Home Study of an Advanced Upper Limb Prosthesis
|ClinicalTrials.gov Identifier: NCT01551420|
Recruitment Status : Active, not recruiting
First Posted : March 12, 2012
Last Update Posted : March 19, 2018
|Condition or disease||Intervention/treatment|
|Traumatic Amputation of Arm||Device: Advanced upper limb prosthetic device|
The specific objectives of this study are to:
- 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.
- 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.
- Compare the outcomes of users of pattern recognition to the outcomes of users without
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Home Study of an Advanced Upper Limb Prosthesis|
|Actual Study Start Date :||April 1, 2012|
|Actual Primary Completion Date :||December 19, 2017|
|Estimated Study Completion Date :||June 30, 2018|
Subjects with upper limb amputation
Device: Advanced upper limb prosthetic device
There are three versions of the advanced upper limb prosthetic device: shoulder configuration (SC, also known as shoulder disarticulation (SD)); humeral configuration (HC also known as transhumeral (TH)) and radial configuration (RC also known as transradial (TR)).
Other Name: DEKA Arm, DARPA Arm
- Change in Quality of Life (QOL) scale [ Time Frame: baseline and after 13 weeks of home use ]The QOL consists of 16 questions that assess satisfaction with independent living and self-care activities
- Home Use Appropriateness [ Time Frame: Up to 6 Weeks of in lab use ]Performance based criteria (developed for this study) relating to skillfulness of prosthetic use, independence in daily device maintenance and storage, and safety awareness.
- Extent of Prosthetic Use [ Time Frame: 2 weeks prior to in-laboratory training, and daily throughout the home usage portion of the study ]Daily logs (developed for this study) detailing usage of current prostheses and the advanced prosthetic device.
- Trinity Amputations and Prosthetics Experience Scale (TAPES) [ Time Frame: Baseline, Visit 14, Up to 6 Weeks of in lab use, Bi-Weekly (throughout the home usage portion of the study), After 13 weeks of home use ]The TAPES Satisfaction scale is a 10 item scale which includes questions about extent of satisfaction regarding functional characteristics of the artificial limb: reliability, comfort, fit, and overall satisfaction, contentment with cosmetic characteristics of the device.
- Activities Measure for Upper limb amputees (AM-ULA) [ Time Frame: Baseline, Visit 14, Up to 6 Weeks of in lab use, Bi-Weekly (throughout the home usage portion of the study), After 13 weeks of home use ]The AM-ULA is a new 18 item observational measure that assesses key elements of functional performance with a prosthesis: ability of the amputee to complete daily activities, speed of the performance, movement quality, skillfulness of prosthetic use and independence.
- SF-36 V [ Time Frame: Baseline, Visit 14, Up to 6 Weeks of in lab use, Bi-Weekly (throughout the home usage portion of the study), After 13 weeks of home use ]Four scales of the SF-36V will be used to assess quality of life: Role Physical, Role Emotional, Social Functioning, and Physical Functioning
- Neuropsychological Testing Battery [ Time Frame: Baseline ]The battery is comprised of following tests: Color-Word Interference and Verbal Fluency from the Delis-Kaplan Executive Function System (D-KEFS), Judgment of Line Orientation (JLO), Digit Span and Letter-Number Sequencing subtests from the Wechsler Adult Intelligence Scale - IV (WAIS-IV), oral versions of the Trail Making Test parts A & B, Symbol-Digit Modalities Test, Shape Learning and Shape Recall items from the Screening Module of the Neuropsychological Assessment Battery (NAB), and several components of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).
- Wong-Baker FACES Pain Rating Scale (FACES) [ Time Frame: Baseline, Visit 14, Up to 6 Weeks of in lab use, Bi-Weekly (throughout the home usage portion of the study), After 13 weeks of home use ]The FACES is a 6-point pain scale that utilizes faces to indicate the intensity of pain. The subject is asked to choose the face that best describes how he/she is feeling.
- Jebsen-Taylor Hand Function Test (JTHFT) [ Time Frame: Baseline, Visit 14, Up to 6 Weeks of in lab use, Monthly (throughout the home usage portion of the study) ]This seven-part test evaluates the time needed to perform 7 hand-related tasks including: 1) printing a 24-letter, third-grade reading difficulty sentence, 2) turning over 7.6 x 12.7 cm (3x5") cards in simulated page turning, 3) picking up small common objects including pennies, paper clips, bottle caps and placing them in a container, 4) stacking checkers, 5) simulated feeding, 6) moving large empty cans and 7) moving large 1 lb. cans.
- University of New Brunswick Test of Prosthetic Function (UNB) [ Time Frame: Baseline, Visit 14, Up to 6 Weeks of in lab use, Monthly (throughout the home usage portion of the study) ]This test will be used for unilateral amputees only. The investigators will use a subtest which includes the following activities: wrapping a parcel, sewing a button on cloth, cutting meat, drying dishes, sweeping floor, and using a dustpan and brush.
- Adapted Rivermead Extended Activities Index (REAI) [ Time Frame: Baseline, Visit 14, Up to 6 Weeks of in lab use, Monthly (throughout the home usage portion of the study) ]The investigators will utilize selected items from the REAI, a performance based instrumental activity measure that is scored on a three-point scale: 1, dependent; 2, independent but requires verbal supervision; and 3, independent. The investigators will also add a timed element to the testing procedures.
- Upper Extremity Functional Scale (UEFS) from the Orthotics and Prosthetics Users Survey (OPUS) [ Time Frame: Visit 14, Up to 6 Weeks of in lab use, Bi-Weekly (throughout the home usage portion of the study), After 13 weeks of home use ]The UEFS is a self-report measure developed for use with upper limb adult amputees. It includes 23 activities: self-care, instrumental, and daily living tasks using a 5-point scale from 0- cannot perform the activity to 4-very difficult.
- The Patient Specific Functional Scale (PSFS) [ Time Frame: Baseline, Visit 14, Up to 6 Weeks of in lab use, Bi-Weekly (throughout the home usage portion of the study), After 13 weeks of home use ]The PSFS is a patient-specific outcome measure to assess functional status. Subjects identify up to five activities that they have difficulty performing due to their condition and then rate the amount of limitation they have in performing on a scale of 0 to 10 with 0 being unable to perform the activity and 10 being able to perform the activity with no problem.
- The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT) [ Time Frame: Baseline, Visit 14, Up to 6 Weeks of in lab use, Bi-Weekly (throughout the home usage portion of the study), After 13 weeks of home use ]The CRIS measures community reintegration of Veterans, using the construction of participation. It consists of three scales which assess three different dimensions of community integration, extent and frequency, perceived limitations, and satisfaction.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01551420
|United States, Florida|
|James A. Haley Veterans' Hospital, Tampa, FL|
|Tampa, Florida, United States, 33612|
|United States, New York|
|Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY|
|New York, New York, United States, 10010|
|United States, Rhode Island|
|Providence VA Medical Center, Providence, RI|
|Providence, Rhode Island, United States, 02908|
|United States, Texas|
|Center for the Intrepid/ Brooke Army Medical Center|
|San Antonio, Texas, United States, 78234|
|Principal Investigator:||Linda J Resnik, PhD MS||Providence VA Medical Center, Providence, RI|