Home Study of an Advanced Upper Limb Prosthesis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01551420|
Recruitment Status : Active, not recruiting
First Posted : March 12, 2012
Last Update Posted : December 10, 2018
|Condition or disease||Intervention/treatment|
|Traumatic Amputation of Arm||Device: Advanced upper limb prosthetic device IMU controlled Device: Advanced upper limb prosthetic EMG-PR controlled|
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|
|Actual Enrollment :||52 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 :||December 31, 2018|
Advanced upper limb prosthetic device IMU controlled
Subjects with upper limb amputation who are trained to use a DEKA Arm with IMU controls
Device: Advanced upper limb prosthetic device IMU controlled
Advanced upper limb prosthetic IMU controlled
Other Name: DEKA Arm, DARPA Arm IMU controlled
Advanced upper limb prosthetic EMG-PR controlled
Subjects with TR or TH upper limb amputation who are trained to use a DEKA Arm with EMG-PR Controls
Device: Advanced upper limb prosthetic EMG-PR controlled
Advanced upper limb prosthetic EMG-PR controlled
Other Name: DEKA Arm, DARPA Arm EMG-PR controlled
- Change in Quality of Life (QOL) scale [ Time Frame: baseline and after 9-12 weeks of home use (end of Part B) ]The QOL consists of 16 questions that assess satisfaction with independent living and self-care activities. Each item is rated (1=Terrible to 7=Delighted). The primary outcome is the change in summary score between baseline and end of Part B.
- Upper Extremity Functional Scale (UEFS) from the Orthotics and Prosthetics Users Survey (OPUS) Use scale [ Time Frame: Baseline, at completion of Part A training (an average of 51.1 days), after 9-12 weeks of home use (end of Part B). ]Measures the engagement of the prosthesis in everyday activities using 23 items from the OPUS UEFS. Respondents indicate which activities they performed using a prosthesis. The score is the proportion (0 to 1) of activities performed using a prosthesis. Higher proportions indicate more items completed with a prosthesis.
- Trinity Amputations and Prosthetics Experience Scale (TAPES) Satisfaction Scale [ Time Frame: Baseline, at completion of Part A training (an average of 51.1 days), after 9-12 weeks of home use (end of Part B). ]The TAPES Satisfaction scale is a 10-item scale measuring extent of satisfaction regarding functional characteristics of the artificial limb: reliability, comfort, fit, and overall satisfaction, contentment with cosmetic characteristics of the device. Each item is rated from 1-5 (1=Very Dissatisfied to 5=Very Satisfied). The average score is used.
- Activities Measure for Upper limb amputees (AM-ULA) [ Time Frame: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B) ]The AM-ULA is an 18-item measure assessing 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. Items are rated 0=Unable to perform task to 4=Excellent Performance. Average score is multiplied by 10.
- Three scales of the Veterans Version of the SF-36 [ Time Frame: Baseline, at completion of Part A training (an average of 51.1 days), after 9-12 weeks of home use (end of Part B). ]Role Physical: measures role physical function with 4 items referring to role limitations due to physical health. Items are rated from 1=none of the time to 5=All of the time. Social Functioning: measures social functioning with 2 items referring to problems interfering with socializing with friends and family. One item is rated extent of problems as 1=Not at all to 5=Extremely and is reverse coded. All other items are rated as problem frequency from 1=All of the time to 5=None of the time. The mean score is scaled to range between 0 to 100. Physical Functioning: measures physical functioning with 10 items pertaining to moving, lifting and walking. Items are rated from 1=Limited a lot to 3=Not limited at all. The mean score is scaled to range between 0 to 100. In all scales, higher scores correspond to higher quality of life.
- Jebsen-Taylor Hand Function Test (JTHFT) 7 subtests [ Time Frame: Baseline, at completion of Part A training (an average of 51.1 days), after 9-12 weeks of home use (end of Part B). ]JTHFT Writing: Evaluates the time needed to print a 24-letter, third-grade reading difficulty sentence. JTHFT Page turning: Evaluates the time needed to turn over 7.6 x 12.7 cm (3x5") cards in simulated page turning. JTHFT Small objects: Evaluates the time needed to perform pick up small common objects including pennies, paper clips, bottle caps and placing them in a container. JTHFT Stacking checkers: Evaluates the time needed to stack four checkers. JTHFT Simulated feeding: Evaluates the time needed to perform simulated feeding. JTHFT Moving large empty cans: Evaluates the time needed to move large empty cans. JTHFT Moving large 1 lb. cans: Evaluates the time needed to move 1 lb. cans. All subtests are modified to cap the maximal time for the subtask at 120 seconds and is scored as the number of items completed per second.
- University of New Brunswick Test of Prosthetic Function (UNB) [ Time Frame: Baseline, at completion of Part A training (an average of 51.1 days), after 9-12 weeks of home use (end of Part B). ]This test is performed with unilateral amputees only. The subtest used includes wrapping a parcel, sewing a button on cloth, cutting meat, drying dishes, sweeping floor, and using a dustpan and brush. UNB Spontaneity: Spontaneity rates spontaneity of prosthesis use (0=prosthesis not used to 4=immediate, consistent use of terminal device. UNB Skill: rates skill of performing the activities (0 = prothesis not used to 4 = active terminal device is quick & smooth). Summary scores are calculated for each subscale.
- Timed Measure of Activity Performance (T-MAP) [ Time Frame: Baseline, at completion of Part A training (an average of 51.1 days), after 9-12 weeks of home use (end of Part B). ]The T-MAP is a performance measure of daily activities for persons with upper limb amputation utilizing 5 every day activities. Time (seconds) to complete activity is measured and summed to obtain overall timed score.
- Upper Extremity Functional Scale (UEFS) from the Orthotics and Prosthetics Users Survey (OPUS) [ Time Frame: Baseline, at completion of Part A training (an average of 51.1 days), after 9-12 weeks of home use (end of Part B). ]The UEFS is a self-report measure developed for use with upper limb adult amputees. It includes 23 activities: selfcare, instrumental, and daily living tasks using a 5-point scale from 1=Very Easy to 5=Cannot perform. Total score was calculated using IRT methods.
- The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT) [ Time Frame: Baseline, at completion of Part A training (an average of 51.1 days), after 9-12 weeks of home use (end of Part B). ]The CRIS measures community reintegration. It consists of three scales extent and frequency, perceived limitations, and satisfaction. Higher scores (range 0-100) indicate better community integration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|