Home Study of an Advanced Upper Limb Prosthesis

Completed · Not applicable

Conditions studied: Traumatic Amputation of Arm

In brief

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.

Key facts

Study ID

NCT01551420

Run by

VA Office of Research and Development

People needed

52

Starts

2012-04-01

Expected to finish

2018-12-31

Last updated by the study team

2019-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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