Clinical trial NCT01551420: Home Study of an Advanced Upper Limb Prosthesis
Official title: Home Study of an Advanced Upper Limb Prosthesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Amputation of Arm
Keywords: Amputation
Prosthetic Design
Upper Extremity
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2012-03-12
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sequential testing in non-equivalent comparison groups
Primary purpose: TREATMENT

Brief summary: The overall study objective is to examine the feasibility, acceptance, and benefits of home use of an advanced upper limb prosthetic device as well as the logistical support requirements utilized during 3 months of home usage. All participating subjects will enroll in Part A of the study which will involve supervised training. Eligible subjects will be invited to participate in Part B, the home use portion of the study.

Detailed description: The specific objectives of this study are to:

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.

Eligibility criteria: Inclusion Criteria:

Inclusion Criteria (Parts A and B):

* All subjects must be at least 18 years old and have single or bilateral upper limb amputation.
* 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.

Inclusion Criteria Part B only:

* Completion of all Part A study activities.
* Meets all criteria for Preliminary Determination of Appropriateness for Unsupervised, Home Device Use.

Exclusion Criteria:

Exclusion Criteria (Parts A and B):

* Amputees with elbow disarticulation, wrist disarticulation and partial hand amputations will be excluded. \*beginning July 1, 2016 amputees with shoulder disarticulation or forequarter amputation will be excluded.
* 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.

Primary outcomes:
measure: Change in Quality of Life (QOL) Scale
timeFrame: baseline and after 9-12 weeks of home use (end of Part B)
Secondary outcomes:
measure: Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS) Use Scale
timeFrame: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)
measure: Trinity Amputations and Prosthetics Experience Scale (TAPES) Satisfaction Scale
timeFrame: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)
measure: Activities Measure for Upper Limb Amputees (AM-ULA)
timeFrame: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)
measure: Three Scales of the Veterans Version of the SF-36
timeFrame: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)
measure: Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests
timeFrame: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)
measure: University of New Brunswick Test of Prosthetic Function (UNB)
timeFrame: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)
measure: Timed Measure of Activity Performance (T-MAP)
timeFrame: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)
measure: Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS)
timeFrame: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)
measure: The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT)
timeFrame: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)
Other outcomes:
Locations:
city: Tampa
country: United States
facility: James A. Haley Veterans' Hospital, Tampa, FL
state: Florida
city: New York
country: United States
facility: Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
state: New York
city: Providence
country: United States
facility: Providence VA Medical Center, Providence, RI
state: Rhode Island
city: San Antonio
country: United States
facility: Center for the Intrepid/ Brooke Army Medical Center
state: Texas
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.