Evaluation of the Northwestern University Subischial Socket for Persons With Transfemoral Amputation and Lower Mobility Levels
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Transfemoral Amputation
- Sponsor
- University of Washington
- Enrollment
- 84
- Locations
- 3
- Primary Endpoint
- Change in Socket Comfort Score (SCS)
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief Summary
The objective of this trial is to assess use and benefits of the subischial socket for persons with transfemoral amputation and lower mobility levels. Specifically, the investigators will evaluate whether the subischial socket improves comfort, socket wear time, mobility, participation, quality of life and satisfaction with device than the standard-of-care ischial containment socket.
Detailed Description
Prosthetic sockets that are currently used by persons with above-the-knee amputation (AKA) fit intimately with the thigh and pelvis, limiting hip motion and causing discomfort. Socket comfort while standing and sitting is of great importance to persons with lower limb amputation. Yet discomfort while sitting has been reported in 44% of persons with AKA. In those with AKA who are more sedentary, clinical observation indicates that socket discomfort in sitting results in less prosthesis wear time and less mobility with the prosthesis. Based on these observations, the investigators propose that improving socket comfort in persons with AKA who have lower mobility will increase the time spent wearing the socket, which will in turn increase mobility, and in turn again improve satisfaction with the prosthesis and overall quality-of-life. A new prosthetic socket design, the sub-ischial socket, which eliminates contact with the pelvis, has been developed with the intent of improving comfort and hip motion in people with AKA. In particular, sitting comfort has been highlighted as an advantage of this new socket design by early users. Therefore, the objective of this project is to assess use and benefits of the sub-ischial socket for persons with AKA and lower mobility levels. The investigators will evaluate whether the sub-ischial socket is more comfortable, improves prosthesis wear time, mobility, participation in society, satisfaction with device, skin-related quality-of-life, and health-related quality of life compared to the current standard-of-care socket design in persons with AKA and lower mobility levels. If a participant is eligible and enrolled into this study, participation would last about 10 months and would involve up to 8 in-person visits (for individuals receiving a new sub-ischial socket). Individuals receiving a new sub-ischial socket will also be asked to wear a step counter and temperature sensor and complete 11 remote survey assessments spread over the 10-month period of the study. Data will also be collected from a reference group of participants with transfemoral amputation and lower mobility levels who will not receive a sub-ischial socket. These participants will be assessed while wearing their clinically-provided, standard-of-care ischial containment socket. These participants will complete 8 remote survey assessments over a 10-month period.
Investigators
Stefania Fatone
Professor, School of Medicine
University of Washington
Eligibility Criteria
Inclusion Criteria
- •Speak and read English;
- •Provision of signed and dated informed consent form;
- •Stated willingness to comply with all study procedures and availability for the duration of the study;
- •All sexes and genders age 18 years and older;
- •Have a unilateral transfemoral or knee disarticulation amputation and have used a prosthesis for 1 year or more;
- •Be classified by their prosthetist as being a Medicare Functional Classification Level of K2 (limited community ambulator);
- •Have never worn a sub-ischial socket;
- •Current IC socket and prosthesis must be well fitting and maintained; current socket must have pelvic weightbearing and/or containment;
- •Participant has no plans to change the knee or foot in the next 10 months;
- •Willingness to adhere to the monitoring and new socket regimen;
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in Socket Comfort Score (SCS)
Time Frame: Change from week 12 to week 24 compared between Intervention and Reference Groups.
Single item self-report measure to rate average socket comfort on an 11-point scale where 0 represents the most uncomfortable socket fit participant can imagine and 10 represents the most comfortable socket fit participant can imagine. Participants will rate their socket comfort in general, and while sitting, standing, and walking.
Secondary Outcomes
- Temperature sensor(Intervention group only: Baseline period weeks 0-12; Intervention period weeks 0-24.)
- Step counter(Intervention group only: Baseline period weeks 0-4; Intervention period weeks 0-4 and 20-24.)
- Roland-Morris Disability Questionnaire (RMDQ)(All participants: Baseline period weeks 0, 4, 8, 12; Intervention group: Intervention period weeks 0, 4, 8, 12, 16, 20, 24; Reference group: Monitoring period weeks 4, 12, 20, 24.)
- Prosthesis Limb Users Survey-Mobility (PLUS-M)(All participants: Baseline period weeks 0, 4, 8, 12; Intervention group: Intervention period weeks 4, 8, 12, 16, 20, 24; Reference group: Monitoring period weeks 4, 12, 20, 24.)
- Activities-specific Balance Confidence (ABC) Scale(All participants: Baseline period weeks 0, 4, 8, 12; Intervention group: Intervention period weeks 4, 8, 12, 16, 20, 24; Reference group: Monitoring period weeks 4, 12, 20, 24.)
- Prosthesis Evaluation Questionnaire (PEQ) Residual Limb Health(All participants: Baseline period weeks 0, 4, 8, 12; Intervention group: Intervention period weeks 0, 4, 8, 12, 16, 20, 24; Reference group: Monitoring period weeks 4, 12, 20, 24.)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles(All participants: Baseline period weeks 0, 12; Intervention/Monitoring period weeks 4, 12, 24.)
- Falls(All participants: Baseline period weeks 0, 4, 8, 12; Intervention group: Intervention period weeks 0, 4, 8, 12, 16, 20, 24; Reference group: Monitoring period weeks 4, 12, 20, 24.)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10(All participants: Baseline period weeks 0, 12; Intervention/Monitoring period weeks 4, 12, 24.)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Depression(All participants: Baseline period weeks 0, 12; Intervention/Monitoring period weeks 4, 12, 24.)
- Orthotic and Prosthetic Users' Survey Satisfaction with Device (OPUS-SwD)(All participants: Baseline period weeks 0, 12; Intervention/Monitoring period weeks 4, 12, 24.)
- Charlson Comorbidity Index (CCI)(All participants: Baseline period week 0; Intervention/Monitoring period weeks 4, 24.)