Abstract
Objective: To compare comfort and functional performance of the Northwestern University Flexible Subischial Vacuum (NU-FlexSIV) Socket with the ischial containment (IC) socket in persons with unilateral transfemoral amputation. Design: Randomized crossover trial with two 7-week periods. Setting: Private prosthetic clinics and university research laboratory. Participants: A total of 30 enrolled (N=30); 25 participants completed the study with full (n=18) or partial data (n=7). Interventions: Two custom-fabricated sockets (IC and NU-FlexSIV), worn full-time for 7 weeks, with testing at 1, 4, and 7 weeks after socket delivery. Main Outcome Measures: The primary outcome was change in Socket Comfort Score (SCS) at 7 weeks. Secondary outcomes at 7 weeks included the Orthotic and Prosthetic Users’ Survey (OPUS) to assess lower extremity functional status, health-related quality of life, and satisfaction with device, as well as the 5-Times Rapid Sit-to-Stand Test, Four Square Step Test, and T-Test of Agility to assess functional performance. Results: At 7 weeks, the mean SCS for IC (7.0±1.7) and NU-FlexSIV (8.4±1.1) Sockets were significantly different (P<.001; 95% confidence interval, 0.8-2.3). Results from a linear mixed-effects model, accounting for data from all time points, indicated that the SCS was 1.7 (SE=0.45) points higher for the NU-FlexSIV Socket (P<.001). For the secondary outcomes, only OPUS satisfaction with device was significantly better in the NU-FlexSIV Socket after accounting for all data points. Conclusions: The results suggest that after 7 weeks’ accommodation, the NU-FlexSIV Socket was more comfortable and led to greater satisfaction with device than the IC socket in persons with unilateral transfemoral amputation and K3/K4 mobility. Other patient-reported outcomes and function were no different between sockets.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 2063-2073.e2 |
| Journal | Archives of physical medicine and rehabilitation |
| Volume | 102 |
| Issue number | 11 |
| DOIs | |
| State | Published - Nov 2021 |
Funding
Supported by the Assistant Secretary of Defense for Health Affairs , through the Peer Reviewed Orthopaedic Research Program (award no. W81XWH-15-1-0708 ). Opinions, interpretations, conclusions, and recommendations are those of the author and are not necessarily endorsed by the Department of Defense. Supported in part by the National Institutes of Health's National Center for Advancing Translational Sciences (grant no. UL1TR001422 ). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The sponsors had no role in the study design, collection, analysis, and interpretation of data, writing of the report, or the decision to submit the article for publication. Supported by the Assistant Secretary of Defense for Health Affairs, through the Peer Reviewed Orthopaedic Research Program (award no. W81XWH-15-1-0708). Opinions, interpretations, conclusions, and recommendations are those of the author and are not necessarily endorsed by the Department of Defense. Supported in part by the National Institutes of Health's National Center for Advancing Translational Sciences (grant no. UL1TR001422). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The sponsors had no role in the study design, collection, analysis, and interpretation of data, writing of the report, or the decision to submit the article for publication.
Keywords
- Artificial
- Artificial limbs
- Leg
- Leg prosthesis
- Rehabilitation
- Rehabilitation outcome
ASJC Scopus subject areas
- Rehabilitation
- Physical Therapy, Sports Therapy and Rehabilitation