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| ID | Type | Description | Link |
|---|---|---|---|
| A9226-R | Other Grant/Funding Number | VA RR&D |
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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.
The specific objectives of this study are to:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Advanced upper limb prosthetic device IMU controlled | Device | Advanced upper limb prosthetic IMU controlled |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline and after 9-12 weeks of home use (end of Part B) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B) |
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Inclusion Criteria:
Inclusion Criteria (Parts A and B):
Inclusion Criteria Part B only:
Exclusion Criteria:
Exclusion Criteria (Parts A and B):
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James A. Haley Veterans' Hospital, Tampa, FL | Tampa | Florida | 33612 | United States | ||
| Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28091278 | Background | 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. | |
| 28487130 | Background | Resnik 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Advanced Upper Limb Prosthetic Device IMU Controlled | Subjects with upper limb amputation who are trained to use a DEKA Arm with IMU controls Advanced upper limb prosthetic device IMU controlled: Advanced upper limb prosthetic IMU controlled |
| FG001 | 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 Advanced upper limb prosthetic EMG-PR controlled: Advanced upper limb prosthetic EMG-PR controlled |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| In-laboratory (Part A) |
|
| |||||||||||||||||||||
| Screened for Part B Eligibility |
| ||||||||||||||||||||||
| Home Use (Part B) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Advanced Upper Limb Prosthetic Device IMU Controlled | Subjects with upper limb amputation who are trained to use a DEKA Arm with IMU controls Advanced upper limb prosthetic device IMU controlled: Advanced upper limb prosthetic IMU controlled |
| BG001 | Advanced Upper Limb Prosthetic EMG-PR Controlled |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline and after 9-12 weeks of home use (end of Part B) |
|
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.
Definitions of adverse events are consistent with clinicaltrials.gov definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Advanced Upper Limb Prosthetic Device IMU Controlled | Subjects with upper limb amputation who are trained to use a DEKA Arm with IMU controls Advanced upper limb prosthetic device IMU controlled: Advanced upper limb prosthetic IMU controlled |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unrelated adverse event | Skin and subcutaneous tissue disorders | Unrelated Event | Non-systematic Assessment | Subject hospitalized due to an unrelated cellulitis flare-up in his lower limb |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda Resnik, Research Career Scientist | Providence VA Medical Center | 401-273-7100 | 2368 | Linda.Resnik@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 16, 2017 | Apr 8, 2019 | Prot_SAP_000.pdf |
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Sequential testing in non-equivalent comparison groups
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| Advanced upper limb prosthetic EMG-PR controlled | Device | Advanced upper limb prosthetic EMG-PR controlled |
|
|
| 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. | 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). | 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. | 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. | 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. | 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 | 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. | 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. | Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B) |
| New York |
| New York |
| 10010 |
| United States |
| Providence VA Medical Center, Providence, RI | Providence | Rhode Island | 02908 | United States |
| Center for the Intrepid/ Brooke Army Medical Center | San Antonio | Texas | 78234 | United States |
| 28575025 | Background | Resnik 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. |
| 28628623 | Background | Resnik 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. |
| 28914583 | Background | Resnik 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. |
| 28905665 | Background | Resnik 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. |
| 28098513 | Background | Resnik 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. |
| Background | Resnik, 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 |
| 28375687 | Result | 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. |
| 29342217 | Result | Resnik 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. |
| 29741966 | Result | Resnik 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. |
| 29779455 | Result | Resnik 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. |
| 30240420 | Result | Resnik 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. |
