Comparison of Ischial Containment and Subischial Sockets on Comfort, Function, Quality of Life, and Satisfaction With Device in Persons With Unilateral Transfemoral Amputation: A Randomized Crossover Trial.
Artificial
Artificial limbs
Leg
Leg prosthesis
Rehabilitation
Rehabilitation outcome
Journal
Archives of physical medicine and rehabilitation
ISSN: 1532-821X
Titre abrégé: Arch Phys Med Rehabil
Pays: United States
ID NLM: 2985158R
Informations de publication
Date de publication:
11 2021
11 2021
Historique:
received:
18
11
2020
revised:
20
05
2021
accepted:
27
05
2021
pubmed:
3
7
2021
medline:
20
11
2021
entrez:
2
7
2021
Statut:
ppublish
Résumé
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. Randomized crossover trial with two 7-week periods. Private prosthetic clinics and university research laboratory. A total of 30 enrolled (N=30); 25 participants completed the study with full (n=18) or partial data (n=7). 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. 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. 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. 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.
Identifiants
pubmed: 34214499
pii: S0003-9993(21)00461-5
doi: 10.1016/j.apmr.2021.05.016
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT02678247']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, U.S. Gov't, Non-P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
2063-2073.e2Subventions
Organisme : NCATS NIH HHS
ID : UL1 TR001422
Pays : United States
Informations de copyright
Copyright © 2021 The American Congress of Rehabilitation Medicine. All rights reserved.