CompletedNAResults postedLast updated 30 April 2019
What this trial tests
NA trial testing Advanced upper limb prosthetic device IMU controlled in Traumatic Amputation of Arm in 52 participants. Completed in 31 December 2018.
18 and older, any sex, with Traumatic Amputation of Arm. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Quality of Life (QOL) ScalePrimary· 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 average of these 16 items is the summary score with higher values reflecting higher satisfaction. The primary outcome is the net 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 ScaleSecondary· Baseline, end of Part A (variable time frame depending on training schedule), 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 of activities performed using a prosthesis.
Trinity Amputations and Prosthetics Experience Scale (TAPES) Satisfaction ScaleSecondary· Baseline, end of Part A (variable time frame depending on training schedule), 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)Secondary· 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 and has a range from 0 (lowest functional performance) to 40 (highest functional performance).
Three Scales of the Veterans Version of the SF-36Secondary· Baseline, end of Part A (variable time frame depending on training schedule), 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
Jebsen-Taylor Hand Function Test (JTHFT) 7 SubtestsSecondary· Baseline, end of Part A (variable time frame depending on training schedule), 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 mov
University of New Brunswick Test of Prosthetic Function (UNB)Secondary· Baseline, end of Part A (variable time frame depending on training schedule), 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. Each task was rated for both spontaneity and skill. 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 by averaging items and range from
Timed Measure of Activity Performance (T-MAP)Secondary· Baseline, end of Part A (variable time frame depending on training schedule), 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 completion of activity is measured and summed to obtain overall timed score. Lower overall scores (less time taken) indicate better / faster activity performance
Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS)Secondary· Baseline, end of Part A (variable time frame depending on training schedule), 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 and ranged from 0 to 100 with lower scores reflecting better function.
The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT)Secondary· Baseline, end of Part A (variable time frame depending on training schedule), 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.
Time frame: Adverse event data were collected non-systematically as events were reported. They were also summarized at annual IRB continuing reviews from baseline to after 9-12 weeks of home use..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 30 April 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01551420.