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Traumatic Amputation of Arm | Home Study of an Advanced Upper Limb Prosthesis

Traumatic Amputation of Arm research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Traumatic Amputation of Arm

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:Advanced upper limb prosthetic device IMU controlledAdvanced upper limb prosthetic IMU controlled

Device:Advanced upper limb prosthetic EMG-PR controlledAdvanced upper limb prosthetic EMG-PR controlled

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Advanced upper limb prosthetic device IMU controlledSubjects with upper limb amputation who are trained to use a DEKA Arm with IMU controls

Advanced upper limb prosthetic EMG-PR controlledSubjects with TR or TH upper limb amputation who are trained to use a DEKA Arm with EMG-PR Controls

Study Status

Active, not recruiting

Start Date: April 1, 2012

Completed Date: December 31, 2018

Phase:

Type: Observational

Design:

Primary Outcome: Change in Quality of Life (QOL) scale

Secondary Outcome: Upper Extremity Functional Scale (UEFS) from the Orthotics and Prosthetics Users Survey (OPUS) Use scale

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: VA Office of Research and Development

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01551420

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, 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. 2018 May 9:1-15. doi: 10.1080/17483107.2018.1467973. [Epub ahead of print]

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.

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