Wheelchair UsersWUVNCT04936087
Effects of the WHO 8-step Wheelchair Service Delivery Process on Wheelchair Users in El Salvador: a Cohort Study
A study testing The World Health Organization 8 steps for manual wheelchair service delivery in people with Wheelchair Users, run by Momentum Wheels for Humanity at 13 sites in El Salvador.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wheelchair Users
- What is being tested?
- The World Health Organization 8 steps for manual wheelchair service delivery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 13 sitesEl Salvador
- Study dates
- 8 Jan 2019to 25 Nov 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Wheelchair users who required postural support to sit upright were excluded.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
El Salvador13 sites
Foundation Pro Rehabilitation Teleton- FUNTER Merliot
Antiguo Cuscatlán, 05001
Medical Unit Ilopango -ISSS
Ilopango, 06008
Polyclinic Hospital Planes de Renderos -ISSS
Planes de Renderos, 06015
Regional Hospital San Miguel -ISSS
San Miguel, 12017
Medical Unit 15 de Septiembre -ISSS
San Salvador, 06015
Physical Medicine and Rehabilitation Unit- ISSS
San Salvador, 06015
Foundation Pro Rehabilitation Teleton- FUNTER San Vicente
San Vicente, 10008
Santa Ana's Hospital -ISSS
Santa Ana, 02010
El Salvador's UCP Wheels for Humanity
Santa Tecla, 05009
Foundation Pro Rehabilitation Teleton- FUNTER Sonsonate
Sonsonate, 03014
Sonsonate's Regional Hospital -ISSS
Sonsonate, 03014
Usulutan's Hospital -ISSS
Usulutan, 11023
Polyclinic Hospital Zacamil -ISSS
Zacamil, 06009
About this study
Official title: Wheelchair User's Voice- A Longitudinal Study About the Impact of the WHO-8 Steps for Wheelchair Provision in El Salvador
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.
Read the 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.
Data were collected between January and November 2019, by a group of eight data collectors from the University of El Salvador.
Study participants were interviewed during the wheelchair assessment (about 2 months before wheelchair delivery), at the wheelchair delivery visit, and at 3- and 6-month follow-up visits after wheelchair delivery. Participants who were not able to attend a follow-up visit were interviewed by phone. Data were collected using the following questionnaires and tools translated into Spanish which included demographic, clinical and wheelchair-related questions, wheelchair skills, maintenance patterns, poverty probability, quality of life, and all their health related questions. Data loggers (DLs) were also used to assess number of days of wheelchair use, daily distance traveled, and speed. Caregivers were interviewed to measure caregiver burden at baseline, at 3-month follow-up, and at 6-month follow-up.
- Conditions
- Wheelchair Users
- Being tested
- The World Health Organization 8 steps for manual wheelchair service delivery
- Keywords
- manual wheelchairs, appropriate service delivery, low- and middle-income countries, global health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The World Health Organization 8 steps for manual wheelchair service deliveryOther
All study participants were provided with a new wheelchair, 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. Additionally, wheelchair maintenance reminders were sent through a text message service (SMS) to a sub-cohort of participants.
Wheelchair users were provided with one of three different, International Standards Organization (ISO) tested, wheelchair models according to the users' needs and availability: standard, active, and all-terrain models. 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.
| Study group | Role | What they receive |
|---|---|---|
| WHO 8-steps | Other | Single group intervention and described in the Intervention section. Receives: Other: The World Health Organization 8 steps for manual wheelchair service delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Massachusetts Institute of Technology (MIT)-Wheelchair-related Health Questionnaire
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.
Measured: At month 0 (baseline assessment)
Massachusetts Institute of Technology (MIT)-Wheelchair-related Health Questionnaire
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.
Measured: At wheelchair delivery (approx. 2 months after baseline assessment)
Massachusetts Institute of Technology (MIT)-Wheelchair-related Health Questionnaire
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.
Measured: 3 months after wheelchair delivery
Massachusetts Institute of Technology (MIT)-Wheelchair-related Health Questionnaire
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.
Measured: 6 months after wheelchair delivery
Wheelchair Skills Test Questionnaire
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.
Measured: At month 0 (baseline assessment)
Wheelchair Skills Test Questionnaire
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.
Measured: 3 months after wheelchair delivery
Wheelchair Skills Test Questionnaire
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.
Measured: 6 months after wheelchair delivery
Number of days of wheelchair use
Number of days of wheelchair use
Measured: At month 0 (baseline assessment)
Daily distance traveled
Measured in meters per day
Measured: At month 0 (baseline assessment)
Average speed
Measured in meters per second
Measured: At month 0 (baseline assessment)
Number of days of wheelchair use
Number of days of wheelchair use
Measured: At wheelchair delivery (approx. 2 months after baseline assessment)
Daily distance traveled
Measured in meters per day
Measured: At wheelchair delivery (approx. 2 months after baseline assessment)
Average speed
Measured in meters per second
Measured: At wheelchair delivery (approx. 2 months after baseline assessment)
Number of days of wheelchair use
Number of days of wheelchair use
Measured: 3 months after wheelchair delivery
Daily distance traveled
Measured in meters per day
Measured: 3 months after wheelchair delivery
Average speed
Measured in meters per second
Measured: 3 months after wheelchair delivery
Poverty Probability Index for El Salvador
Poverty probability
Measured: At month 0 (baseline assessment)
Poverty Probability Index for El Salvador
Poverty probability
Measured: 6 months after wheelchair delivery
WHO Quality of Life Questionnaire - Brief version
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.
