Advanced Prosthetic Devices for Lower Limb Amputees

NCT04197011 | Completed

• 1 other identifier: IRAS237030
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostheses and Implants

Keywords

Prosthetics; Microprocessor; Hydraulic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Two-minute walk (2MWT) test (metres)

  All experimental conditions - up to six weeks

• The timed up and Go (TUG) test

  All experimental conditions - up to six weeks

• The L-test

  All experimental conditions - up to six weeks

• Berg Balance Scale

  All experimental conditions - up to six weeks

• EQ-5D-5L

  All experimental conditions - up to six weeks. Only applicable for participants who are currently trialling an MPK.

Study Arms (2)

Prosthesis users

Individuals with unilateral transfemoral amputation.

Device: prosthetic device

Control

Individuals without unilateral transfemoral amputation.

Interventions

prosthetic device DEVICE

Individuals with TFA will use a combination of prosthetic devices.

Prosthesis users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Nottingham Trent University: lead

Study Sites (1)

The Biomechanics Lab, CELS Building, Nottingham Trent University

Nottingham, Notts, NG11 8NS, United Kingdom

Location

MeSH Terms

Interventions

Artificial Limbs

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies; Artificial Organs; Surgical Equipment; Orthopedic Equipment

Study Officials

• Cleveland Barnett, Ph.D

  Nottingham Trent University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 12, 2019
• Study Start: February 6, 2019
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-10

Locations

GB (1)