| 30335781 | Result | Resnik 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. |
| Scheduling conflict |
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| NOT COMPLETED |
|
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| NOT COMPLETED |
|
|
Subjects with TR or TH upper limb amputation who are trained to use a DEKA Arm with EMG-PR Controls Advanced upper limb prosthetic EMG-PR controlled: Advanced upper limb prosthetic EMG-PR controlled |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Subjects with TR or TH upper limb amputation who are trained to use a DEKA Arm with EMG-PR Controls Advanced upper limb prosthetic EMG-PR controlled: Advanced upper limb prosthetic EMG-PR controlled |
|
|
|
| Secondary | 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. | Prosthesis users only, at baseline, completers at End of A and End of B. | Posted | Mean | Standard Deviation | proportion of activities performed | Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B) |
|
|
|
|
| Secondary | 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. | Prosthesis users only, at baseline, completers at End of A and End of B. | Posted | Mean | Standard Deviation | score on a scale | Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B) |
|
|
|
|
| Secondary | 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). | Prosthesis users only, at baseline, completers at End of A and End of B. | Posted | Mean | Standard Deviation | units on a scale | Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B) |
|
|
|
|
| Secondary | 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. | Baseline participants and completers at End of A and End of B | Posted | Mean | Standard Deviation | score on a scale | Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B) |
|
|
|
|
| Secondary | 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. | Prosthesis users only, at baseline, completers at End of A and End of B. | Posted | Mean | Standard Deviation | items completed per second | Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B) |
|
|
|
|
| Secondary | 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. | Prosthesis users only, at baseline, completers at End of A and End of B. | Posted | Mean | Standard Deviation | score on a scale | Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B) |
|
|
|
|
| Secondary | 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 | Baseline participants and completers at End of A and End of B | Posted | Mean | Standard Deviation | Seconds | Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B) |
|
|
|
|
| Secondary | 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. | Baseline participants and completers at End of A and End of B. | Posted | Mean | Standard Deviation | score on a scale | Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B) |
|
|
|
|
| Secondary | 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. | Baseline participants and completers at End of A and End of B | Posted | Mean | Standard Deviation | score on a scale | Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B) |
|
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 5 |
| 39 |
| EG001 | 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 Advanced upper limb prosthetic EMG-PR controlled: Advanced upper limb prosthetic EMG-PR controlled | 0 | 13 | 0 | 13 | 1 | 13 |
|
| Unrelated adverse event | Injury, poisoning and procedural complications | Car accident | Non-systematic Assessment | Subject was in a car accident in a rental car on his way to the airport after the study had ended |
|
| Adverse Event | Skin and subcutaneous tissue disorders | Skin irritation | Non-systematic Assessment | Subject had a skin irritation, possibly due to socket wear |
|
| Adverse event | Musculoskeletal and connective tissue disorders | Musculoskeletal pain | Non-systematic Assessment | Musculoskeletal pain related to wearing or using the device: including back or ankle pain |
|
| Adverse event | Injury, poisoning and procedural complications | Injury | Non-systematic Assessment | Subject was using the prosthesis to eat with a fork and sustained a minor cut to his lip. |
|
Not provided
Not provided
| Completers End of Part A |
|
|
| Completers End of B |
|
|
| Linear regression of scores from UEFS use measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis. | Regression, Linear | The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for UEFS at End of Part B. | <0.0001 | Slope | -0.56 | Standard Error of the Mean | 0.08 | 2-Sided | 95 | -0.73 | -0.40 | Effect of EMG-PR (compared to IMU group) | Superiority |
| Completers End of Part A |
|
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| Completers End of B |
|
|
| Linear regression of scores from TAPES measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis. | Regression, Linear | The sample for this analysis was 24 participants with TR or TH amputation level who completed data collection for TAPES at End of Part B. | 0.0168 | Slope | -1.15 | Standard Error of the Mean | 0.44 | 2-Sided | 95 | -2.06 | -0.23 | Effect of EMG-PR (compared to IMU group) | Superiority |
