Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prosthesis users | Individuals with unilateral transfemoral amputation. |
| |
| Control | Individuals without unilateral transfemoral amputation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prosthetic device | Device | Individuals with TFA will use a combination of prosthetic devices. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Obstacle Course Completion Time (seconds) | The total time taken to complete one lap of a custom walking course in seconds. | All experimental conditions - up to six weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Two-minute walk (2MWT) test (metres) | The total distance walked in two minutes along a 13m walkway. | 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 |
Not provided
Inclusion Criteria:
For the otherwise healthy control (CTRL) group, the same criteria apply, with the exception of those pertaining specifically to amputation status.
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Cleveland Barnett, Ph.D | Nottingham Trent University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Biomechanics Lab, CELS Building, Nottingham Trent University | Nottingham | Notts | NG11 8NS | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001186 | Artificial Limbs |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | 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). | 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. | 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. | 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). | 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). | 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. | 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'. | All experimental conditions - up to six weeks. Only applicable for participants who are currently trialling an MPK. |
| D009983 |
| Orthopedic Equipment |