Use of Power Wheelchairs and Power Seat FunctionsNCT00839098

Powered Seating Function Usage Among Veterans - Compliance and Coaching

A study testing Instruction Group: Power seat function usage instruction- verbal and written instruction and Instruction and Virtual Coach Group: Power seat function usage instruction- verbal, written, and virtual coach in people with Use of Power Wheelchairs and Power Seat Functions, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Use of Power Wheelchairs and Power Seat Functions
What is being tested?: Instruction Group: Power seat function usage instruction- verbal and written instruction and Instruction and Virtual Coach Group: Power seat function usage instruction- verbal, written, and virtual coach
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteUnited States
Study dates: Nov 2011to Nov 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Pittsburgh Health Care System
Pittsburgh, Pennsylvania, 15240

Other trials in United States

About this study

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.

Read the 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.

Conditions: Use of Power Wheelchairs and Power Seat Functions
Being tested: Instruction Group: Power seat function usage instruction- verbal and written instruction, Instruction and Virtual Coach Group: Power seat function usage instruction- verbal, written, and virtual coach
Keywords: power wheelchairs, assistive technology, rehabilitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Instruction Group: Power seat function usage instruction- verbal and written instructionOther
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.
Instruction and Virtual Coach Group: Power seat function usage instruction- verbal, written, and virtual coachOther
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.

Study groups in NCT00839098
Study group	Role	What they receive
Control Group	No intervention	Control Group
Instruction Group	Experimental	Instruction Group Receives: Other: Instruction Group: Power seat function usage instruction- verbal and written instruction
Instruction and Virtual Coach Group	Experimental	Instruction and Virtual Coach Group Receives: Other: Instruction and Virtual Coach Group: Power seat function usage instruction- verbal, written, and virtual coach

What is being measured

The primary outcome is the main question the study is designed to answer.

Compliance Rate
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.
Measured: Every 2 weeks for 8 weeks following acquisition of wheelchair
Frequency of Power Seat Function Usage
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.
Measured: Every 2 weeks for 8 weeks following acquisition of wheelchair
Power Wheelchair Usage
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.
Measured: Every 2 weeks for 8 weeks following acquisition of wheelchair
Wheelchair Occupancy
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.
Measured: Every 2 weeks for 8 weeks following acquisition of wheelchair

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2011Nov 2014

First posted9 Feb 2009 (estimated)
Study startNov 2011
Primary completionDec 2013
Study completionNov 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Use of Power Wheelchairs and Power Seat FunctionsStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00839098
Sponsor's protocol ID: B6591-R
Status last verified: Jan 2016
First submitted: 6 Feb 2009
Last updated: 4 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Powered Seating Function Usage Among Veterans - Compliance and Coaching
ClinicalTrials.gov ID: NCT00839098
Acronym / sponsor ID: B6591-R
Conditions: Use of Power Wheelchairs and Power Seat Functions
Keywords: power wheelchairs, assistive technology, rehabilitation
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: Nov 2011
Primary completion: Dec 2013 (actual)
Study completion: Nov 2014 (actual)
First posted: 9 Feb 2009 (estimated)
Results: Posted 4 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Control Group	No intervention	–Control Group
Instruction Group	Experimental	Other: Instruction Group: Power seat function usage instruction- verbal and written instructionInstruction Group
Instruction and Virtual Coach Group	Experimental	Other: Instruction and Virtual Coach Group: Power seat function usage instruction- verbal, written, and virtual coachInstruction and Virtual Coach Group

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (2 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Instruction Group: Power seat function usage instruction- verbal and written instructionSubjects 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.	Other	Instruction Group
Instruction and Virtual Coach Group: Power seat function usage instruction- verbal, written, and virtual coachSubjects 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.	Other	Instruction and Virtual Coach Group

Primary outcome

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.

3 secondary outcomes

Questionnaire Responses: Tool for Assessing Wheelchair Discomfort (TAWC)
Time frame: Every 2 weeks for 8 weeks following acquisition of wheelchair
Questionnaire Responses: Psychological Impacts of Assistive Devices Scale
Time frame: At the end of every two weeks
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

Results and safety

Results posted to the registry on 4 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Group	3	1
Instruction Group	12	11
Instruction and Virtual Coach Group	13	6

Primary outcome: Compliance Rate

Time frame: Every 2 weeks for 8 weeks following acquisition of wheelchair. Mean (Standard Deviation). Unit: Percentage of participants' compliance

Measure	Arm 1: Control Group n = 0	Arm 2: Instruction Group n = 10	Arm 3: Instruction + VSC Group n = 6
Value	–	8.9 (15.9)	39.7 (23.5)

Arm 2: Instruction Group vs Arm 3: Instruction + VSC Group: p = 0.27, Wilcoxon (Mann-Whitney)

Population analysed: Only the data of the participants who completed the study protocol and use the wheelchair were included in the data analysis.

Primary outcome: Frequency of Power Seat Function Usage

Time frame: Every 2 weeks for 8 weeks following acquisition of wheelchair. Mean (Standard Deviation). Unit: times/hour

Measure	Arm 1: Control Group n = 0	Arm 2: Instruction Group n = 10	Arm 3: Instruction + VSC Group n = 6
Freq of mod & max tilt (times/hr): Difference	–	.51 (2.52)	0.03 (2.51)
Freq of mod & max recline (times/hr): Difference	–	-0.43 (1.36)	0.09 (0.15)

Arm 2: Instruction Group vs Arm 3: Instruction + VSC Group: p >0.05, Wilcoxon (Mann-Whitney)

Population analysed: Only the data of the participants who completed the study protocol and use the wheelchair were included in the data analysis.

Primary outcome: Power Wheelchair Usage

Time frame: Every 2 weeks for 8 weeks following acquisition of wheelchair. Mean (Standard Deviation). Unit: km/hour

Measure	Arm 1: Control Group n = 0	Arm 2: Instruction Group n = 10	Arm 3: Instruction + VSC Group n = 6
Value	–	0.17 (0.45)	-0.04 (0.08)

Arm 2: Instruction Group vs Arm 3: Instruction + VSC Group: p >0.05, Wilcoxon (Mann-Whitney)

Population analysed: Only the data of the participants who completed the study protocol and use the wheelchair were included in the data analysis.

Primary outcome: Wheelchair Occupancy

Time frame: Every 2 weeks for 8 weeks following acquisition of wheelchair. Mean (Standard Deviation). Unit: hours

Measure	Arm 1: Control Group n = 0	Arm 2: Instruction Group n = 10	Arm 3: Instruction + VSC Group n = 6
Value	–	-.07 (1.9)	-0.4 (1.8)

Arm 2: Instruction Group vs Arm 3: Instruction + VSC Group: p >0.05, Wilcoxon (Mann-Whitney)

Population analysed: Only the data of the participants who completed the study protocol and use the wheelchair were included in the data analysis.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Group	0 of 3 (0%)	0 of 3 (0%)	Not reported
Instruction Group	0 of 12 (0%)	0 of 12 (0%)	Not reported
Instruction and Virtual Coach Group	0 of 13 (0%)	0 of 13 (0%)	Not reported

Limitations and caveats (from the sponsor): It was difficult to recruit power wheelchair users to participate in the study. Participants withdrew from the study because the study wheelchair could not meet their needs, or they could not use the Virtual Seating Coach independently.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rory A. Cooper, PhD principal investigator

Director, Center of Excellence for Wheelchairs and Related Technology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compliance Rate (time frame: Every 2 weeks for 8 weeks following acquisition of wheelchair). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00839098.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2016.