| Completers End of Part A |
|
|
| Completers End of B |
|
|
| Linear regression of scores from AM-ULA measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis. | Regression, Linear | The sample for this analysis was 22 participants with TR or TH amputation level who completed data collection for UEFS at End of Part B. | 0.6339 | Slope | -0.72 | Standard Error of the Mean | 1.49 | 2-Sided | 95 | -3.84 | 2.39 | Effect of EMG-PR (compared to IMU group) | Superiority |
| Role Physical:Completers at End of Part A |
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| Role Physical: Completers at End of B |
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| Social Functioning: Participants at Baseline |
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| Social Functioning: Completers at End of Part A |
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| Social Functioning: Completers End of B |
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| Physical Functioning: Participants at Baseline |
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| Physical Functioning: Completers at End of Part A |
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| Physical Functioning: Completers at End of B |
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| Pairwise t-test for data for participants at baseline to End of A (with SF-36V Social Functioning data at both time points). | t-test, 2 sided | The sample for this paired t-test was 43 participants. | 0.1610 | Mean Difference (Net) | -3.78 | Standard Deviation | 17.37 | 2-Sided | 95 | -9.12 | 1.57 | Mean difference is the change in scores from baseline to End of A. | Superiority |
| Pairwise t-test for data for participants at baseline to End of A (with SF-36V Physical Functioning data at both time points). | t-test, 2 sided | The sample for this paired t-test was 43 participants. | 0.7765 | Mean Difference (Net) | -0.61 | Standard Deviation | 13.9 | 2-Sided | 95 | -4.90 | 3.68 | Mean difference is the change in scores from baseline to End of A. | Superiority |
| Linear regression of SF-36V; Role Physical measure at 9-12 weeks, comparing groups by control type, controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis. | Regression, Linear | The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for SF-36 at End of Part B. | 0.0669 | Slope | -13.35 | Standard Error of the Mean | 6.91 | 2-Sided | 95 | -27.72 | 1.02 | Effect of EMG-PR (compared to IMU group) | Superiority |
| Linear regression of SF-36V: Social Functioning measure at 9-12 weeks, comparing groups by control type, controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis. | Regression, Linear | The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for SF-36 at End of Part B. | 0.2592 | Slope | -8.24 | Standard Error of the Mean | 7.10 | 2-Sided | 95 | -23.01 | 6.54 | Effect of EMG-PR (compared to IMU group) | Superiority |
| Linear regression of SF-36V: Physical Functioning measure at 9-12 weeks, comparing groups by control type, controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis. | Regression, Linear | The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for SF-36 at End of Part B. | <0.0001 | Slope | -30.23 | Standard Error of the Mean | 6.25 | 2-Sided | 95 | -43.23 | -17.23 | Effect of EMG-PR (compared to IMU group) | Superiority |
| JTHFT Writing: Completers at End of Part A |
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| JTHFT Writing: Completers End of B |
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| JTHFT Page Turning: Prosthesis users at baseline |
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| JTHFT Page Turning: : Completers at End of Part A |
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| JTHFT Page Turning: Completers End of B |
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| JTHFT Small Items: Prosthesis users at baseline |
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| JTHFT Lifting Small Items:: Completers End of Part |
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| JTHFT Lifting Small Items: Completers End of B |
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| JTHFT Checkers: Prosthesis users at baseline |
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| JTHFT Checkers: Completers End of Part A |
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| JTHFT Checkers: Completers End of B |
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| JTHFT Feeding: Prosthesis users at baseline |
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| JTHFT Feeding: Completers End of Part A |
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| JTHFT Feeding: Completers End of B |
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| JTHFT Light Cans: Prosthesis users at baseline |
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| JTHFT Light Cans: Completers End of Part A |
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| JTHFT Light Cans: Completers End of B |
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| JTHFT Heavy Cans: Prosthesis users at baseline |
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| JTHFT Heavy Cans: Completers End of Part A |
