None listed
Conditions
Brief summary
The most important part of the artificial limb is the socket, which forms the interface between the amputee’s residual limb and prostheses. The design and fitting of the socket is a difficult task due to the uniqueness of each amputee’s residual limb. Every fitting requires much attention from the prosthetist. Although there exists some guidelines to design and fit sockets for different levels of amputation, a successful fitting is still highly dependent on the skill and experience of the prosthetist. The purpose of this study is to examine the comfort of a socket made by an new technique known as pressure casting (PCAST). The aim of this study is to examine the comfort and function of the PCAST socket. This will be done by measuring the walking pattern and level of mobility with the PCAS Tlimb and the pressure between the residual limb and the PCAST socket during walking. Walking patterns and pressures will be recorded by high-tech “state of the art” non-invasive measurement systems located at the Vietnamese Training Centre for Orthopaedic Technologists (VIETCOT) in Hanoi. A total of 50 people will participate in this study.
Interventions
Intervention Name: Pressure cast (PCAST) Prosthetic Socket
This study was conducted at the Vietnamese Training Centre for Orthopaedic Technologists (VIETCOT) clinic in Hanoi, Vietnam. VIETCOT staff with International Society for Prosthetics and Orthotics (ISPO) category II qualifications cast, fabricated and fitted the PCAST sockets. Briefly, the PCAST technique involved wrapping participants’ residual limb, wearing a cotton sock, in plaster wrap uniformly; followed by placement of the limb into
Intervention Name: Pressure cast (PCAST) Prosthetic Socket This study was conducted at the Vietnamese Training Centre for Orthopaedic Technologists (VIETCOT) clinic in Hanoi, Vietnam. VIETCOT staff with International Society for Prosthetics and Orthotics (ISPO) category II qualifications cast, fabricated and fitted the PCAST sockets. Briefly, the PCAST technique involved wrapping participants’ residual limb, wearing a cotton sock, in plaster wrap uniformly; followed by placement of the limb into the PCAST tank (made of polyvinyl chloride) filled with water, separated from the limb by a polyethelene diaphragm. The water pressure was increased until the participants could stand with 50% of their weight supported by the pressurised water. Once the plaster wrap hardened, the tank was depressurised and the plaster removed. No rectifications to the positive socket mould based on the plaster wrap were performed with the exception of the smoothing of obvious rough edges. The hard socket was manufactured using standard International Committee of the Red Cross (ICRC) techniques using ICRC polypropylene technology. The casting and initial fitting of the prosthetic socket took approximately 2 hours. The socket was manufactured once, after which the participants completed a usage period of approximately 5 months. During this time they were under no obligation to use the prosthesis and could replace it with their original prosthesis at any time. There were no strategies to monitor adherence to the study or use of the socket until the participants self-reported use when they returned after the extensive usage period
Sponsors
The University of Melbourne
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligibility for the study dictated that participants were 18 years or older, active wearers and long-term users of their prosthesis.
Exclusion criteria
Significant co-morbidities which affect their ability to provide quality feedback comparing their previous prostheses to that of the PCAST or complete the physical function tests. In addition, they will require minimal physiotherapy or gait training prior to limb use or require walking aids additional to a prosthetic limb (e.g. canes or walkers).
Outcome results
None listed