Home Study of an Advanced Upper Limb Prosthesis

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.

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.