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Functional Performance Evaluation of NU-FlexSIV Socket

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ClinicalTrials.gov Identifier: NCT02678247
Recruitment Status : Recruiting
First Posted : February 9, 2016
Last Update Posted : March 29, 2018
Sponsor:
Collaborators:
United States Department of Defense
Jesse Brown VA Medical Center
Scheck and Siress Prosthetics Orthotics
Information provided by (Responsible Party):
Stefania Fatone, PhD, BPO(Hons), Northwestern University

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.

Condition or disease Intervention/treatment Phase
Amputation Artificial Limbs Device: Northwestern University Flexible Sub-Ischial Vacuum Socket Device: Ischial Containment Socket Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Functional Performance Evaluation of the Northwestern University Flexible Sub-Ischial Vacuum (NU-FlexSIV) Socket for Persons With Transfemoral Amputation
Study Start Date : April 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Arm Intervention/treatment
Active Comparator: NU-FlexSIV Socket
The Northwestern University Flexible Sub-Ischial Vacuum Socket is a novel socket design for transfemoral amputees.
Device: Northwestern University Flexible Sub-Ischial Vacuum Socket
NU-FlexSIV sockets have lower proximal trim lines, do not impinge on the pelvis, are highly flexible so as to allow better comfort during sitting and when muscles move within the socket during activity, and are held securely to the residual limb by suction from a vacuum pump and from compression exerted by the deliberately undersized liner and socket.
Other Name: NU-FlexSIV Socket

Device: Ischial Containment Socket
Ischial Containment (IC) sockets are more rigid and have a narrower medio-lateral dimension than anterior-posterior dimension. The socket encapsulates the ischium, ischial ramus and greater trochanter, limiting hip range of motion and comfort.
Other Name: IC Socket

Active Comparator: IC Socket
The Ischial Containment Socket is the standard of care socket design for transfemoral amputees.
Device: Northwestern University Flexible Sub-Ischial Vacuum Socket
NU-FlexSIV sockets have lower proximal trim lines, do not impinge on the pelvis, are highly flexible so as to allow better comfort during sitting and when muscles move within the socket during activity, and are held securely to the residual limb by suction from a vacuum pump and from compression exerted by the deliberately undersized liner and socket.
Other Name: NU-FlexSIV Socket

Device: Ischial Containment Socket
Ischial Containment (IC) sockets are more rigid and have a narrower medio-lateral dimension than anterior-posterior dimension. The socket encapsulates the ischium, ischial ramus and greater trochanter, limiting hip range of motion and comfort.
Other Name: IC Socket




Primary Outcome Measures :
  1. Difference in Socket Comfort Score (SCS) between IC socket and NU-FlexSIV socket. [ Time Frame: At 1, 3 and 6 weeks of everyday socket use for each socket. ]
    SCS is an ordinal scale where the subject responds to the question, "On a 0 to 10 scale, 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 of your artificial limb at the moment?" While 6 weeks of everyday socket use is the primary end point, we anticipate that subjects may dropout if one socket is less comfortable, hence we are also collecting SCS at interim time points (1 and 3 weeks).


Secondary Outcome Measures :
  1. Difference in walking speed between the IC socket and NU-FlexSIV socket. [ Time Frame: At 1, 3 and 6 weeks of everyday socket use for each socket. ]
    Marker based motion capture will be used to assess walking speed (m/s). Subjects will walk along a 12 meter, level walkway at their self-selected speed.

  2. Difference in step length between the IC socket and NU-FlexSIV socket. [ Time Frame: At 1, 3 and 6 weeks of everyday socket use for each socket. ]
    Marker based motion capture will be used to assess step length (cm). Subjects will walk along a 12 meter, level walkway at their self-selected speed.

  3. Difference in hip extension between the IC socket and NU-FlexSIV socket. [ Time Frame: At 1, 3 and 6 weeks of everyday socket use for each socket. ]
    Marker based motion capture will be used to assess hip extension (degrees). Subjects will walk along a 12 meter, level walkway at their self-selected speed.

  4. Difference in hip range of motion between the IC socket and NU-FlexSIV socket. [ Time Frame: At 1, 3 and 6 weeks of everyday socket use for each socket. ]
    Marker based motion capture will be used to assess hip range of motion (degrees). Subjects will walk along a 12 meter, level walkway at their self-selected speed.

  5. Difference in trunk motion between the IC socket and NU-FlexSIV socket. [ Time Frame: At 1, 3 and 6 weeks of everyday socket use for each socket. ]
    Marker based motion capture will be used to assess trunk motion (degrees). Subjects will walk along a 12 meter, level walkway at their self-selected speed.

  6. Difference in Orthotics Prosthetics Users' Survey (OPUS) Lower-Extremity Functional Status Measure between the IC socket and NU-FlexSIV socket. [ Time Frame: At 1, 3 and 6 weeks of everyday socket use for each socket. ]
    The OPUS Lower-Extremity Functional Status Measure is a self-report instrument that assesses functional status in persons who use orthoses and prostheses. The OPUS Lower-Extremity Functional Status Measure is comprised of 20 items rated on a 5-point rating scale. Response to items are summed to produce a total score for the measure.

