Home Study of an Advanced Upper Limb Prosthesis

NCT01551420 | Completed Results FDA Device

• 2 other identifiers: A0771-RA9226-R
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Traumatic Amputation of Arm

Keywords

Amputation; Prosthetic Design; Upper Extremity

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (9)

• Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS) Use Scale

  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

  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)

  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

  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

  Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)

Study Arms (2)

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

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

Device: Advanced upper limb prosthetic EMG-PR controlled

Interventions

Advanced upper limb prosthetic device IMU controlled DEVICE

Advanced upper limb prosthetic IMU controlled

Also known as: DEKA Arm, DARPA Arm IMU controlled

Advanced upper limb prosthetic device IMU controlled

Advanced upper limb prosthetic EMG-PR controlled DEVICE

Advanced upper limb prosthetic EMG-PR controlled

Also known as: DEKA Arm, DARPA Arm EMG-PR controlled

Advanced upper limb prosthetic EMG-PR controlled

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (4)

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

Location

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

New York, New York, 10010, United States

Location

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, 02908, United States

Location

Center for the Intrepid/ Brooke Army Medical Center

San Antonio, Texas, 78234, United States

Location

Related Publications (14)

• 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.

  PMID: 28091278 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.

  PMID: 28487130 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.

  PMID: 28575025 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.

  PMID: 28628623 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.

  PMID: 28914583 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.

  PMID: 28905665 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.

  PMID: 28098513 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

  BACKGROUND

• 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.

  PMID: 28375687 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.

  PMID: 29342217 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.

  PMID: 29741966 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.

  PMID: 29779455 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.

  PMID: 30240420 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.

  PMID: 30335781 RESULT

Results Point of Contact

• Title: Linda Resnik, Research Career Scientist
• Organization: Providence VA Medical Center

Linda.Resnik@va.gov

401-273-7100

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Sequential testing in non-equivalent comparison groups

Study Record Dates

• First Submitted: February 27, 2012
• First Posted: March 12, 2012
• Study Start: April 1, 2012
• Primary Completion: December 19, 2017
• Study Completion: December 31, 2018
• Last Updated: April 30, 2019
• Results First Posted: April 30, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)