Traumatic Amputation of ArmNCT01551420
Home Study of an Advanced Upper Limb Prosthesis
A study of Traumatic Amputation of Arm, run by VA Office of Research and Development at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Amputation of Arm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Apr 2012to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Completion of all Part A study activities.
- Meets all criteria for Preliminary Determination of Appropriateness for Unsupervised, Home Device Use.
Who cannot join
- 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 would impair the ability to see the prosthesis and those who have major communication or neurocognitive deficits will be excluded.
- Persons with skin conditions such as burns or poor skin coverage as well as those with severe contractures that prevented prior prosthetic wear will be excluded.
- Persons with electrically controlled medical devices including pacemakers, and implanted defibrillators will be excluded.
- Persons with neuropathy, uncontrolled diabetes, who are receiving dialysis, have insensate feet, severe phantom pain or a history of skin ulcers or any other significant comorbidity which would interfere with the study will be excluded.
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- Those with severe circulatory problems including peripheral vascular disease and pitting edema will be excluded.
- Persons with cognitive deficits or mental health problems that would limit their ability to participate fully in the study protocol will be excluded.
- Women who are pregnant or who plan to become pregnant in the near future will also be excluded.
- The investigators will exclude those amputees who work for prosthetic companies that may be considered competitors for the prosthetic arm technology in the future.
- Persons taking medication which poses a risk for operation of heavy equipment will be excluded.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
New York, New York, 10010
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, 02908
Center for the Intrepid/ Brooke Army Medical Center
San Antonio, Texas, 78234
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, 33612
About this study
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.
Read the detailed description
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.
- Conditions
- Traumatic Amputation of Arm
- Being tested
- Advanced upper limb prosthetic device IMU controlled, Advanced upper limb prosthetic EMG-PR controlled
- Keywords
- Amputation, Prosthetic Design, Upper Extremity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced upper limb prosthetic device IMU controlledDevice
Also called DEKA Arm, DARPA Arm IMU controlled
Advanced upper limb prosthetic IMU controlled
Advanced upper limb prosthetic EMG-PR controlledDevice
Also called DEKA Arm, DARPA Arm EMG-PR controlled
Advanced upper limb prosthetic EMG-PR controlled
| Study group | Role | What they receive |
|---|---|---|
| Advanced upper limb prosthetic device IMU controlled | Active comparator | Subjects with upper limb amputation who are trained to use a DEKA Arm with IMU controls Receives: Device: Advanced upper limb prosthetic device IMU controlled |
| Advanced upper limb prosthetic EMG-PR controlled | Active comparator | Subjects with TR or TH upper limb amputation who are trained to use a DEKA Arm with EMG-PR Controls Receives: Device: Advanced upper limb prosthetic EMG-PR controlled |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life (QOL) Scale
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.
Measured: baseline and after 9-12 weeks of home use (end of Part B)
Secondary outcomes (9)
Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS) Use Scale
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.
Measured: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)
Trinity Amputations and Prosthetics Experience Scale (TAPES) Satisfaction Scale
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.
Measured: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)
Activities Measure for Upper Limb Amputees (AM-ULA)
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).
Measured: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)
Three Scales of the Veterans Version of the SF-36
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.
Measured: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)
Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests
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.
Measured: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)
University of New Brunswick Test of Prosthetic Function (UNB)
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 0 to 4 with higher scores reflecting higher spontaneity and skill.
Measured: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)
Timed Measure of Activity Performance (T-MAP)
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
Measured: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)
Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS)
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.
Measured: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)
The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT)
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.
Measured: Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study start1 Apr 2012
- Primary completion19 Dec 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Traumatic Amputation of ArmStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Sequential testing in non-equivalent comparison groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01551420
- Sponsor's protocol ID
- A0771-R
- Other IDs
- A9226-R
- Status last verified
- Apr 2019
- First submitted
- 27 Feb 2012
- Last updated
- 30 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Resnik L, Borgia M, Acluche F. Brief activity performance measure for upper limb amputees: BAM-ULA. Prosthet Orthot Int. 2018 Feb;42(1):75-83. doi: 10.1177/0309364616684196. Epub 2017 Jan 16.
PubMed 28091278Resnik L, Borgia M, Acluche F. Timed activity performance in persons with upper limb amputation: A preliminary study. J Hand Ther. 2017 Oct-Dec;30(4):468-476. doi: 10.1016/j.jht.2017.03.008. Epub 2017 May 6.
PubMed 28487130Resnik LJ, Borgia ML, Acluche F. Perceptions of satisfaction, usability and desirability of the DEKA Arm before and after a trial of home use. PLoS One. 2017 Jun 2;12(6):e0178640. doi: 10.1371/journal.pone.0178640. eCollection 2017.
PubMed 28575025Resnik L, Fantini C, Latlief G, Phillips S, Sasson N, Sepulveda E. Use of the DEKA Arm for amputees with brachial plexus injury: A case series. PLoS One. 2017 Jun 19;12(6):e0178642. doi: 10.1371/journal.pone.0178642. eCollection 2017.
PubMed 28628623Resnik L, Acluche F, Borgia M. The DEKA hand: A multifunction prosthetic terminal device-patterns of grip usage at home. Prosthet Orthot Int. 2018 Aug;42(4):446-454. doi: 10.1177/0309364617728117. Epub 2017 Sep 15.
PubMed 28914583Resnik L, Acluche F, Lieberman Klinger S, Borgia M. Does the DEKA Arm substitute for or supplement conventional prostheses. Prosthet Orthot Int. 2018 Oct;42(5):534-543. doi: 10.1177/0309364617729924. Epub 2017 Sep 14.
PubMed 28905665Resnik L, Klinger S. Attrition and retention in upper limb prosthetics research: experience of the VA home study of the DEKA arm. Disabil Rehabil Assist Technol. 2017 Nov;12(8):816-821. doi: 10.1080/17483107.2016.1269212. Epub 2017 Jan 18.
PubMed 28098513Resnik, L. Cancio, J. Fantini, C. Ikeda, A. Sasson, N. Pattern Recognition Control of the DEKA Arm in Two Transhumeral Amputees with Target Muscle Reinnervation, Conference Proceedings, Myoelectric Control Conference (MEC), 2017
Resnik L, Cancio J, Klinger S, Latlief G, Sasson N, Smurr-Walters L. Predictors of retention and attrition in a study of an advanced upper limb prosthesis: implications for adoption of the DEKA Arm. Disabil Rehabil Assist Technol. 2018 Feb;13(2):206-210. doi: 10.1080/17483107.2017.1304585. Epub 2017 Apr 4.
PubMed 28375687Resnik LJ, Borgia ML, Acluche F, Cancio JM, Latlief G, Sasson N. How do the outcomes of the DEKA Arm compare to conventional prostheses? PLoS One. 2018 Jan 17;13(1):e0191326. doi: 10.1371/journal.pone.0191326. eCollection 2018.
PubMed 29342217Resnik L, Klinger S, Gill A, Ekerholm Biester S. Feminine identity and functional benefits are key factors in women's decision making about upper limb prostheses: a case series. Disabil Rehabil Assist Technol. 2019 Feb;14(2):194-208. doi: 10.1080/17483107.2018.1467973. Epub 2018 May 9.
PubMed 29741966Resnik L, Acluche F, Borgia M, Cancio J, Latlief G, Sasson N. Function, quality of life, and community integration of DEKA Arm users after discharge from prosthetic training: Impact of home use experience. Prosthet Orthot Int. 2018 Dec;42(6):571-582. doi: 10.1177/0309364618774054. Epub 2018 May 19.
PubMed 29779455Resnik LJ, Acluche F, Lieberman Klinger S. User experience of controlling the DEKA Arm with EMG pattern recognition. PLoS One. 2018 Sep 21;13(9):e0203987. doi: 10.1371/journal.pone.0203987. eCollection 2018.
PubMed 30240420Resnik LJ, Acluche F, Borgia M, Cancio J, Latlief G, Phillips S, Sasson N. EMG pattern recognition compared to foot control of the DEKA Arm. PLoS One. 2018 Oct 18;13(10):e0204854. doi: 10.1371/journal.pone.0204854. eCollection 2018.
PubMed 30335781
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Study of an Advanced Upper Limb Prosthesis
- ClinicalTrials.gov ID
- NCT01551420
- Acronym / sponsor ID
- A0771-R
- Conditions
- Traumatic Amputation of Arm
- Keywords
- Amputation, Prosthetic Design, Upper Extremity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Apr 2012 (actual)
- Primary completion
- 19 Dec 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 12 Mar 2012 (estimated)
- Results
- Posted 30 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Sequential testing in non-equivalent comparison groups
| Arm | Type | Receives |
|---|---|---|
| Advanced upper limb prosthetic device IMU controlled | Active comparator | Device: Advanced upper limb prosthetic device IMU controlledSubjects with upper limb amputation who are trained to use a DEKA Arm with IMU controls |
| Advanced upper limb prosthetic EMG-PR controlled | Active comparator | Device: Advanced upper limb prosthetic EMG-PR controlledSubjects with TR or TH upper limb amputation who are trained to use a DEKA Arm with EMG-PR Controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Completion of all Part A study activities.
Key exclusion criteria (11 listed)
- 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 would impair the ability to see the prosthesis and those who have major communication or neurocognitive deficits will be excluded.
- Persons with skin conditions such as burns or poor skin coverage as well as those with severe contractures that prevented prior prosthetic wear will be excluded.
- Persons with electrically controlled medical devices including pacemakers, and implanted defibrillators will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advanced upper limb prosthetic device IMU controlledAlso: DEKA Arm, DARPA Arm IMU controlledAdvanced upper limb prosthetic IMU controlled | Device | Advanced upper limb prosthetic device IMU controlled |
| Advanced upper limb prosthetic EMG-PR controlledAlso: DEKA Arm, DARPA Arm EMG-PR controlledAdvanced upper limb prosthetic EMG-PR controlled | Device | Advanced upper limb prosthetic EMG-PR controlled |
Primary outcome
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 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.
