Wheelchair User's Voice- A Longitudinal Study About the Impact of the WHO-8 Steps for Wheelchair Provision in El Salvador
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Momentum Wheels for Humanity
- Enrollment
- 264
- Locations
- 13
- Primary Endpoint
- Massachusetts Institute of Technology (MIT)-Wheelchair-related Health Questionnaire
Study Overview
Brief Summary
The objective of this study was to test the hypotheses that wheelchair-related health, wheelchair skills, wheelchair use, poverty probability, and quality of life would improve; and that the number of wheelchair repairs required, adverse events, caregiver burden and the level of assistance provided would decrease after the delivery of manual wheelchairs following the World Health Organization (WHO) 8-step service-delivery process.
This was a longitudinal, within-subject study design including 247 manual wheelchair users in El Salvador. The intervention consisted of the WHO 8-step process as well as maintenance reminders. Outcome assessments on wheelchair-related health, wheelchair skills, wheelchair repairs required, adverse events, caregiver burden and the level of assistance, poverty probability, and quality of life were performed via structured interviews at the initial assessment, at wheelchair delivery, and at 3- and 6-month follow-up. Wheelchair use was measured with dataloggers at assessment, delivery and 3-month follow-up.
Detailed Description
Ethics approval was granted from the National Committee on Research Ethics for Health in El Salvador (CNEIS/2018/043) and the Institutional Review Board at the University of Pittsburgh (number PRO18010578). Written informed consent was obtained from all participants before implementing study procedures.
All procedures of the study were conducted at 11 different rehabilitation centers, that served as wheelchair service delivery centers, in El Salvador.
A consecutive sampling method was used to select participants using the waitlists at the 11 rehabilitation centers. The investigators recruited wheelchair users and their caregivers.
Following the initial assessment, all participants were placed on a waiting list until wheelchairs and services were available. All study participants were provided with a new wheelchair (standard, active, or all-terrain model), a wheelchair cushion, and wheelchair services, delivered by trained wheelchair service providers, according to the WHO 8-step wheelchair service delivery process including assessment, fitting, and a 30-minute individual or group training on 7 wheelchair skills, device care, and pressure injury prevention techniques.
In addition, all wheelchairs were provided with a basic contour cushion made of polyurethane foam. However, whenever a risk of pressure injury was identified for a study participant, wheelchair providers fabricated a pressure-relief cushion based on the WHO basic wheelchair service guidelines.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Inclusion criteria for wheelchair users were being a person with a mobility limitation requiring a wheelchair as a primary means of personal mobility, waiting to receive a new wheelchair from any of the participating wheelchair service delivery centers, 18-years of age or older, had the cognitive and verbal abilities required to respond to the study questions or a proxy who could respond on his or her behalf, and had access to a cellphone.
- •Inclusion criteria for caregivers were being a person assisting the wheelchair user with activities of daily living (ADL), 18-years of age or older, being the primary caregiver and willing to participate in the study.
Exclusion Criteria
- •Wheelchair users who required postural support to sit upright were excluded.
Arms & Interventions
WHO 8-steps
Single group intervention and described in the Intervention section.
Intervention: The World Health Organization 8 steps for manual wheelchair service delivery (Other)
Outcomes
Primary Outcomes
Massachusetts Institute of Technology (MIT)-Wheelchair-related Health Questionnaire
Time Frame: 6 months after wheelchair delivery
This questionnaire consists of 25 questions developed to identify the reasons, consequences, and medical attention received for injuries related to the use of the wheelchair such as falls during transfers, falls during maneuvering, injuries to the shoulders, elbows, wrists, hands and back.
Wheelchair Skills Test Questionnaire
Time Frame: 6 months after wheelchair delivery
The Wheelchair Skills Test Questionnaire, (WST-Q), allows assessing the capacity and frequency with which the wheelchair user performs a series of activities safely in their wheelchair. This instrument consists of 34 questions. Answer to the capacity component can be "no" "yes" "yes, with difficulty" and "not possible with this wheelchair". Possible answers to the frequency component are "always" "sometimes" or "never". Wheelchair Skills Capacity Score is reported in percentage, possible percentage scores range from 0-100%. 0% means the participants do not have the capacity to perform any of the wheelchair skills, and 100% means the participan has the capacity to perform all skills without difficulty.
Number of days of wheelchair use
Time Frame: 3 months after wheelchair delivery
Number of days of wheelchair use
Daily distance traveled
Time Frame: 3 months after wheelchair delivery
Measured in meters per day
Average speed
Time Frame: 3 months after wheelchair delivery
Measured in meters per second
Poverty Probability Index for El Salvador
Time Frame: 6 months after wheelchair delivery
Poverty probability
WHO Quality of Life Questionnaire - Brief version
Time Frame: 6 months after wheelchair delivery
WHO Quality of Life Questionnaire - Brief version (WHOQOL-BREF) was developed to measure the quality of life of people. Its design is suitable to be used in different cultural environments with research objectives, policy making, health practices and auditing. WHOQOL-BREF is the reduced version of WHOQOL-100 and allows a complete evaluation when analyzing four fundamental domains, such as: physical, psychological, social relations and environment. It is designed in such a way that it can be answered by the participant with or without assistance. According to the information provided by the WHO, this tool has been shown to have good discriminating validity, content and reliability. The WHOQOL-BREF consists of 26 questions, but a question related to sexual activity was eliminated, because it was considered culturally inappropriate. The WHOQOL-BREF domains scores ranges from 4 to 20. A lower a score represents a worse outcome.
