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Below knee prosthesis socket

Comparison of the effect of modified prosthetic socket casting and fabricating method with total surface bearing socket on the satisfaction, socket fit and interface stress distribution in the unilateral below knee amputees.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20211019052810N1
Enrollment
8
Registered
2021-11-07
Start date
2021-11-06
Completion date
Unknown
Last updated
2021-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Unilateral below knee amputation (Right leg). Condition 2: Unilateral below knee amputation (Left leg). Complete traumatic amputation at level between knee and ankle, right lower leg, initial encounter Complete traumatic amputation at level between knee and ankle, left lower leg, initial encounter

Interventions

Intervention 1: Intervention group: Modified prosthetic socket. Due to the study is cross-over-design. All patients admitted to the study should wear each of the sockets in intervention groups 2 and 1

Sponsors

University of social welfare and rehabilitation sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Unilateral below the knee amputation minimum residual limb length should be 13 cm from the distal end of the patella to the end of the stamp Ability to use both PTB and TSB sockets and gel liner minimum history of 1 year prosthetesis usage ability to walk with or without an aid

Exclusion criteria

Exclusion criteria: Upper limb amputation or dysfunction Very long residual limb for using the shuttle lock Any progressive and non-progressive disability with psychological, neurological, rheumatological and orthopedic mobility problem except unilateral below knee amputation. Patients who are not able to complete the questionnaires due to cognitive problems Volume fluctuations caused by kidney disorders History of skin allergy to gel liner

Design outcomes

Primary

MeasureTime frame
Interface pressure. Timepoint: 1 month after socket fit. Method of measurement: Force Sensitive Resistors.;Satisfaction. Timepoint: 1 month after socket fit. Method of measurement: Persian version of comprehensive lower-limb amputee socket survey questionnaire.;Socket fit. Timepoint: 1 month after socket fit. Method of measurement: Standard meter elastic bar and Kinovea software.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammadali Mardani

University of social welfare and rehabilitation sciences

natelnoory@yahoo.com+98 21 2222 7124

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026