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Home Study of an Advanced Upper Limb Prosthesis

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01551420
First received: February 27, 2012
Last updated: October 16, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Traumatic Amputation of Arm
Device: Advanced upper limb prosthetic device

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Home Study of an Advanced Upper Limb Prosthesis

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Change in Quality of Life (QOL) scale [ Time Frame: baseline and after 13 weeks of home use ] [ Designated as safety issue: No ]
    The QOL consists of 16 questions that assess satisfaction with independent living and self-care activities


Secondary Outcome Measures:
  • Home Use Appropriateness [ Time Frame: Up to 6 Weeks of in lab use ] [ Designated as safety issue: No ]
    Performance based criteria (developed for this study) relating to skillfulness of prosthetic use, independence in daily device maintenance and storage, and safety awareness.

  • Extent of Prosthetic Use [ Time Frame: 2 weeks prior to in-laboratory training, and daily throughout the home usage portion of the study ] [ Designated as safety issue: No ]
    Daily logs (developed for this study) detailing usage of current prostheses and the advanced prosthetic device.

  • Trinity Amputations and Prosthetics Experience Scale (TAPES) [ Time Frame: Baseline, Visit 14, Up to 6 Weeks of in lab use, Bi-Weekly (throughout the home usage portion of the study), After 13 weeks of home use ] [ Designated as safety issue: No ]
    The TAPES Satisfaction scale is a 10 item scale which includes questions about extent of satisfaction regarding functional characteristics of the artificial limb: reliability, comfort, fit, and overall satisfaction, contentment with cosmetic characteristics of the device.

  • Activities Measure for Upper limb amputees (AM-ULA) [ Time Frame: Baseline, Visit 14, Up to 6 Weeks of in lab use, Bi-Weekly (throughout the home usage portion of the study), After 13 weeks of home use ] [ Designated as safety issue: No ]
    The AM-ULA is a new 18 item observational measure that assesses key elements of 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.

  • SF-36 V [ Time Frame: Baseline, Visit 14, Up to 6 Weeks of in lab use, Bi-Weekly (throughout the home usage portion of the study), After 13 weeks of home use ] [ Designated as safety issue: No ]
    Four scales of the SF-36V will be used to assess quality of life: Role Physical, Role Emotional, Social Functioning, and Physical Functioning

  • Neuropsychological Testing Battery [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The battery is comprised of following tests: Color-Word Interference and Verbal Fluency from the Delis-Kaplan Executive Function System (D-KEFS), Judgment of Line Orientation (JLO), Digit Span and Letter-Number Sequencing subtests from the Wechsler Adult Intelligence Scale - IV (WAIS-IV), oral versions of the Trail Making Test parts A & B, Symbol-Digit Modalities Test, Shape Learning and Shape Recall items from the Screening Module of the Neuropsychological Assessment Battery (NAB), and several components of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).

  • Wong-Baker FACES Pain Rating Scale (FACES) [ Time Frame: Baseline, Visit 14, Up to 6 Weeks of in lab use, Bi-Weekly (throughout the home usage portion of the study), After 13 weeks of home use ] [ Designated as safety issue: No ]
    The FACES is a 6-point pain scale that utilizes faces to indicate the intensity of pain. The subject is asked to choose the face that best describes how he/she is feeling.

  • Jebsen-Taylor Hand Function Test (JTHFT) [ Time Frame: Baseline, Visit 14, Up to 6 Weeks of in lab use, Monthly (throughout the home usage portion of the study) ] [ Designated as safety issue: No ]
    This seven-part test evaluates the time needed to perform 7 hand-related tasks including: 1) printing a 24-letter, third-grade reading difficulty sentence, 2) turning over 7.6 x 12.7 cm (3x5") cards in simulated page turning, 3) picking up small common objects including pennies, paper clips, bottle caps and placing them in a container, 4) stacking checkers, 5) simulated feeding, 6) moving large empty cans and 7) moving large 1 lb. cans.

  • University of New Brunswick Test of Prosthetic Function (UNB) [ Time Frame: Baseline, Visit 14, Up to 6 Weeks of in lab use, Monthly (throughout the home usage portion of the study) ] [ Designated as safety issue: No ]
    This test will be used for unilateral amputees only. We will use a subtest which includes the following activities: wrapping a parcel, sewing a button on cloth, cutting meat, drying dishes, sweeping floor, and using a dustpan and brush.