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| JTHFT Heavy Cans: Completers End of B |
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| Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Page turning data at both time points). | t-test, 2 sided | The sample for this paired t-test was 31 participants. | 0.0511 | Mean Difference (Net) | -0.02 | Standard Deviation | 0.06 | 2-Sided | 95 | -0.05 | 0.00 | Mean difference is the change in scores from baseline to End of A. | Superiority |
| Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Lifting Small Items data at both time points). | t-test, 2 sided | The sample for this paired t-test was 31 participants. | 0.5942 | Mean Difference (Net) | 0.01 | Standard Deviation | 0.09 | 2-Sided | 95 | -0.02 | 0.04 | Mean difference is the change in scores from baseline to End of A. | Superiority |
| Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Checkers data at both time points). | t-test, 2 sided | The sample for this paired t-test was 31 participants. | 0.0101 | Mean Difference (Net) | -0.05 | Standard Deviation | 0.08 | 2-Sided | 95 | -0.07 | -0.01 | Mean difference is the change in scores from baseline to End of A. | Superiority |
| Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Feeding data at both time points). | t-test, 2 sided | The sample for this paired t-test was 31 participants. | 0.1063 | Mean Difference (Net) | -0.03 | Standard Deviation | 0.09 | 2-Sided | 95 | -0.06 | 0.01 | Mean difference is the change in scores from baseline to End of A. | Superiority |
| Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Light Cans data at both time points). | t-test, 2 sided | The sample for this paired t-test was 31 participants. | 0.2474 | Mean Difference (Net) | -0.03 | Standard Deviation | 0.12 | 2-Sided | 95 | -0.06 | 0.01 | Mean difference is the change in scores from baseline to End of A. | Superiority |
| Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Heavy Cans data at both time points). | t-test, 2 sided | The sample for this paired t-test was 31 participants. | 0.1604 | Mean Difference (Net) | -0.04 | Standard Deviation | 0.14 | 2-Sided | 95 | -0.09 | 0.02 | Mean difference is the change in scores from baseline to End of A. | Superiority |
| Linear regression of scores from JTHFT: Writing measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis. | Regression, Linear | The sample for this analysis was 24 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B. | 0.4208 | Slope | -0.06 | Standard Error of the Mean | 0.07 | 2-Sided | 95 | -0.12 | 0.09 | Effect of EMG-PR (compared to IMU group) | Superiority |
| Linear regression of scores from JTHFT: Page Turning measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis. | Regression, Linear | The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B. | 0.1959 | Slope | -0.04 | Standard Error of the Mean | 0.03 | 2-Sided | 95 | -0.09 | 0.02 | Effect of EMG-PR (compared to IMU group) | Superiority |
| Regression, Linear | The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B. | 0.3328 | Slope | -0.03 | Standard Error of the Mean | 0.03 | 2-Sided | 95 | -0.09 | 0.03 | Effect of EMG-PR (compared to IMU group) | Superiority | Linear regression of scores from JTHFT: Lifting Small Items measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis. |
| Linear regression of scores from JTHFT: Checkers measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis. | Regression, Linear | The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B. | 0.6585 | Slope | 0.01 | Standard Error of the Mean | 0.03 | 2-Sided | 95 | -0.05 | 0.08 | Effect of EMG-PR (compared to IMU group) | Superiority |
| Regression, Linear | The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B. | 0.0552 | Slope | -0.06 | Standard Error of the Mean | 0.03 | 2-Sided | 95 | -0.12 | 0.00 | Effect of EMG-PR (compared to IMU group) | Superiority | Linear regression of scores from JTHFT: Feeding measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis. |
| Linear regression of scores from JTHFT: Light Cans measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis. | Regression, Linear | The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B. | 0.0319 | Slope | -0.13 | Standard Error of the Mean | 0.06 | 2-Sided | 95 | -0.25 | -0.01 | Effect of EMG-PR (compared to IMU group) | Superiority |
| Linear regression of scores from JTHFT: Heavy Cans measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis. | Regression, Linear | The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B. | 0.0073 | Slope | -0.14 | Standard Error of the Mean | 0.05 | 2-Sided | 95 | -0.24 | -0.04 | Effect of EMG-PR (compared to IMU group) | Superiority |
| UNB Spontanaity: Completers End of Part A |
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| UNB Spontaneity: Completers End of Part B |
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| UNB Skill: Prosthesis users at baseline |
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| UNB Skill: Completers End of Part A |
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| UNB Skill: Completers End of Part B |
