transtibial amputation. Acquired absence of unspecified leg below knee
Conditions
Interventions
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 th
Sponsors
Hamedan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: diseased to background diseases or a canser a history of knee ligament injury or laxity pain in lower limbs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNahid Tafti
Hamedan University of Medical Sciences
Outcome results
None listed