to investigate the effects of combining more advanced prosthetic ankle-foot and knee components on the biomechanics of activities of daily living in individuals with above knee amputation.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prosthesis users | – | Device: prosthetic deviceIndividuals with unilateral transfemoral amputation. |
| Control | – | –Individuals without unilateral transfemoral amputation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study aims to recruit two groups of participants, one group of individuals with unilateral transfemoral amputation (TFA) and a group of otherwise healthy control participants (CRTL). Both groups are required to satisfy inclusion and exclusion criteria and provide written informed consent in order to participate.
Key inclusion criteria (9 listed)
- Transfemoral amputation: Individuals who have had unilateral transfemoral amputation.
- Demographics: Adult, community-dwelling individuals above the age of 18 in order to provide written informed consent for themselves.
- Mental Capacity: Ability to comprehend and understand communication and instruction in English in order to consent and safely participate in study as assessed verbally.
- Mobility level: Prospective participants must be able to negotiate obstacles such as ramps and stairs thus displaying a level of mobility commensurate with a medicare K3 functional classification level.
- Endurance Capacity: Able to walk continuously for periods of up to two minutes at a time in order to complete the clinical walking tests.
Key exclusion criteria (9 listed)
- Pain: Experience undue musculo-skeletal pain during walking that causes individual to stop and not be able to continue when walking at a self-selected speed.
- Disease/Illness: Unable and/or unsafe to carry out tasks due to disease/illness such as rheumatoid arthritis.
- Injury: Current neuromuscular, musculoskeletal injury.
- Falls: Falls regularly (>1 a month) as determined using the PROFANE fall definition. Excludes recreational, sporting or occupational falls outside of this definition.
- Residuum health: Presence of significant blisters, wounds and rash which prevent prosthesis, sock and liner to be worn comfortably.
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 |
|---|---|---|
| prosthetic deviceIndividuals with TFA will use a combination of prosthetic devices. | Device | Prosthesis users |
Primary outcome
Obstacle Course Completion Time (seconds)
Time frame: All experimental conditions - up to six weeks
The total time taken to complete one lap of a custom walking course in seconds.
10 secondary outcomes
Two-minute walk (2MWT) test (metres)
Time frame: All experimental conditions - up to six weeks
The timed up and Go (TUG) test
Time frame: All experimental conditions - up to six weeks
The L-test
Time frame: All experimental conditions - up to six weeks
Berg Balance Scale
Time frame: All experimental conditions - up to six weeks
EQ-5D-5L
Time frame: All experimental conditions - up to six weeks. Only applicable for participants who are currently trialling an MPK.
Activities Balance Confidence Scale-UK (ABC-UK)
Time frame: All experimental conditions - up to six weeks. Only applicable for participants who are currently trialling an MPK.
Locomotor Capabilities Index (LCI)
Time frame: All experimental conditions - up to six weeks. Only applicable for participants who are currently trialling an MPK.
The Houghton Scale
Time frame: All experimental conditions - up to six weeks. Only applicable for participants who are currently trialling an MPK.
Custom Falls Report
Time frame: All experimental conditions - up to six weeks. Only applicable for participants who are currently trialling an MPK.
The Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form
Time frame: All experimental conditions - up to six weeks. Only applicable for participants who are currently trialling an MPK.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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.
Cleveland Barnett, Ph.D principal investigator
Nottingham Trent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostheses and Implants, run by Nottingham Trent University at 1 site in United Kingdom.
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 9 inclusion and 9 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 12 Oct 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 Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Obstacle Course Completion Time (seconds) (time frame: All experimental conditions - up to six weeks). 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 12 Oct 2022.