Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT01551420
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01551420
Study Brief:
Protocol Section:
NCT01551420