  7. Difference in Orthotics Prosthetics Users' Survey (OPUS) Health Related Quality of Life Index between the IC socket and NU-FlexSIV socket. [ Time Frame: At 1, 3 and 6 weeks of everyday socket use for each socket. ]
    The OPUS Health Related Quality of Life Index is self-report instrument comprised of 23 items that are evaluated with a 5-point rating scale. Response to items are summed to produce a total score for the index.

  8. Difference in Orthotics Prosthetics Users' Survey (OPUS) Satisfaction with Device between the IC socket and NU-FlexSIV socket. [ Time Frame: At 1, 3 and 6 weeks of everyday socket use for each socket. ]
    The OPUS Satisfaction with Device module is a set of 11 items rated on a 5-point rating scale. Response to items are summed to produce a total score.

  9. Difference in 5-Time Rapid Sit-to-Stand Test (RSTS) between the IC socket and NU-FlexSIV socket. [ Time Frame: At 1, 3 and 6 weeks of everyday socket use for each socket. ]
    Subjects are asked to rise from a chair of standard height five times as fast as possible with their arms folded across their chests. Timing begins when the examiner says "Go" and stops when the subject's buttocks touch the chair on the fifth repetition. Participants will perform two RSTS trials, with a three minute rest period between trials.

  10. Difference in Four-Square-Step Test (FSST) between the IC socket and NU-FlexSIV socket. [ Time Frame: At 1, 3 and 6 weeks of everyday socket use for each socket. ]
    Four sticks are placed flat on the floor in a cross that denotes a square at each of the four angles. Instructions to the subjects are, "Try to complete the sequence as fast as possible without touching the sticks. Both feet must make contact with the floor in each square. If possible, face forward during the entire sequence." The stepping sequence is demonstrated to the subject and one practice trial is allowed to ensure that the subject knows the sequence. The score is recorded as the time taken to complete the stepping sequence. The stopwatch starts when the first foot contacts the floor in square 2 and finishes when the last foot comes back to touch the floor in square 1.

  11. Difference in T-Test of Agility (T-Test) between the IC socket and NU-FlexSIV socket. [ Time Frame: At 1, 3 and 6 weeks of everyday socket use for each socket. ]
    Four cones are set out so a "T" can be traced among them. The subject starts at cone A. On the command of the timer, the subject sprints to cone B and touches the base of the cone with their right hand. Then they shuffle sideways to cone C, and also touch its base, this time with their left hand. Then shuffling sideways to the right to cone D and touching the base with the right hand. The subject then shuffles back to cone B touching with the left hand, and runs backward to cone A. The stopwatch is stopped as they pass cone A. The trial does not count if the subject crosses one foot in front of the other while shuffling sideways, fails to touch the base of the cones, or fails to face forward throughout the test. The best time of three successful trials is used.


Other Outcome Measures:
  1. Step Activity [ Time Frame: Between week 1 and week 3; and between week 3 and week 6. ]
    Step activity monitors attached to the test prostheses will allow monitoring of every day socket use. This will provide information regarding compliance with use of each prosthesis. As a secondary consideration, it will allow us to check whether there is a relationship between comfort and step activity.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678247


Contacts
Contact: Stefania Fatone, PhD 312-503-5717 s-fatone@northwestern.edu
Contact: Steven A. Gard, PhD 312-503-5718 sgard@northwestern.edu

Locations
United States, Illinois
Jesse Brown VA Medical Center Motion Analysis Research Laboratory Recruiting
Chicago, Illinois, United States, 60611
Contact: Steven A. Gard, PhD    312-503-5718    sgard@northwestern.edu   
Northwestern University Prosthetics-Orthotics Center Recruiting
Chicago, Illinois, United States, 60611
Contact: Stefania Fatone, PhD    312-503-5717    s-fatone@northwestern.edu   
Scheck and Siress Prosthetics Orthotics Recruiting
Oakbrook Terrace, Illinois, United States, 60181
Contact: Michael Oros, CPO    630-424-0392    michael.oros@scheckandsiress.com   
Sponsors and Collaborators
Northwestern University
United States Department of Defense
Jesse Brown VA Medical Center
Scheck and Siress Prosthetics Orthotics
Investigators
Principal Investigator: Stefania Fatone, PhD Northwestern University

Responsible Party: Stefania Fatone, PhD, BPO(Hons), Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT02678247     History of Changes
Other Study ID Numbers: W81XWH-15-1-0708
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Upon request, the PI will share de-identified data and outcomes. If the requests are excessive, data will be made available via a link on the Northwestern University Prosthetics-Orthotics Center (NUPOC) website.

Keywords provided by Stefania Fatone, PhD, BPO(Hons), Northwestern University:
prosthesis
prosthetic socket
transfemoral amputation
socket comfort
gait biomechanics