NCT01551420

Home Study of an Advanced Upper Limb Prosthesis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Traumatic Amputation of Arm

Interventions

Type	Name	Description
DEVICE	Advanced upper limb prosthetic device IMU controlled	Advanced upper limb prosthetic IMU controlled
DEVICE	Advanced upper limb prosthetic EMG-PR controlled	Advanced upper limb prosthetic EMG-PR controlled

Timeline

• Start date: 2012-04-01
• Primary completion: 2017-12-19
• Completion: 2018-12-31
• First posted: 2012-03-12
• Last updated: 2019-04-30
• Results posted: 2019-04-30

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study