ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12617001338358

Ethics application status

Approved

Date submitted

15/09/2017

Date registered

21/09/2017

Date last updated

26/10/2021

Date data sharing statement initially provided

26/10/2021

Date results provided

26/10/2021

Type of registration

Retrospectively registered

Titles & IDs

Public title

Clinical outcomes of the pressure cast technique to create low-cost prosthetic sockets for Vietnamese participants with below knee amputations

Scientific title

Clinical evaluation of a hydrocast technique for transtibial socket fit in Vietnamese participants with below knee amputations

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Transtibial amputation

Condition category

Condition code

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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

Intervention code [1]

Treatment: Devices

Comparator / control treatment

The clinical outcomes of the participants were initially assessed using their current or original limb. This data was used to compare the relative outcomes of the intervention socket (the PCAST socket).

Control group

Active

Outcomes

Primary outcome [1]

Six-minute-walk-test (distance a participant is able to walk in a 6 minute window)

Timepoint [1]