Measured: At month 0 (baseline assessment)
WHO Quality of Life Questionnaire - Brief version
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.
Measured: 6 months after wheelchair delivery
Secondary outcomes (13)
Wheelchair Maintenance Training Questionnaire
The Wheelchair Maintenance Training Questionnaire (WMT-Q) is dedicated to health professionals and users of manual and power wheelchairs. This questionnaire was designed to obtain information about the frequency to which participants performed certain maintenance activities to their wheelchair. For this study only the version for manual wheelchair users was used. WMT-Q has 20 main questions. Possible answers are: "daily" "weekly" "monthly" "quarterly" "annually" "never".
Measured: At month 0 (baseline assessment)
Wheelchair Maintenance Training Questionnaire
The Wheelchair Maintenance Training Questionnaire (WMT-Q) is dedicated to health professionals and users of manual and power wheelchairs. This questionnaire was designed to obtain information about the frequency to which participants performed certain maintenance activities to their wheelchair. For this study only the version for manual wheelchair users was used. WMT-Q has 20 main questions. Possible answers are: "daily" "weekly" "monthly" "quarterly" "annually" "never".
Measured: 3 months after wheelchair delivery
Wheelchair Maintenance Training Questionnaire
The Wheelchair Maintenance Training Questionnaire (WMT-Q) is dedicated to health professionals and users of manual and power wheelchairs. This questionnaire was designed to obtain information about the frequency to which participants performed certain maintenance activities to their wheelchair. For this study only the version for manual wheelchair users was used. WMT-Q has 20 main questions. Possible answers are: "daily" "weekly" "monthly" "quarterly" "annually" "never".
Measured: 6 months after wheelchair delivery
Zarit Burden Interview - short version
The Zarit Caregiver Burden Questionnaire - short version, or better known as ZBI-12 (Zarit Burden Interview), consists of 12 questions that evaluate the burden of caregivers of people with senile dementia and people with disabilities. The ZBI assesses the caregiver's burden taking into account aspects of the caregiver's life such as family, free time and social activities. This questionnaire can be self-administered, has high content validity, high internal consistency, and great confidence of repetition. The ZBI is available in Spanish, so it can was used in El Salvador as an instrument to measure caregiver burden. ZBI Score range: 0 to 48. The higher the score, the greater the burden of care.
Measured: At month 0 (baseline assessment)
Zarit Burden Interview - short version
The Zarit Caregiver Burden Questionnaire - short version, or better known as ZBI-12 (Zarit Burden Interview), consists of 12 questions that evaluate the burden of caregivers of people with senile dementia and people with disabilities. The ZBI assesses the caregiver's burden taking into account aspects of the caregiver's life such as family, free time and social activities. This questionnaire can be self-administered, has high content validity, high internal consistency, and great confidence of repetition. The ZBI is available in Spanish, so it can was used in El Salvador as an instrument to measure caregiver burden. ZBI Score range: 0 to 48. The higher the score, the greater the burden of care.
Measured: 3 months after wheelchair delivery
Zarit Burden Interview - short version
The Zarit Caregiver Burden Questionnaire - short version, or better known as ZBI-12 (Zarit Burden Interview), consists of 12 questions that evaluate the burden of caregivers of people with senile dementia and people with disabilities. The ZBI assesses the caregiver's burden taking into account aspects of the caregiver's life such as family, free time and social activities. This questionnaire can be self-administered, has high content validity, high internal consistency, and great confidence of repetition. The ZBI is available in Spanish, so it can was used in El Salvador as an instrument to measure caregiver burden. ZBI Score range: 0 to 48. The higher the score, the greater the burden of care.
Measured: 6 months after wheelchair delivery
Checklist of Activities of Daily Living
The checklist of Activities of Daily Living is a questionnaire designed to collect information about the level of assistance provided to wheelchair users by caregivers in 17 activities of daily living. Possible responses are "Requires no assistance" "Some assistance needed" "Complete assistance needed" and "Not applicable". Responses are reported in number of activities under each level of assistance.
Measured: At month 0 (baseline assessment)
Checklist of Activities of Daily Living
The checklist of Activities of Daily Living is a questionnaire designed to collect information about the level of assistance provided to wheelchair users by caregivers in 17 activities of daily living. Possible responses are "Requires no assistance" "Some assistance needed" "Complete assistance needed" and "Not applicable". Responses are reported in number of activities under each level of assistance.
