Clinical trial NCT02678247: Functional Performance Evaluation of NU-FlexSIV Socket
Official title: Functional Performance Evaluation of the Northwestern University Flexible Sub-Ischial Vacuum (NU-FlexSIV) Socket for Persons With Transfemoral Amputation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation
Artificial Limbs
Keywords: prosthesis
prosthetic socket
transfemoral amputation
socket comfort
gait biomechanics
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Jesse Brown VA Medical Center
name: Scheck and Siress
First posted: 2016-02-09
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The overall objective of this study is to provide a more comfortable and functional prosthetic socket for persons with transfemoral amputation that will ultimately improve their quality of life.

Detailed description: The proposed clinical trial will be an assessor-blinded prospective randomized cross-over trial wherein participants with unilateral transfemoral amputation will be randomized to using one of two socket conditions (i.e., sub-ischial or ischial containment) before crossing over to the other socket condition. Random allocation (computer-generated) utilizing blocks of random size will be used to assign the initial treatment condition. The trial will be balanced such that all subjects will receive all treatments (i.e., both socket conditions) and that all subjects will participate for the same number of periods (i.e., two). While a washout period is not strictly necessary, it is effectively included as subjects will need to transition back to their usual, pre-study socket/prosthesis while the second test socket is fabricated.

Allocation of intervention will be concealed from the investigators until after a subject is enrolled. The starting socket design will be enclosed in sequentially numbered, opaque, sealed envelopes. Envelopes will be opened sequentially and only after the participant's name and other details are written on the appropriate envelope.

Blinding of prosthetic interventions is challenging given that they are devices that must be custom-fabricated and donned each day by the subject. Hence, for this study only the assessor will be blinded. The blinded assessor will be responsible for administration of the clinical performance and patient-reported measures as well as processing of motion analysis data.

Eligibility criteria: Inclusion Criteria:

* unilateral transfemoral amputation
* have used a prosthesis for two or more years
* have a residual limb that is stable in volume and free from wounds
* be physically fit enough to participate in the performance tests (Medicare Functional Classification Level K3 or K4)
* have no previous experience of the sub-ischial socket
* able to complete all visits for the duration of the protocol

Exclusion Criteria:

* have a residual limb femur of less than 5-inches
* co-morbidities that affect function, including neurologic abnormalities (e.g. neuropathic pain that would interfere with the study)
* do not speak and read English

Primary outcomes:
measure: Socket Comfort Score (SCS) Between IC Socket and NU-FlexSIV Sockets at 7 Weeks.
timeFrame: 7 weeks
Secondary outcomes:
measure: Walking Speed Between the IC Socket and NU-FlexSIV Socket at 7 Weeks.
timeFrame: 7 weeks
measure: Step Length Between the IC Socket and NU-FlexSIV Socket at 7 Weeks.
timeFrame: 7 weeks
measure: Hip Extension Between the IC Socket and NU-FlexSIV Socket at 7 Weeks.
timeFrame: 7 weeks
measure: Hip Range of Motion Between the IC Socket and NU-FlexSIV Socket 7 Weeks.
timeFrame: 7 weeks
measure: Trunk Motion Between the IC Socket and NU-FlexSIV Socket at 7 Weeks.
timeFrame: 7 weeks
measure: Orthotics and Prosthetics Users' Survey (OPUS) Lower-Extremity Functional Status Measure Between the IC Socket and NU-FlexSIV Socket at 7 Weeks
timeFrame: 7 weeks
measure: Orthotics andProsthetics Users' Survey (OPUS) Health Related Quality of Life Index Between the IC Socket and NU-FlexSIV Socket at 7 Weeks.
timeFrame: 7 weeks
measure: Orthotics and Prosthetics Users' Survey (OPUS) Satisfaction With Device Between the IC Socket and NU-FlexSIV Socket at 7 Weeks.
timeFrame: 7 weeks
measure: 5-Times Rapid Sit-to-Stand Test (RSTS) Between the IC Socket and NU-FlexSIV Socket at 7 Weeks.
timeFrame: 7 weeks
measure: Four-Square-Step Test (FSST) Between the IC Socket and NU-FlexSIV Socket at 7 Weeks.
timeFrame: 7 weeks
measure: T-Test of Agility (T-Test) Between the IC Socket and NU-FlexSIV Socket at 7 Weeks.
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Jesse Brown VA Medical Center Motion Analysis Research Laboratory
state: Illinois
city: Chicago
country: United States
facility: Northwestern University Prosthetics-Orthotics Center
state: Illinois
city: Oakbrook Terrace
country: United States
facility: Scheck and Siress Prosthetics Orthotics
state: Illinois
Study officials:
affiliation: Northwestern University
name: Stefania Fatone, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fatone S, Stine R, Caldwell R, Angelico J, Gard SA, Oros M, Major MJ. Comparison of Ischial Containment and Subischial Sockets Effect on Gait Biomechanics in People With Transfemoral Amputation: A Randomized Crossover Trial. Arch Phys Med Rehabil. 2022 Aug;103(8):1515-1523. doi: 10.1016/j.apmr.2022.02.013. Epub 2022 Mar 13.
citation: Fatone S, Caldwell R, Angelico J, Stine R, Kim KY, Gard S, Oros M. 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. Arch Phys Med Rehabil. 2021 Nov;102(11):2063-2073.e2. doi: 10.1016/j.apmr.2021.05.016. Epub 2021 Jun 29.