Advanced Prosthetic Devices for Lower Limb Amputees

Prostheses and Implants Clinical Trial

Official title:

Investigating the Effects of Micro-processor Controlled Knee Components on the Function and Performance of Individuals With Transfemoral Amputation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04197011
• Other study ID #: IRAS237030
• Status: Completed
• Start date: February 6, 2019
• Est. completion date: October 1, 2022

Study information

• Verified date: October 2022
• Source: Nottingham Trent University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Transfemoral amputation: Individuals who have had unilateral transfemoral amputation.

2. Demographics: Adult, community-dwelling individuals above the age of 18 in order to provide written informed consent for themselves.

3. Mental Capacity: Ability to comprehend and understand communication and instruction in English in order to consent and safely participate in study as assessed verbally.

4. 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.

5. Endurance Capacity: Able to walk continuously for periods of up to two minutes at a time in order to complete the clinical walking tests.

6. Vision: Good (corrected) vision to safely walk in well-lit areas.

7. Cardiovascular Health: No self-reported unresolved cardiovascular complaints to avoid any cardiovascular complications when performing activities of daily living.

8. 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.

Exclusion Criteria:

1. 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.

2. Disease/Illness: Unable and/or unsafe to carry out tasks due to disease/illness such as rheumatoid arthritis.

3. Injury: Current neuromuscular, musculoskeletal injury.

4. Falls: Falls regularly (>1 a month) as determined using the PROFANE fall definition. Excludes recreational, sporting or occupational falls outside of this definition.

5. Residuum health: Presence of significant blisters, wounds and rash which prevent prosthesis, sock and liner to be worn comfortably.

6. 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.

7. Unable to follow instruction or cognitive deficits: Risk of further injury whilst completing tasks incorrectly.

8. Not able to understand written and verbal English: All communication will be in English as the University does not provide translation services.

9. For the otherwise healthy control (CTRL) group, the same criteria apply, with the exception of those pertaining specifically to amputation status.

Related Conditions & MeSH terms

• Prostheses and Implants

Intervention

Device:
• prosthetic device
Individuals with TFA will use a combination of prosthetic devices.

Locations

Country	Name	City	State
United Kingdom	The Biomechanics Lab, CELS Building, Nottingham Trent University	Nottingham	Notts

Sponsors (1)

Lead Sponsor	Collaborator
Nottingham Trent University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Two-minute walk (2MWT) test (metres)	The total distance walked in two minutes along a 13m walkway.	All experimental conditions - up to six weeks
Secondary	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	All experimental conditions - up to six weeks
Secondary	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
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.