Study Results
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View full resultsBasic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2012-04-01
2018-12-31
Brief Summary
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Detailed Description
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1. identify and describe upper limb amputees who would be appropriate candidates for home use of this advanced prosthesis as well as those who would not be appropriate.
2. Compare the extent of use of the existing prosthesis to that of the DEKA Arm.and quantify the impact of home use of the DEKA Arm on device satisfaction, performance of functional activities and the user's quality of life.
3. Compare the outcomes of users of pattern recognition to the outcomes of users without
4. quantify the amount and type of technical support and repairs needed during the study, and estimate the number of home study days lost due to service/repair.
All participating subjects will enroll in Part A of the study, which will involve supervised, in-laboratory training, as well as supervised community based outings. Based upon the findings from Part A, study staff will classify participants as appropriate or not appropriate for participation in Part B (the home usage portion of the study). Final determination of appropriateness for home use will be made after a home visit. The home use portion of the study will last for 13 weeks and involve regularly scheduled study visits.
Measures of existing prosthetic activity will be compared with those of home use of the advanced upper limb prosthetic device to determine the extent of adoption. Changes in device satisfaction, performance of functional activities, and quality of life will be evaluated throughout the study. Data on technical support usage will also be gathered.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Advanced upper limb prosthetic device IMU controlled
Subjects with upper limb amputation who are trained to use a DEKA Arm with IMU controls
Advanced upper limb prosthetic device IMU controlled
Advanced upper limb prosthetic IMU controlled
Advanced upper limb prosthetic EMG-PR controlled
Subjects with TR or TH upper limb amputation who are trained to use a DEKA Arm with EMG-PR Controls
Advanced upper limb prosthetic EMG-PR controlled
Advanced upper limb prosthetic EMG-PR controlled
Interventions
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Advanced upper limb prosthetic device IMU controlled
Advanced upper limb prosthetic IMU controlled
Advanced upper limb prosthetic EMG-PR controlled
Advanced upper limb prosthetic EMG-PR controlled
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects must be able to understand the requirements of the study and sign an Informed Consent Form and HIPAA Authorization Form.
* Subjects will include those who are current users of any type of prosthetic device (body powered, electric or hybrid), non-users of devices who have been previously fit with a device, but have chosen not to wear it, as well as new users of devices.
* To participate in the study all subjects must have active control over one or both ankles, OR have an appropriate number of myoelectric and/or other control sites (as determined by the Principal Investigator in conjunction with the research team) to allow adequate prosthetic controls configuration.
* Completion of all Part A study activities.
* Meets all criteria for Preliminary Determination of Appropriateness for Unsupervised, Home Device Use.
Exclusion Criteria
* Amputees will be excluded if the length of their residual limb would prohibit socket fitting, as determined by the study prosthetist.
* Persons with significant uncorrectable visual deficits that would impair the ability to see the prosthesis and those who have major communication or neurocognitive deficits will be excluded.
* Persons with skin conditions such as burns or poor skin coverage as well as those with severe contractures that prevented prior prosthetic wear will be excluded.
* Persons with electrically controlled medical devices including pacemakers, and implanted defibrillators will be excluded.
* Persons with neuropathy, uncontrolled diabetes, who are receiving dialysis, have insensate feet, severe phantom pain or a history of skin ulcers or any other significant comorbidity which would interfere with the study will be excluded.
* Those with severe circulatory problems including peripheral vascular disease and pitting edema will be excluded.
* Persons with cognitive deficits or mental health problems that would limit their ability to participate fully in the study protocol will be excluded.
* Women who are pregnant or who plan to become pregnant in the near future will also be excluded.
* The investigators will exclude those amputees who work for prosthetic companies that may be considered competitors for the prosthetic arm technology in the future.
* Persons taking medication which poses a risk for operation of heavy equipment will be excluded.
18 Years
ALL
No
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Locations
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James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, United States
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
New York, New York, United States
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, United States
Center for the Intrepid/ Brooke Army Medical Center
San Antonio, Texas, United States
Countries
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References
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Resnik L, Borgia M, Acluche F. Brief activity performance measure for upper limb amputees: BAM-ULA. Prosthet Orthot Int. 2018 Feb;42(1):75-83. doi: 10.1177/0309364616684196. Epub 2017 Jan 16.