Massachusetts Institute of Technology (MIT)-Wheelchair-related Health Questionnaire
Time Frame: At month 0 (baseline assessment)
This questionnaire consists of 25 questions developed to identify the reasons, consequences, and medical attention received for injuries related to the use of the wheelchair such as falls during transfers, falls during maneuvering, injuries to the shoulders, elbows, wrists, hands and back.
Massachusetts Institute of Technology (MIT)-Wheelchair-related Health Questionnaire
Time Frame: At wheelchair delivery (approx. 2 months after baseline assessment)
This questionnaire consists of 25 questions developed to identify the reasons, consequences, and medical attention received for injuries related to the use of the wheelchair such as falls during transfers, falls during maneuvering, injuries to the shoulders, elbows, wrists, hands and back.
Massachusetts Institute of Technology (MIT)-Wheelchair-related Health Questionnaire
Time Frame: 3 months after wheelchair delivery
This questionnaire consists of 25 questions developed to identify the reasons, consequences, and medical attention received for injuries related to the use of the wheelchair such as falls during transfers, falls during maneuvering, injuries to the shoulders, elbows, wrists, hands and back.
Wheelchair Skills Test Questionnaire
Time Frame: At month 0 (baseline assessment)
The Wheelchair Skills Test Questionnaire, (WST-Q), allows assessing the capacity and frequency with which the wheelchair user performs a series of activities safely in their wheelchair. This instrument consists of 34 questions. Answer to the capacity component can be "no" "yes" "yes, with difficulty" and "not possible with this wheelchair". Possible answers to the frequency component are "always" "sometimes" or "never". Wheelchair Skills Capacity Score is reported in percentage, possible percentage scores range from 0-100%. 0% means the participants do not have the capacity to perform any of the wheelchair skills, and 100% means the participan has the capacity to perform all skills without difficulty.
Daily distance traveled
Time Frame: At wheelchair delivery (approx. 2 months after baseline assessment)
Measured in meters per day
Wheelchair Skills Test Questionnaire
Time Frame: 3 months after wheelchair delivery
The Wheelchair Skills Test Questionnaire, (WST-Q), allows assessing the capacity and frequency with which the wheelchair user performs a series of activities safely in their wheelchair. This instrument consists of 34 questions. Answer to the capacity component can be "no" "yes" "yes, with difficulty" and "not possible with this wheelchair". Possible answers to the frequency component are "always" "sometimes" or "never". Wheelchair Skills Capacity Score is reported in percentage, possible percentage scores range from 0-100%. 0% means the participants do not have the capacity to perform any of the wheelchair skills, and 100% means the participan has the capacity to perform all skills without difficulty.
Number of days of wheelchair use
Time Frame: At month 0 (baseline assessment)
Number of days of wheelchair use
Daily distance traveled
Time Frame: At month 0 (baseline assessment)
Measured in meters per day
Average speed
Time Frame: At month 0 (baseline assessment)
Measured in meters per second
Number of days of wheelchair use
Time Frame: At wheelchair delivery (approx. 2 months after baseline assessment)
Number of days of wheelchair use
Average speed
Time Frame: At wheelchair delivery (approx. 2 months after baseline assessment)
Measured in meters per second
Poverty Probability Index for El Salvador
Time Frame: At month 0 (baseline assessment)
Poverty probability
WHO Quality of Life Questionnaire - Brief version
Time Frame: At month 0 (baseline assessment)
WHO Quality of Life Questionnaire - Brief version (WHOQOL-BREF) was developed to measure the quality of life of people. Its design is suitable to be used in different cultural environments with research objectives, policy making, health practices and auditing. WHOQOL-BREF is the reduced version of WHOQOL-100 and allows a complete evaluation when analyzing four fundamental domains, such as: physical, psychological, social relations and environment. It is designed in such a way that it can be answered by the participant with or without assistance. According to the information provided by the WHO, this tool has been shown to have good discriminating validity, content and reliability. The WHOQOL-BREF consists of 26 questions, but a question related to sexual activity was eliminated, because it was considered culturally inappropriate. The WHOQOL-BREF domains scores ranges from 4 to 20. A lower a score represents a worse outcome.
Secondary Outcomes
- Checklist of Activities of Daily Living(6 months after wheelchair delivery)
- Wheelchair Maintenance Training Questionnaire(6 months after wheelchair delivery)
- Zarit Burden Interview - short version(6 months after wheelchair delivery)
- Breakdowns and Adverse Consequences Questionnaire(6 months after wheelchair delivery)
- Wheelchair Maintenance Training Questionnaire(At month 0 (baseline assessment))
- Wheelchair Maintenance Training Questionnaire(3 months after wheelchair delivery)
- Zarit Burden Interview - short version(At month 0 (baseline assessment))
- Zarit Burden Interview - short version(3 months after wheelchair delivery)
- Checklist of Activities of Daily Living(At month 0 (baseline assessment))
- Checklist of Activities of Daily Living(3 months after wheelchair delivery)
- Breakdowns and Adverse Consequences Questionnaire(At month 0 (baseline assessment))
- Breakdowns and Adverse Consequences Questionnaire(At wheelchair delivery (approx. 2 months after baseline assessment))
- Breakdowns and Adverse Consequences Questionnaire(3 months after wheelchair delivery)