Clinical trial NCT00839098: Powered Seating Function Usage Among Veterans - Compliance and Coaching
Official title: Powered Seating Function Usage Among Veterans - Compliance and Coaching
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Use of Power Wheelchairs and Power Seat Functions
Keywords: power wheelchairs
assistive technology
rehabilitation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-02-09
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this randomized control study is to evaluate the use of electric powered wheelchairs and powered seating function patterns of Veterans to determine how usage patterns relate to activity, participation, and seating discomfort. In addition, it will be determined if a training program or a training program with a virtual coach will improve compliance of clinical practice guidelines for pressure relief, upper limb preservation, and discomfort management. The virtual coach is a portable, programmable intelligent reminder designed to enhance a person's use of their power wheelchair and power seat functions.

Detailed description: This is a randomized control trial evaluating power seat function usage among 3 groups: 1) standard of care- verbal instruction 2) verbal and written instruction and 3) same as #2 with addition of virtual coach. This study will be conducted in two phases. Phase I data will be collected for 8 weeks, during the time period that the subject is awaiting for delivery of their personal electric powered wheelchair (EPW) with powered seat functions. Phase II data will be collected for a total of 4 weeks, after the subject receives their personal wheelchair. During Phase I, Visit I, subjects will be fitted for a study EPW with powered seat functions. All subjects will be provided with the "standard of care" training on driving of the wheelchair and usage of the power seating functions. Subjects will be instructed to go about their daily activities as they normally would, while the instrumented wheelchair will track their usage of the wheelchair and seating habits. Phase I, Visit II-IV, subjects will be randomized into one of three study groups: Control Group; Instruction Group; and Instruction \& Virtual Coach Group. Subjects assigned to the Control Group will receive 'standard of care.' Subjects assigned to the Intervention Group will receive the "standard of care" and additional written instructional materials and feedback regarding activity and wheelchair usage. Subjects assigned to the Instruction \& Virtual Coach Group will receive the same training and instructional materials as the Intervention Group. This group will also be instructed in use of the virtual coach system, which will be active during the in-home usage periods to provide personalized feedback. Phase II will involve mounting a wheelchair and seat function usage datalogger to the subject's personal wheelchair over a period of 4 weeks.

Eligibility criteria: Inclusion Criteria:

* Subjects must be 18 years of age or older.
* A power wheelchair with power seat functions must be recommended as medically necessary by a qualified clinician with ATP credential or board certified in physical medicine and rehabilitation from the VAPHS Wheelchair and Seating Clinic or the Center for Assistive Technology.
* Subjects must be able to be properly fitted with one of the study EPWs; 18" or 20" seat widths will be available. Cushions and backrests will be made available to meet subject's clinical needs.
* Subject's home must be accessible to accommodate use of a power w/c.
* Subject must be determined to be fully capable of examining his/her sitting surface daily for redness or pressure ulcers or if not that another individual can be designated as able and willing to-do this.

Exclusion Criteria:

* Subjects who have active pelvic, gluteal or thigh wounds or who have had a pressure ulcer in these regions within the past 30 days. (They may be worsened by prolonged sitting).
* Subjects who report more than 5 days of hospitalization in the previous month. (They may not spend enough time using an EPW with powered seating functions).

Primary outcomes:
measure: Compliance Rate
timeFrame: Every 2 weeks for 8 weeks following acquisition of wheelchair
measure: Frequency of Power Seat Function Usage
timeFrame: Every 2 weeks for 8 weeks following acquisition of wheelchair
measure: Power Wheelchair Usage
timeFrame: Every 2 weeks for 8 weeks following acquisition of wheelchair
measure: Wheelchair Occupancy
timeFrame: Every 2 weeks for 8 weeks following acquisition of wheelchair
Secondary outcomes:
measure: Questionnaire Responses: Tool for Assessing Wheelchair Discomfort (TAWC)
timeFrame: Every 2 weeks for 8 weeks following acquisition of wheelchair
measure: Questionnaire Responses: Psychological Impacts of Assistive Devices Scale
timeFrame: At the end of every two weeks
measure: Questionnaire Responses: Independence in Community
timeFrame: At the end of 2nd (end of baseline) week and 8th week (end of intervention period) following acquisition of wheelchair
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: VA Pittsburgh Health Care System
state: Pennsylvania
Study officials:
affiliation: Director, Center of Excellence for Wheelchairs and Related Technology
name: Rory A. Cooper, PhD
role: PRINCIPAL_INVESTIGATOR
References: