Confidence Using a WheelchairNCT01243164
Efficacy of Wheelchair Skills Training on Confidence Using a Manual Wheelchair
A study testing Wheelchair Skills Training Program in people with Confidence Using a Wheelchair, run by University of British Columbia at 2 sites in Canada.
Trial summary
Background and Rationale: Mobility impairment is one of the main correlates of decreased levels of participation in daily and social activities. Mobility disability is often remediable through the use of assistive technology, of which the wheelchair is arguably the most widely used and recognizable form. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Confidence Using a Wheelchair
- What is being tested?
- Wheelchair Skills Training Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesCanada
- Study dates
- Nov 2010to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- able-bodied
- 19 years of age or older
- able to propel a manual wheelchair for at least 10 metres
Who cannot join
- are unable to speak and write in English
- have an upper extremity injury
- use a wheelchair for mobility
- have previously taken part in wheelchair skills training workshops
- have a heart condition that could be worsened by physical activity
- have a physician diagnosis of osteoporosis or osteopenia
- live in residential or long-term care
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Blusson Spinal Cord Centre
Vancouver, British Columbia, V5Z 1M9
GF Strong
Vancouver, British Columbia, V5Z 2G9
About this study
Official title: Efficacy of the Wheelchair Skills Training Program for Improving Confidence With Using a Manual Wheelchair in Younger and Older Able-bodied Adults: A Pilot RCT
Background and Rationale: Mobility impairment is one of the main correlates of decreased levels of participation in daily and social activities. Mobility disability is often remediable through the use of assistive technology, of which the wheelchair is arguably the most widely used and recognizable form. Statistics suggest over 250,000 Canadians use wheelchairs, the majority of whom are older adults.
Mobility impairment often has psychological consequences that may independently restrict functioning and participation. Confidence is one such consequence, and according to Bandura's Social Cognitive Theory, is the belief individuals have in their ability to perform behaviours to achieve desired outcomes. Furthermore, previous findings have accounted for no more than 40% of the variance of factors influencing wheelchair mobility and participation. It is likely that confidence in wheelchair use may account for some of that variance. Recent findings show that approximately 40% of wheelchair users report having low confidence.
Read more
Because confidence is client-specific and modifiable, treatment strategies to address low confidence in using a wheelchair may lead to greater participation among older adults.
Purpose: The overall goal of this research project is to evaluate the efficacy of the Wheelchair Skills Training Program on confidence with using a manual wheelchair in a group of non-wheelchair users.
Objectives:
- Evaluate the efficacy of the Wheelchair Skills Training Program on improving confidence with using a manual wheelchair.
- Evaluate the efficacy of the Wheelchair Skills Training Program on improving wheelchair performance.
- Explore the immediate effect of exposure to wheelchair skills (an outcome measure) on confidence using a manual wheelchair.
Hypotheses:
- Participants who take part in the Wheelchair Skills Training Program will have significant improvements in confidence with using a manual wheelchair compared with those in the control group, as measured by the Wheelchair Use Confidence Scale (WheelCon)
- Participants who receive the Wheelchair Skills Training Program will have significant improvements in wheelchair performance compared to the control group, as measured by the Wheelchair Skills Test (WST).
- All participants will have significant improvements in confidence using a manual wheelchair after exposure to wheelchair skills (during baseline assessment).
Research Method: This study will use 2 concurrent Randomized Controlled Trials to evaluate the efficacy of the Wheelchair Skills Training Program in younger and older adults. Trial 1 and Trial 2 will employ different recruitment approaches for targeting younger versus older adults and different inclusion criteria with regard to age of the participants. Otherwise the research design, protocol and procedures will be the same. Upon completion of data collection, the data will be pooled and stratified by age (younger adult, older adult) for analyses.
Read the detailed description
Background and Rationale:
Mobility impairment is the primary form of reported disability and is also one of the main correlates of decreased levels of participation in daily and social activities, which is an important determinant of quality of life. Mobility disability is often remediable through the use of assistive technology, of which the wheelchair is arguably the most widely used and recognizable form. Statistics suggest over 250,000 Canadians use wheelchairs the majority of whom are older adults.
Sudden health events such as mobility impairment often have psychological consequences that may independently restrict functioning and participation. Confidence is one such consequence, and according to Bandura's Social Cognitive Theory, is the belief individuals have in their ability to perform behaviours to achieve desired outcomes. Furthermore, previous findings have accounted for only 33% and 40% of the variance of factors influencing wheelchair mobility and participation respectively. It is likely that confidence in wheelchair use may account for some of that variance. Confidence in using a wheelchair is an emerging and novel research construct that has the potential for significant impact on healthy and successful aging, and on health services aimed towards the maintenance of functional autonomy among older adults. It is conceptualized as the belief individuals have in their ability to use a wheelchair, and recent findings show that approximately 40% of wheelchair users have low confidence.
Because confidence is client-specific and modifiable, treatment strategies to address low confidence in using a wheelchair may lead to greater mobility and social participation among older adults. Bandura postulates four sources of information to modify confidence: 1) enactive mastery; 2) vicarious learning; 3) verbal persuasion; and 4) physiological/ affective states. Enactive mastery, or experiential learning, is perhaps the most influential source of information. Enactive mastery has been shown to positively alter many forms of confidence including those related to balance, and performance of activities of daily living. In fact, qualitative responses from a community-based study stated that wheelchair users reported increased confidence after completing the Wheelchair Skills Training Program. It is thus plausible that wheelchair skills training may positively influence an older adult's confidence in their ability to use a wheelchair. However, this relationship has not yet been explored.
Purpose: The overall goal of this research project is to evaluate the efficacy of the Wheelchair Skills Training Program on confidence with using a manual wheelchair in younger and older able-bodied adults.
Objectives:
- Evaluate the efficacy of the Wheelchair Skills Training Program on improving confidence with using a manual wheelchair.
- Evaluate the efficacy of the Wheelchair Skills Training Program on improving wheelchair performance.
- Explore the immediate effect of exposure to wheelchair skills on confidence using a manual wheelchair.
- Evaluate the difference in confidence using a manual wheelchair between younger and older adults.
Hypotheses:
- Participants who take part in the Wheelchair Skills Training Program will have significant improvements in confidence with using a manual wheelchair compared with those in the control group.
- Participants who receive the Wheelchair Skills Training Program will have significant improvements in wheelchair performance compared to the control group.
- Confidence with using a manual wheelchair will improve after exposure to wheelchair skills.
- Younger adults will have significantly higher confidence using a manual wheelchair compared to older adults.
Research Method: Concurrent Randomized Controlled Trials in a group of younger (Trial 1) and older (Trial 2) adults.
Trial 1- Participants: Undergraduate and graduate, able-bodied students will be recruited through the University of British Columbia using letters of information, posters, and word-of-mouth.
Sample Size: 20 (10 intervention, 10 control)
Trial 2- Participants: Able-bodied community living, older adults Sample Size: 20 (10 intervention, 10 control)
Trial 1 and Trial 2- Design: Parallel group, randomized controlled trial. Procedures: Informed consent will be obtained from interested participants. Demographic information and information about anxiety and depression, cognitive functioning, and risk propensity will be collected. Participants will then be randomly allocated to either a Wheelchair Skills Training Program (WSTP) or a Control group using a table of random numbers.
All participants will complete baseline and follow-up measures for confidence using a manual wheelchair and wheelchair performance. Participants in the intervention group will complete the WSTP, while participants in the control will just receive one phone call or email from the study investigators.
Statistical Analysis: Demographic information, anxiety and depression, cognitive functioning, and risk propensity will be analyzed using descriptive statistics. The change in confidence with using a manual wheelchair between groups (WSTP and Control) will be analyzed using a 2X3X2 repeated measures ANOVA. The change in confidence with using a manual wheelchair between groups (WSTP and Control) will be analyzed using a 2X2X2 repeated measures ANOVA. All data will be analyzed using SPPS Version 15.0, with alpha equal to 0.05.
- Conditions
- Confidence Using a Wheelchair
- Being tested
- Wheelchair Skills Training Program
- Keywords
- confidence, wheelchair performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wheelchair Skills Training ProgramOther
Also called WSTP
The Wheelchair Skills Training Program will be administered in 2, 1 hour sessions.
| Study group | Role | What they receive |
|---|---|---|
| Wheelchair Skills Training Program | Experimental | A standardized wheelchair skills training program to teach 32 specific wheelchair skills. Receives: Other: Wheelchair Skills Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confidence Using a Wheelchair (WheelCon)
A 63-item questionnaire to assess confidence using a manual wheelchair
Measured: 2 weeks
Secondary outcomes (3)
Wheelchair Skills Test (WST)
A 32-item performance-based wheelchair obstacle course. The WST assessed the ability to perform a standardized set of wheelchair skills and also assess whether the skills were performed safely
Measured: 2 weeks
Hospital Anxiety and Depression Scale (HADS)
HADS is a 14 item questionnaire to asses anxiety and depression.
Measured: 2 weeks
Evaluation of Risk scale (EVAR)
EVAR is a 24 item questionnaire that assesses propensity of risk taking behaviours.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Confidence Using a WheelchairStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William C. Miller, University of British Columbia
- Investigators
- William C Miller, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01243164
- Sponsor's protocol ID
- H10-02385
- Status last verified
- May 2018
- First submitted
- 16 Nov 2010
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Wheelchair Skills Training Program for Improving Confidence With Using a Manual Wheelchair in Younger and Older Able-bodied Adults: A Pilot RCT
- ClinicalTrials.gov ID
- NCT01243164
- Acronym / sponsor ID
- H10-02385
- Conditions
- Confidence Using a Wheelchair
- Keywords
- confidence, wheelchair performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 18 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background and Rationale: Mobility impairment is one of the main correlates of decreased levels of participation in daily and social activities. Mobility disability is often remediable through the use of assistive technology, of which the wheelchair is arguably the most widely used and recognizable form. Statistics suggest over 250,000 Canadians use wheelchairs, the majority of whom are older adults.
Mobility impairment often has psychological consequences that may independently restrict functioning and participation. Confidence is one such consequence, and according to Bandura's Social Cognitive Theory, is the belief individuals have in their ability to perform behaviours to achieve desired outcomes. Furthermore, previous findings have accounted for no more than 40% of the variance of factors influencing wheelchair mobility and participation. It is likely that confidence in wheelchair use may account for some of that variance. Recent findings show that approximately 40% of wheelchair users report having low confidence.
Because confidence is client-specific and modifiable, treatment strategies to address low confidence in using a wheelchair may lead to greater participation among older adults.
Purpose: The overall goal of this research project is to evaluate the efficacy of the Wheelchair Skills Training Program on confidence with using a manual wheelchair in a group of non-wheelchair users.
Objectives:
- Evaluate the efficacy of the Wheelchair Skills Training Program on improving confidence with using a manual wheelchair.
- Evaluate the efficacy of the Wheelchair Skills Training Program on improving wheelchair performance.
- Explore the immediate effect of exposure to wheelchair skills (an outcome measure) on confidence using a manual wheelchair.
Hypotheses:
- Participants who take part in the Wheelchair Skills Training Program will have significant improvements in confidence with using a manual wheelchair compared with those in the control group, as measured by the Wheelchair Use Confidence Scale (WheelCon)
- Participants who receive the Wheelchair Skills Training Program will have significant improvements in wheelchair performance compared to the control group, as measured by the Wheelchair Skills Test (WST).
- All participants will have significant improvements in confidence using a manual wheelchair after exposure to wheelchair skills (during baseline assessment).
Research Method: This study will use 2 concurrent Randomized Controlled Trials to evaluate the efficacy of the Wheelchair Skills Training Program in younger and older adults. Trial 1 and Trial 2 will employ different recruitment approaches for targeting younger versus older adults and different inclusion criteria with regard to age of the participants. Otherwise the research design, protocol and procedures will be the same. Upon completion of data collection, the data will be pooled and stratified by age (younger adult, older adult) for analyses.
Detailed description
Background and Rationale:
Mobility impairment is the primary form of reported disability and is also one of the main correlates of decreased levels of participation in daily and social activities, which is an important determinant of quality of life. Mobility disability is often remediable through the use of assistive technology, of which the wheelchair is arguably the most widely used and recognizable form. Statistics suggest over 250,000 Canadians use wheelchairs the majority of whom are older adults.
Sudden health events such as mobility impairment often have psychological consequences that may independently restrict functioning and participation. Confidence is one such consequence, and according to Bandura's Social Cognitive Theory, is the belief individuals have in their ability to perform behaviours to achieve desired outcomes. Furthermore, previous findings have accounted for only 33% and 40% of the variance of factors influencing wheelchair mobility and participation respectively. It is likely that confidence in wheelchair use may account for some of that variance. Confidence in using a wheelchair is an emerging and novel research construct that has the potential for significant impact on healthy and successful aging, and on health services aimed towards the maintenance of functional autonomy among older adults. It is conceptualized as the belief individuals have in their ability to use a wheelchair, and recent findings show that approximately 40% of wheelchair users have low confidence.
Because confidence is client-specific and modifiable, treatment strategies to address low confidence in using a wheelchair may lead to greater mobility and social participation among older adults. Bandura postulates four sources of information to modify confidence: 1) enactive mastery; 2) vicarious learning; 3) verbal persuasion; and 4) physiological/ affective states. Enactive mastery, or experiential learning, is perhaps the most influential source of information. Enactive mastery has been shown to positively alter many forms of confidence including those related to balance, and performance of activities of daily living. In fact, qualitative responses from a community-based study stated that wheelchair users reported increased confidence after completing the Wheelchair Skills Training Program. It is thus plausible that wheelchair skills training may positively influence an older adult's confidence in their ability to use a wheelchair. However, this relationship has not yet been explored.
Purpose: The overall goal of this research project is to evaluate the efficacy of the Wheelchair Skills Training Program on confidence with using a manual wheelchair in younger and older able-bodied adults.
Objectives:
- Evaluate the efficacy of the Wheelchair Skills Training Program on improving confidence with using a manual wheelchair.
- Evaluate the efficacy of the Wheelchair Skills Training Program on improving wheelchair performance.
- Explore the immediate effect of exposure to wheelchair skills on confidence using a manual wheelchair.
- Evaluate the difference in confidence using a manual wheelchair between younger and older adults.
Hypotheses:
- Participants who take part in the Wheelchair Skills Training Program will have significant improvements in confidence with using a manual wheelchair compared with those in the control group.
- Participants who receive the Wheelchair Skills Training Program will have significant improvements in wheelchair performance compared to the control group.
- Confidence with using a manual wheelchair will improve after exposure to wheelchair skills.
- Younger adults will have significantly higher confidence using a manual wheelchair compared to older adults.
Research Method: Concurrent Randomized Controlled Trials in a group of younger (Trial 1) and older (Trial 2) adults.
Trial 1- Participants: Undergraduate and graduate, able-bodied students will be recruited through the University of British Columbia using letters of information, posters, and word-of-mouth.
Sample Size: 20 (10 intervention, 10 control)
Trial 2- Participants: Able-bodied community living, older adults Sample Size: 20 (10 intervention, 10 control)
Trial 1 and Trial 2- Design: Parallel group, randomized controlled trial. Procedures: Informed consent will be obtained from interested participants. Demographic information and information about anxiety and depression, cognitive functioning, and risk propensity will be collected. Participants will then be randomly allocated to either a Wheelchair Skills Training Program (WSTP) or a Control group using a table of random numbers.
All participants will complete baseline and follow-up measures for confidence using a manual wheelchair and wheelchair performance. Participants in the intervention group will complete the WSTP, while participants in the control will just receive one phone call or email from the study investigators.
Statistical Analysis: Demographic information, anxiety and depression, cognitive functioning, and risk propensity will be analyzed using descriptive statistics. The change in confidence with using a manual wheelchair between groups (WSTP and Control) will be analyzed using a 2X3X2 repeated measures ANOVA. The change in confidence with using a manual wheelchair between groups (WSTP and Control) will be analyzed using a 2X2X2 repeated measures ANOVA. All data will be analyzed using SPPS Version 15.0, with alpha equal to 0.05.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wheelchair Skills Training Program | Experimental | Other: Wheelchair Skills Training ProgramA standardized wheelchair skills training program to teach 32 specific wheelchair skills. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- able-bodied
- 19 years of age or older
- able to propel a manual wheelchair for at least 10 metres
Key exclusion criteria (7 listed)
- are unable to speak and write in English
- have an upper extremity injury
- use a wheelchair for mobility
- have previously taken part in wheelchair skills training workshops
- have a heart condition that could be worsened by physical activity
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 |
|---|---|---|
| Wheelchair Skills Training ProgramAlso: WSTPThe Wheelchair Skills Training Program will be administered in 2, 1 hour sessions. | Other | Wheelchair Skills Training Program |
Primary outcome
Confidence Using a Wheelchair (WheelCon)
Time frame: 2 weeks
A 63-item questionnaire to assess confidence using a manual wheelchair
3 secondary outcomes
Wheelchair Skills Test (WST)
Time frame: 2 weeks
Hospital Anxiety and Depression Scale (HADS)
Time frame: 2 weeks
Evaluation of Risk scale (EVAR)
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- Related InfoLink provided by the sponsor.
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.
William C Miller, PhD principal investigator
University of British Columbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wheelchair Skills Training Program in people with Confidence Using a Wheelchair, run by University of British Columbia at 2 sites in Canada.
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 3 inclusion and 7 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 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Confidence Using a Wheelchair (WheelCon) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2018.