Home Study of an Advanced Upper Limb Prosthesis (NCT01551420) | Clinical Trial Compass
CompletedNot Applicable
Home Study of an Advanced Upper Limb Prosthesis
United States52 participantsStarted 2012-04-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 wou…
What they're measuring
1
Change in Quality of Life (QOL) Scale
Timeframe: baseline and after 9-12 weeks of home use (end of Part B)