跳至主要内容
临床试验/NCT00839098
NCT00839098已完成不适用

Powered Seating Function Usage Among Veterans - Compliance and Coaching

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2011年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
1
主要终点
Frequency of Power Seat Function Usage

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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).

研究组 & 干预措施

Control Group

No Intervention

Control Group

Instruction Group

Experimental

Instruction Group

干预措施: Instruction Group: Power seat function usage instruction- verbal and written instruction (Other)

Instruction and Virtual Coach Group

Experimental

Instruction and Virtual Coach Group

干预措施: Instruction and Virtual Coach Group: Power seat function usage instruction- verbal, written, and virtual coach (Other)

结局指标

主要结局

Frequency of Power Seat Function Usage

时间窗: Every 2 weeks for 8 weeks following acquisition of wheelchair

Frequency of power seat function usage was measured by the number of times of changing tilt and recline angles averaged by the duration that the participant occupied the wheelchair per day. The results of the difference between the baseline and week 7-8 (last 2 weeks) were shown here.

Power Wheelchair Usage

时间窗: Every 2 weeks for 8 weeks following acquisition of wheelchair

Power wheelchair usage was measured by the sum of distances that the power wheelchair traveled (km) divided by the duration of the wheelchair being occupied a day (hr). The result of the difference between the baseline and week 7-8 (last 2 weeks) was shown here.

Wheelchair Occupancy

时间窗: Every 2 weeks for 8 weeks following acquisition of wheelchair

Wheelchair occupancy was measured by the sum of duration that the seat of the wheelchair was occupied. The results of the difference between the baseline and week 7-8 (last 2 weeks) were shown here.

Compliance Rate

时间窗: Every 2 weeks for 8 weeks following acquisition of wheelchair

Compliance rate is a measure of compliance with the recommendation of using powered seating functions (moderate or maximum range of tilt, at least once every hour, for 2 minutes). The participant had to follow the recommended position, duration, and frequency to be considered as compliant and performed successful repositioning exercise. The compliance rate of a participant was the number of successful repositioning exercise divided by the sum of the number of successful repositioning exercise and missed repositioning exercise. The result of the difference between the baseline and week 7-8 (last 2 weeks) was shown here.

次要结局

  • Questionnaire Responses: Tool for Assessing Wheelchair Discomfort (TAWC)(Every 2 weeks for 8 weeks following acquisition of wheelchair)
  • Questionnaire Responses: Psychological Impacts of Assistive Devices Scale(At the end of every two weeks)
  • Questionnaire Responses: Independence in Community(At the end of 2nd (end of baseline) week and 8th week (end of intervention period) following acquisition of wheelchair)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验