9 secondary outcomes
Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS) Use Scale
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)
Trinity Amputations and Prosthetics Experience Scale (TAPES) Satisfaction Scale
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)
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)
Three Scales of the Veterans Version of the SF-36
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)
Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests
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)
University of New Brunswick Test of Prosthetic Function (UNB)
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)
Timed Measure of Activity Performance (T-MAP)
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)
Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS)
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 Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28091278Resnik L, Borgia M, Acluche F. Brief activity performance measure for upper limb amputees: BAM-ULA. Prosthet Orthot Int. 2018 Feb;42(1):75-83. doi: 10.1177/0309364616684196. Epub 2017 Jan 16.
- Background: PubMed 28487130Resnik L, Borgia M, Acluche F. Timed activity performance in persons with upper limb amputation: A preliminary study. J Hand Ther. 2017 Oct-Dec;30(4):468-476. doi: 10.1016/j.jht.2017.03.008. Epub 2017 May 6.
- Background: PubMed 28575025Resnik LJ, Borgia ML, Acluche F. Perceptions of satisfaction, usability and desirability of the DEKA Arm before and after a trial of home use. PLoS One. 2017 Jun 2;12(6):e0178640. doi: 10.1371/journal.pone.0178640. eCollection 2017.
- Background: PubMed 28628623Resnik L, Fantini C, Latlief G, Phillips S, Sasson N, Sepulveda E. Use of the DEKA Arm for amputees with brachial plexus injury: A case series. PLoS One. 2017 Jun 19;12(6):e0178642. doi: 10.1371/journal.pone.0178642. eCollection 2017.
- Background: PubMed 28914583Resnik L, Acluche F, Borgia M. The DEKA hand: A multifunction prosthetic terminal device-patterns of grip usage at home. Prosthet Orthot Int. 2018 Aug;42(4):446-454. doi: 10.1177/0309364617728117. Epub 2017 Sep 15.
- Background: PubMed 28905665Resnik L, Acluche F, Lieberman Klinger S, Borgia M. Does the DEKA Arm substitute for or supplement conventional prostheses. Prosthet Orthot Int. 2018 Oct;42(5):534-543. doi: 10.1177/0309364617729924. Epub 2017 Sep 14.
- Background: PubMed 28098513Resnik L, Klinger S. Attrition and retention in upper limb prosthetics research: experience of the VA home study of the DEKA arm. Disabil Rehabil Assist Technol. 2017 Nov;12(8):816-821. doi: 10.1080/17483107.2016.1269212. Epub 2017 Jan 18.
- BackgroundResnik, L. Cancio, J. Fantini, C. Ikeda, A. Sasson, N. Pattern Recognition Control of the DEKA Arm in Two Transhumeral Amputees with Target Muscle Reinnervation, Conference Proceedings, Myoelectric Control Conference (MEC), 2017
- Results publication: PubMed 28375687Resnik L, Cancio J, Klinger S, Latlief G, Sasson N, Smurr-Walters L. Predictors of retention and attrition in a study of an advanced upper limb prosthesis: implications for adoption of the DEKA Arm. Disabil Rehabil Assist Technol. 2018 Feb;13(2):206-210. doi: 10.1080/17483107.2017.1304585. Epub 2017 Apr 4.
- Results publication: PubMed 29342217Resnik LJ, Borgia ML, Acluche F, Cancio JM, Latlief G, Sasson N. How do the outcomes of the DEKA Arm compare to conventional prostheses? PLoS One. 2018 Jan 17;13(1):e0191326. doi: 10.1371/journal.pone.0191326. eCollection 2018.
- Results publication: PubMed 29741966Resnik L, Klinger S, Gill A, Ekerholm Biester S. Feminine identity and functional benefits are key factors in women's decision making about upper limb prostheses: a case series. Disabil Rehabil Assist Technol. 2019 Feb;14(2):194-208. doi: 10.1080/17483107.2018.1467973. Epub 2018 May 9.
- Results publication: PubMed 29779455Resnik L, Acluche F, Borgia M, Cancio J, Latlief G, Sasson N. Function, quality of life, and community integration of DEKA Arm users after discharge from prosthetic training: Impact of home use experience. Prosthet Orthot Int. 2018 Dec;42(6):571-582. doi: 10.1177/0309364618774054. Epub 2018 May 19.
- Individual participant dataSharing planned: No
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Medical Economic Evaluation of Bilateral Allograft of Hands and Forearms
Bilateral Traumatic Amputation of Upper Limbs
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Traumatic Amputation of Arm, run by VA Office of Research and Development at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life (QOL) Scale (time frame: baseline and after 9-12 weeks of home use (end of Part B)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01551420, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2019.