Powered Seating Function Usage Among Veterans - Compliance and Coaching
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|ClinicalTrials.gov Identifier: NCT00839098|
Recruitment Status : Completed
First Posted : February 9, 2009
Results First Posted : February 4, 2016
Last Update Posted : February 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Use of Power Wheelchairs and Power Seat Functions||Other: Instruction Group: Power seat function usage instruction- verbal and written instruction Other: Instruction and Virtual Coach Group: Power seat function usage instruction- verbal, written, and virtual coach||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Powered Seating Function Usage Among Veterans - Compliance and Coaching|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||November 2014|
No Intervention: Control Group
Experimental: Instruction Group
Other: Instruction Group: Power seat function usage instruction- verbal and written instruction
Subjects assigned to the Intervention Group will be assigned to an Intervention Group Clinician. The Intervention Group Clinicians will provide the same training as the Control Group Clinicians, with the addition of discussing the Veteran's activity and seating function usage data, reviewing and providing a study pamphlet and compact disk as a reference guide on use of power seat functions.
Experimental: Instruction and Virtual Coach Group
Instruction and Virtual Coach Group
Other: Instruction and Virtual Coach Group: Power seat function usage instruction- verbal, written, and virtual coach
Subjects assigned to the Instruction & Virtual Coach Group will be assigned to an Intervention Group Clinician and will receive the same training and instructional materials as the Instruction Group. Subjects 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. As the Virtual Coach is a dynamic intelligent system, it will adjust its coaching to the needs of the individual. For example, if the person is compliant, the Virtual Coach will give positive feedback and then gradually transition to operating quietly in the background. If a person is not fully compliant, it will alter feedback modes (e.g., verbal cues, auditory tones, visual cues) and timing to attempt to increase compliance.
- Compliance Rate [ Time Frame: 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.
- Frequency of Power Seat Function Usage [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
- Questionnaire Responses: Tool for Assessing Wheelchair Discomfort (TAWC) [ Time Frame: Every 2 weeks for 8 weeks following acquisition of wheelchair ]General Discomfort Assessment (GD) and Discomfort Intensity Rating (DI) are two sub-scales of TAWC. Higher scores indicate greater discomfort. GD consists of 8 discomfort statements and 5 comfort statements. The statements are rated on a seven point Likert scale, from strongly disagree to strongly agree of points from 1-7 (total score: 13-91). DI includes seven body areas (back, neck, buttocks, legs, arms, feet, and hands) and overall discomfort level, rated for a degree of discomfort intensity on a scale of 0 (no discomfort) to 10 (severe discomfort). Space is also included for the user to list additional body areas. DI scores may range from 0 to more than 80, depending on whether the participant reported additional areas of discomfort. Although GD and DI were measured daily, the data were average for each two-week period. The average GD and DI of the difference between the baseline and week 7-8 (last 2 weeks) were shown here.
- Questionnaire Responses: Psychological Impacts of Assistive Devices Scale [ Time Frame: At the end of every two weeks ]This tool is to measure perceived psychological impact of using an assistive device. It consists of three subscales, Competence (12 items), Adaptability (6 items), and Self-esteem (8 items). Each item is scored on a likert scale from -3 (decreases) to + 3 (increases). The total score is the sum of all 26 items, ranging from -78 to 78. A higher positive score indicates more positive impact. A negative score indicates negative impact. The differences between the measurements taken at the end of 2nd week (end of baseline) and the end of 8th week (end of intervention period) are reported here to show the intervention effect.
- Questionnaire Responses: Independence in Community [ Time Frame: At the end of 2nd (end of baseline) week and 8th week (end of intervention period) following acquisition of wheelchair ]This outcome was measured in three aspects: Physical Independence, Cognitive Independence, and Mobility, using the three of the subscales of Craig Handicap Assessment and Reporting Technique Scale. The scores of each subscale has to be calculated with specific formula and weight based on the manual. The range of each subscale score are: Physical Independence: 28-100; Cognitive Independence: 15-100; and Mobility: 16-100. A higher score indicates greater independence. The analyzed results of the difference between the measurements at the end of 2nd week and 8th week were shown here.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00839098
|United States, Pennsylvania|
|VA Pittsburgh Health Care System|
|Pittsburgh, Pennsylvania, United States, 15240|
|Principal Investigator:||Rory A. Cooper, PhD||Director, Center of Excellence for Wheelchairs and Related Technology|