  • Adapted Rivermead Extended Activities Index (REAI) [ Time Frame: Baseline, Visit 14, Up to 6 Weeks of in lab use, Monthly (throughout the home usage portion of the study) ] [ Designated as safety issue: No ]
    We will utilize selected items from the REAI, a performance based instrumental activity measure that is scored on a three-point scale: 1, dependent; 2, independent but requires verbal supervision; and 3, independent. We will also add a timed element to the testing procedures.

  • Upper Extremity Functional Scale (UEFS) from the Orthotics and Prosthetics Users Survey (OPUS) [ Time Frame: Visit 14, Up to 6 Weeks of in lab use, Bi-Weekly (throughout the home usage portion of the study), After 13 weeks of home use ] [ Designated as safety issue: No ]
    The UEFS is a self-report measure developed for use with upper limb adult amputees. It includes 23 activities: self-care, instrumental, and daily living tasks using a 5-point scale from 0- cannot perform the activity to 4-very difficult.

  • The Patient Specific Functional Scale (PSFS) [ Time Frame: Baseline, Visit 14, Up to 6 Weeks of in lab use, Bi-Weekly (throughout the home usage portion of the study), After 13 weeks of home use ] [ Designated as safety issue: No ]
    The PSFS is a patient-specific outcome measure to assess functional status. Subjects identify up to five activities that they have difficulty performing due to their condition and then rate the amount of limitation they have in performing on a scale of 0 to 10 with 0 being unable to perform the activity and 10 being able to perform the activity with no problem.

  • The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT) [ Time Frame: Baseline, Visit 14, Up to 6 Weeks of in lab use, Bi-Weekly (throughout the home usage portion of the study), After 13 weeks of home use ] [ Designated as safety issue: No ]
    The CRIS measures community reintegration of veterans, using the construction of participation. It consists of three scales which assess three different dimensions of community integration, extent and frequency, perceived limitations, and satisfaction.


Estimated Enrollment: 75
Study Start Date: April 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
Subjects with upper limb amputation
Device: Advanced upper limb prosthetic device
There are three versions of the advanced upper limb prosthetic device: shoulder configuration (SC, also known as shoulder disarticulation (SD)); humeral configuration (HC also known as transhumeral (TH)) and radial configuration (RC also known as transradial (TR)).
Other Name: DEKA Arm, DARPA Arm

Detailed Description:

The specific objectives of this study are to:

  1. 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.
  2. compare the extent of use of the existing prosthesis to that of the advanced upper limb prosthetic device.
  3. quantify the impact of home use of the DEKA Arm on device satisfaction, performance of functional activities, and the user's quality of life.
  4. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Males and females with single or bilateral upper limb amputation

Criteria

Inclusion Criteria:

Inclusion Criteria (Parts A and B):

  • 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.

Inclusion Criteria Part B only:

  • Completion of all Part A study activities.
  • Meets all criteria for Preliminary Determination of Appropriateness for Unsupervised, Home Device Use.

Exclusion Criteria:

Exclusion Criteria (Parts A and B):

  • Amputees with elbow disarticulation, wrist disarticulation and partial hand amputations 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.
  • We 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01551420

Contacts
Contact: Kate J Barnabe, MHA (401) 273-7100 ext 6272 Kate.Barnabe@va.gov

Locations
United States, Florida
James A. Haley Veterans' Hospital, Tampa, FL Recruiting
Tampa, Florida, United States, 33612
Contact: Deborah Gavin-Dreschnack, PhD    813-588-3946    deborah.Gavin-Dreschnack@va.gov   
United States, New York
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY Recruiting
New York, New York, United States, 10010
Contact: MaryAnne Garbarini, MPT    212-951-3339    maryanne.garbarini@va.gov   
United States, Rhode Island
Providence VA Medical Center, Providence, RI Recruiting
Providence, Rhode Island, United States, 02908
Contact: Kate J Barnabe, MHA    401-273-7100 ext 6272    Kate.Barnabe@va.gov   
Principal Investigator: Linda J Resnik, PhD MS         
United States, Texas
Center for the Intrepid/ Brooke Army Medical Center Recruiting
San Antonio, Texas, United States, 78234
Contact: Sandra Jarzombek    210-916-8295    Sandi.Jarzombek@us.army.mil   
Sponsors and Collaborators
Investigators
Principal Investigator: Linda J Resnik, PhD MS Providence VA Medical Center, Providence, RI
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01551420     History of Changes
Other Study ID Numbers: A9226-R
Study First Received: February 27, 2012
Last Updated: October 16, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Amputation
Prosthetic Design
Upper Extremity

Additional relevant MeSH terms:
Amputation, Traumatic
Wounds and Injuries

ClinicalTrials.gov processed this record on November 23, 2014