Resnik L, Borgia M, Acluche F. Timed activity performance in persons with upper limb amputation: A preliminary study. J Hand Ther. 2017 Oct-Dec;30(4):468-476. doi: 10.1016/j.jht.2017.03.008. Epub 2017 May 6.
Resnik LJ, Borgia ML, Acluche F. Perceptions of satisfaction, usability and desirability of the DEKA Arm before and after a trial of home use. PLoS One. 2017 Jun 2;12(6):e0178640. doi: 10.1371/journal.pone.0178640. eCollection 2017.
Resnik L, Fantini C, Latlief G, Phillips S, Sasson N, Sepulveda E. Use of the DEKA Arm for amputees with brachial plexus injury: A case series. PLoS One. 2017 Jun 19;12(6):e0178642. doi: 10.1371/journal.pone.0178642. eCollection 2017.
Resnik L, Acluche F, Borgia M. The DEKA hand: A multifunction prosthetic terminal device-patterns of grip usage at home. Prosthet Orthot Int. 2018 Aug;42(4):446-454. doi: 10.1177/0309364617728117. Epub 2017 Sep 15.
Resnik L, Acluche F, Lieberman Klinger S, Borgia M. Does the DEKA Arm substitute for or supplement conventional prostheses. Prosthet Orthot Int. 2018 Oct;42(5):534-543. doi: 10.1177/0309364617729924. Epub 2017 Sep 14.
Resnik L, Klinger S. Attrition and retention in upper limb prosthetics research: experience of the VA home study of the DEKA arm. Disabil Rehabil Assist Technol. 2017 Nov;12(8):816-821. doi: 10.1080/17483107.2016.1269212. Epub 2017 Jan 18.
Resnik, L. Cancio, J. Fantini, C. Ikeda, A. Sasson, N. Pattern Recognition Control of the DEKA Arm in Two Transhumeral Amputees with Target Muscle Reinnervation, Conference Proceedings, Myoelectric Control Conference (MEC), 2017
Resnik L, Cancio J, Klinger S, Latlief G, Sasson N, Smurr-Walters L. Predictors of retention and attrition in a study of an advanced upper limb prosthesis: implications for adoption of the DEKA Arm. Disabil Rehabil Assist Technol. 2018 Feb;13(2):206-210. doi: 10.1080/17483107.2017.1304585. Epub 2017 Apr 4.
Resnik LJ, Borgia ML, Acluche F, Cancio JM, Latlief G, Sasson N. How do the outcomes of the DEKA Arm compare to conventional prostheses? PLoS One. 2018 Jan 17;13(1):e0191326. doi: 10.1371/journal.pone.0191326. eCollection 2018.
Resnik L, Klinger S, Gill A, Ekerholm Biester S. Feminine identity and functional benefits are key factors in women's decision making about upper limb prostheses: a case series. Disabil Rehabil Assist Technol. 2019 Feb;14(2):194-208. doi: 10.1080/17483107.2018.1467973. Epub 2018 May 9.
Resnik L, Acluche F, Borgia M, Cancio J, Latlief G, Sasson N. Function, quality of life, and community integration of DEKA Arm users after discharge from prosthetic training: Impact of home use experience. Prosthet Orthot Int. 2018 Dec;42(6):571-582. doi: 10.1177/0309364618774054. Epub 2018 May 19.
Resnik LJ, Acluche F, Lieberman Klinger S. User experience of controlling the DEKA Arm with EMG pattern recognition. PLoS One. 2018 Sep 21;13(9):e0203987. doi: 10.1371/journal.pone.0203987. eCollection 2018.
Resnik LJ, Acluche F, Borgia M, Cancio J, Latlief G, Phillips S, Sasson N. EMG pattern recognition compared to foot control of the DEKA Arm. PLoS One. 2018 Oct 18;13(10):e0204854. doi: 10.1371/journal.pone.0204854. eCollection 2018.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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A9226-R
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
A0771-R
Identifier Type: -
Identifier Source: org_study_id
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