]>
IRCT20230528058315N5 IRCT 2026-04-28 Hamedan University of Medical Sciences Feasibility of using a localized version of a variable-volume socket in a below-knee amputee Feasibility of a six-week trial using a localized version of a variable-volume socket in a below-knee amputee regarding satisfaction, function, piston movements of the socket, and residual limb volume 2026-05-22 anticipated 1 Complete https://irct.ir/trial/89615 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Health service research. 1 transtibial amputation. Intervention group: Participant will be assessed at three time points during the use of the volume-adjustable socket: baseline, after 7 days, and after 49 days. Satisfaction will be evaluated using the Socket Comfort Score (SCS) and a prosthetic evaluation questionnaire. The vertical displacement of the socket relative to anatomical landmarks will be assessed through photography. Ambulatory capacity will be measured using the Timed Up and Go (TUG) test, and residual limb volume will be quantified via optical scanning. All evaluations will be conducted at the Mobasher Rehabilitation Center in Hamadan. This study does not include a control group.. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Nahid Tafti
Shahid Fahmideh
Hamadan Iran (Islamic Republic of) 6517838840 +98 81 3838 1571 Na.Tafti@yahoo.com Hamedan University of Medical Sciences scientific Nahid Tafti
Shahid Fahmideh
Hamadan Iran (Islamic Republic of) 6517838840 +98 81 3838 1571 Na.Tafti@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) unilateral transtibial amputation a residual limb length of at least 15 CM An activity level of K2 or Higher At least 8 months using the definitive socket use of total contact socket A BMI less than 28 Normal range of motion in joints of lower limbs lack of sensation neuropathy in the skin of residual limb according to evaluation by semmes wein stain monofilament of 5.7 18 years 85 years Both diseased to background diseases or a canser a history of knee ligament injury or laxity pain in lower limbs Z89.519 Acquired absence of unspecified leg below knee Rehabilitation Intervention group: Participant will be assessed at three time points during the use of the volume-adjustable socket: baseline, after 7 days, and after 49 days. Satisfaction will be evaluated using the Socket Comfort Score (SCS) and a prosthetic evaluation questionnaire. The vertical displacement of the socket relative to anatomical landmarks will be assessed through photography. Ambulatory capacity will be measured using the Timed Up and Go (TUG) test, and residual limb volume will be quantified via optical scanning. All evaluations will be conducted at the Mobasher Rehabilitation Center in Hamadan. This study does not include a control group. Socket comfort score. Timepoint: After 7 days of use at the baseline of the study and after 49 days of using the new socket. Method of measurement: Single-Question Socket Comfort Score Questionnaire. Total score of the Prosthesis Evaluation Questionnaire (PEQ). Timepoint: After 7 days of use at the baseline of the study and after 49 days of using the new socket. Method of measurement: The Persian version of the Prosthesis Evaluation Questionnaire. The amount of vertical displacement of the socket relative to anatomical landmarks under different standing conditions. Timepoint: Immediately after receiving the socket, after 7 days of using the socket, and after 49 days of using the socket. Method of measurement: Digital photography. Duration of Timed Up & Go test. Timepoint: Immediately after receiving the socket, after 7 days of using the socket, and after 49 days of using the socket. Method of measurement: Instructions for the Timed Up and Go (TUG) test: Upon hearing the signal "Go," the patient rises from a stable chair, walks a distance of three meters, turns around, returns to the chair, and sits down again. Residual limb volume from knee joint level to the end. Timepoint: Immediately after receiving the socket, after 7 days of using the socket, and after 49 days of using the socket. Method of measurement: After determining the knee joint level, an optical scan of the remaining limb will be performed using a Shining 3D Pro HD scanner, and the volume of the remaining limb will be calculated using Geomagic Design X software. Hamedan University of Medical Sciences Approved 2026-04-18 Ethics Committee of Hamadan University of Medical Sciences Shahid Fahmideh Hamadan Hamadan Iran (Islamic Republic of)