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

• Register: ANZCTR
• Last refreshed on: 1 November 2021
• Main ID: ACTRN12617001338358
• Date of registration: 21/09/2017
• Prospective Registration: No
• Primary sponsor: The University of Melbourne
• 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
• Date of first enrolment: 04/04/2011
• Target sample size: 50
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12617001338358.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Viet Nam

Contacts

• Name: Prof Peter Vee Sin Lee

• Name: Prof Peter Vee Sin Lee

Key inclusion & exclusion criteria

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).

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

Transtibial amputation;
Transtibial amputation

Intervention(s)

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

Primary Outcome(s)

Spatio-temporal gait data (the participant walks over an instrumented 4.57 m walkway (Gaitrite). Spatio-temporal gait data is a composite outcome and data collected included speed, cadence, step length, stride length, support base, swing time, stance time and single and double support times. [Before receiving PCAST limb (with current limb), 15 minutes after receiving PCAST limb, and approximately 5 months after receiving PCAST limb. ]

Timed-up-and-go Test (the time a participant takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down).[Before receiving PCAST limb (with current limb), 15 minutes after receiving PCAST limb, and approximately 5 months after receiving PCAST limb. ]

Six-minute-walk-test (distance a participant is able to walk in a 6 minute window)[Before receiving PCAST limb (with current limb), 15 minutes after receiving PCAST limb, and approximately 5 months after receiving PCAST limb. ]

Secondary Outcome(s)

Pressure profile at the interface of the socket and participants residual limb. The pressure data was collected using the F-socket residual limb/socket interface pressure measurement system (Tekscan Inc., USA). [Before receiving PCAST limb (with current limb), 15 minutes after receiving PCAST limb, and approximately 5 months after receiving PCAST limb. ]

Satisfaction with Prosthesis questionnaire (SATPRO). Validated survey (composite outcome) with 19 survey items to evaluate the most significant criteria used by the person when selecting a technical aid. Includes factors relating to comfort, ease of use and aesthetics.[Before receiving PCAST limb (with current limb), 15 minutes after receiving PCAST limb, and approximately 5 months after receiving PCAST limb. ]

Socket Comfort Score (SCS). Validated survey instrument to determine the users perceived socket comfort. Participants rated the comfort of their socket on a 0–10 scale where 0 represented the most uncomfortable and 10 the most comfortable sockets imaginable[Before receiving PCAST limb (with current limb), 15 minutes after receiving PCAST limb, and approximately 5 months after receiving PCAST limb. ]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Rotary Club of Richmond

CASS Foundation

Ethics review

Status: Approved
Approval date: 20/02/2011
Contact:

University of Labour and Social Affairs - Research Ethics

Status: Approved
Approval date: 07/09/2011
Contact:

The University of Melbourne Human Research Ethics Committee