Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Change in Comfort between laminated and adjustable sockets using the Socket Fit Comfort Score |
The Socket Fit Comfort Score (SCS) is a single question in which subjects are asks: "On a scale from 0-10, if 0 represents the most uncomfortable socket fit you can imagine and 10 represents the most comfortable socket fit, how would you score the comfort of the socket fit of your artificial limb at the moment?" |
Baseline and 3 weeks post-intervention |
|
| Primary |
Change in Comfort between laminated and adjustable prosthesis using the Socket Fit Comfort Score |
The Socket Fit Comfort Score (SCS) is a single question in which subjects are asks: "On a scale from 0-10, if 0 represents the most uncomfortable socket fit you can imagine and 10 represents the most comfortable socket fit, how would you score the comfort of the socket fit of your artificial limb at the moment?" |
baseline and 3 weeks post-intervention |
|
| Primary |
Change in Satisfaction and Quality of life between laminated and adjustable sockets using the Prosthetic Evaluation Questionnaire (PEQ) |
The PEQ consists of 82 questions that describe the function of a lower-limb prosthesis and assess prosthesis-related quality of life. The questionnaire is divided into ten functional scales, addressing four major domains: prosthetic function, mobility, psychosocial experience, and well-being. |
Baseline and 3 weeks post-intervention |
|
| Primary |
Change in Prosthetic Satisfaction between laminated and adjustable sockets using the Prosthetic Socket Preference Questionnaire |
This asks which device they prefer on a 100 mm visual analog scale from their prescribed laminated socket to the test socket. A score of 0 would be 100% preference for their prescribed socket while 100 mm represents 100% preference for the socket tested in that condition. |
Baseline and 3 weeks post-intervention |
|
| Primary |
Change in Confidence in different activities between laminated and adjustable sockets using the Activities Specific Balance Confidence Scale (ABC Scale) |
The ABC scale is a 16-item self-reported measure scored on a rating scale from 0 to 100, with higher scores indicate greater balance confidence. An average score is calculated by adding all item scores and dividing by the total number of items. The ABC scale has demonstrate high internal consistency, good test-retest validity, and good construct validity in people with lower limb amputation. |
Baseline and 3 weeks post-intervention |
|
| Primary |
Change in mobility as measured by the 10-meter walk test |
The 10-m walk test measures elapsed time over 10 m from a standing start (Datta et al. 1996). This measure uses customary walking speed as a measure of walking ability/capacity and has shown content and metric reliability and validity (Deathe et al. 2009). |
day 1 and 3 weeks post-intervention |
|
| Primary |
Change in mobility as measured by Timed Up and Go (TUG) |
The timed-up-and-go (TUG) assesses several aspects of mobility including getting out of a chair, walking 3 m, turning, and sitting down (Schoppen et al. 1999). The outcome is the time from buttocks off the chair to buttocks down. |
baseline and 3 weeks post-intervention |
|
| Primary |
Change in mobility as measured by Five Times Sit To Stand (FTSTS) |
FTSTS is a measure of functional mobility, lower limb strength, and dynamic balance. |
baseline and 3 weeks post-intervention |
|
| Primary |
Change in mobility as measured by the Prosthetic Limb Users Survey of Mobility (PLUMS-M) 12-item short form |
The full PLUS-M survey has 44 items and there are two short-forms (12 and 7 items each). Here we will use the 12-item short form as it has shown excellent agreement with the 44-item score and good construct validity (Hafner et al. 2017). Additionally, normative data for 1019 people with lower limb amputation is available at (http://www.plus-m.org) to aid in interpretation of the findings. |
Baseline and 3 weeks post-intervention |
|
| Primary |
Change in mobility as measured by the L-Test |
The L-test (Deathe and Miller 2005) is a modified version of the TUG which incorporates two transfers and four turns of which at least one would be to the opposite side (Fig 6). We will complete both tasks as the TUG has ceiling effects in fit individuals and the L-Test can be too difficult for some amputees |
Baseline and 3 weeks post-intervention |
|
| Primary |
Change in Prosthetic Wear Time between laminated and adjustable sockets |
Participants will be given sensors to monitor how many times participants don and doff the prosthesis during the day. This sensor will be attached to each socket after the 3rd week of accommodation. This sensor will be worn for 1 week. |
Baseline and 3 weeks post-intervention |
|
| Primary |
Change in physical activity levels at home between laminated and adjustable sockets |
Participants will wear accelerometers to measure physical activity and step count. Participants will wear these monitors for 1 week. |
Baseline and 3 weeks post-intervention |
|