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| Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with UNB: Skill data at both time points). | t-test, 2 sided | The sample for this paired t-test was 30 participants. | 0.8490 | Mean Difference (Net) | -0.02 | Standard Deviation | 0.64 | 2-Sided | 95 | -0.26 | 0.22 | Mean difference is the change in scores from baseline to End of A. | Superiority |
| Linear regression of scores from UNB: Spontaneity measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis. | Regression, Linear | The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for UNB: Spontaneity at End of Part B. | 0.4589 | Slope | 0.13 | Standard Error of the Mean | 0.17 | 2-Sided | 95 | -0.22 | 0.48 | Effect of EMG-PR (compared to IMU group) | Superiority |
| Linear regression of scores from UNB: Skill measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis. | Regression, Linear | The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for UNB: Skill at End of Part B. | 0.7110 | Slope | 0.07 | Standard Error of the Mean | 0.18 | 2-Sided | 95 | -0.31 | 0.44 | Effect of EMG-PR (compared to IMU group) | Superiority |
| Completers End of Part A |
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| Completers End of Part B |
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| Linear regression of scores from T-MAP measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis. | Regression, Linear | The sample for this analysis was 22 participants with TR or TH amputation level who completed data collection for T-MAP at End of Part B. | 0.3397 | Slope | -183.1 | Standard Error of the Mean | 186.9 | 2-Sided | 95 | -574.3 | 208.2 | Effect of EMG-PR (compared to IMU group) | Superiority |
| Completers End of Part A |
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| Completers End of Part B |
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| Linear regression of scores from UEFS measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis. | Regression, Linear | The sample for this analysis was 19participants with TR or TH amputation level who completed data collection for UEFS at End of Part B. | 0.3450 | Slope | -2.39 | Standard Error of the Mean | 2.46 | 2-Sided | 95 | -7.60 | 2.82 | Effect of EMG-PR (compared to IMU group) | Superiority |
| CRIS Extent: Completers End of Part A |
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| CRIS Extent: Completers End of Part B |
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| CRIS Perceived Limitations: Baseline |
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| CRIS Perceived: Completers End of Part A |
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| CRIS Perceived: Completers End of Part B |
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| CRIS Satisfaction: Baseline |
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| CRIS Satisfaction: Completers End of Part A |
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| CRIS Satisfaction: Completers End of Part B |
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| Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with CRIS: Perceived Limitations data at both time points). | t-test, 2 sided | The sample for this paired t-test was 43 participants. | 0.7363 | Mean Difference (Net) | -0.72 | Standard Deviation | 13.95 | 2-Sided | 95 | -5.01 | 3.67 | Mean difference is the change in scores from Baseline to End of A. | Superiority |
| Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with CRIS: Satisfaction data at both time points). | t-test, 2 sided | The sample for this paired t-test was 43 participants. | 0.2361 | Mean Difference (Net) | -1.49 | Standard Deviation | 8.12 | 2-Sided | 95 | -3.99 | 1.01 | Mean difference is the change in scores from Baseline to End of A. | Superiority |
| Linear regression of scores from CRIS-CAT: Extent of Limitations measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis. | Regression, Linear | The sample for this analysis was 24 participants with TR or TH amputation level who completed data collection for CRIS-CAT at End of Part B. | 0.0932 | Slope | -7.07 | Standard Error of the Mean | 4.02 | 2-Sided | 95 | -15.43 | 1.29 | Effect of EMG-PR (compared to IMU group) | Superiority |
| Linear regression of scores from CRIS-CAT: Perceived Limitations measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis. | Regression, Linear | The sample for this analysis was 24 participants with TR or TH amputation level who completed data collection for CRIS-CAT at End of Part B. | 0.0951 | Mean Difference (Final Values) | -10.5 | Standard Error of the Mean | 6.0 | 2-Sided | 95 | -22.9 | 1.99 | Effect of EMG-PR (compared to IMU group) | Superiority |
| Linear regression of scores from CRIS-CAT: Satisfaction measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis. | Regression, Linear | The sample for this analysis was 24 participants with TR or TH amputation level who completed data collection for CRIS-CAT at End of Part B. | 0.2346 | Slope | -4.91 | Standard Error of the Mean | 4.01 | 2-Sided | 95 | -13.3 | 3.43 | Effect of EMG-PR (compared to IMU group) | Superiority |