Measured: 3 months after wheelchair delivery
Checklist of Activities of Daily Living
The checklist of Activities of Daily Living is a questionnaire designed to collect information about the level of assistance provided to wheelchair users by caregivers in 17 activities of daily living. Possible responses are "Requires no assistance" "Some assistance needed" "Complete assistance needed" and "Not applicable". Responses are reported in number of activities under each level of assistance.
Measured: 6 months after wheelchair delivery
Breakdowns and Adverse Consequences Questionnaire
The Breakdowns and Adverse Consequences Questionnaire (BAC-Q) allows to collect information about the failures that occurred in the wheelchairs. BAC-Q allows knowing the failures in the tires, front wheels, the wheelchair frame, elements of postural support, seat, backrest, cushion, and it gives the opportunity to indicate another type of failure if necessary. By means of this questionnaire it is possible to know the person who carried out the repair and the consequences in the users due to wheelchair breakdowns. For example, being stranded at home or away from home, injuries due to failure, lack of school attendance, work, medical appointments, or other.
Measured: At month 0 (baseline assessment)
Breakdowns and Adverse Consequences Questionnaire
The Breakdowns and Adverse Consequences Questionnaire (BAC-Q) allows to collect information about the failures that occurred in the wheelchairs. BAC-Q allows knowing the failures in the tires, front wheels, the wheelchair frame, elements of postural support, seat, backrest, cushion, and it gives the opportunity to indicate another type of failure if necessary. By means of this questionnaire it is possible to know the person who carried out the repair and the consequences in the users due to wheelchair breakdowns. For example, being stranded at home or away from home, injuries due to failure, lack of school attendance, work, medical appointments, or other.
Measured: At wheelchair delivery (approx. 2 months after baseline assessment)
Breakdowns and Adverse Consequences Questionnaire
The Breakdowns and Adverse Consequences Questionnaire (BAC-Q) allows to collect information about the failures that occurred in the wheelchairs. BAC-Q allows knowing the failures in the tires, front wheels, the wheelchair frame, elements of postural support, seat, backrest, cushion, and it gives the opportunity to indicate another type of failure if necessary. By means of this questionnaire it is possible to know the person who carried out the repair and the consequences in the users due to wheelchair breakdowns. For example, being stranded at home or away from home, injuries due to failure, lack of school attendance, work, medical appointments, or other.
Measured: 3 months after wheelchair delivery
Breakdowns and Adverse Consequences Questionnaire
The Breakdowns and Adverse Consequences Questionnaire (BAC-Q) allows to collect information about the failures that occurred in the wheelchairs. BAC-Q allows knowing the failures in the tires, front wheels, the wheelchair frame, elements of postural support, seat, backrest, cushion, and it gives the opportunity to indicate another type of failure if necessary. By means of this questionnaire it is possible to know the person who carried out the repair and the consequences in the users due to wheelchair breakdowns. For example, being stranded at home or away from home, injuries due to failure, lack of school attendance, work, medical appointments, or other.
Measured: 6 months after wheelchair delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start8 Jan 2019
- Primary completion25 Nov 2019
- Study completion25 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wheelchair UsersStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Longitudinal within-subject design
- Masking
- None (open label)
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Momentum Wheels for Humanity
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh, Universidad de El Salvador, Google LLC.
- Responsible party
- Sponsor
- Investigators
- Jon Pearlman, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936087
- Sponsor's protocol ID
- PRO18010578
- Other IDs
- CNEIS/2018/043
- Acronym
- WUV
- Status last verified
- Jun 2021
- First submitted
- 2 Jun 2021
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected individual participant data (IDP), all IPD that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wheelchair User's Voice- A Longitudinal Study About the Impact of the WHO-8 Steps for Wheelchair Provision in El Salvador
- ClinicalTrials.gov ID
- NCT04936087
- Acronym / sponsor ID
- WUV / PRO18010578
- Conditions
- Wheelchair Users
- Keywords
- manual wheelchairs, appropriate service delivery, low- and middle-income countries, global health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Momentum Wheels for HumanityUniversity, hospital or other
- Collaborators
- University of Pittsburgh, Universidad de El Salvador, Google LLC.
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 23 Jun 2021 (actual)
- 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.
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.
Data were collected between January and November 2019, by a group of eight data collectors from the University of El Salvador.
Study participants were interviewed during the wheelchair assessment (about 2 months before wheelchair delivery), at the wheelchair delivery visit, and at 3- and 6-month follow-up visits after wheelchair delivery. Participants who were not able to attend a follow-up visit were interviewed by phone. Data were collected using the following questionnaires and tools translated into Spanish which included demographic, clinical and wheelchair-related questions, wheelchair skills, maintenance patterns, poverty probability, quality of life, and all their health related questions. Data loggers (DLs) were also used to assess number of days of wheelchair use, daily distance traveled, and speed. Caregivers were interviewed to measure caregiver burden at baseline, at 3-month follow-up, and at 6-month follow-up.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Longitudinal within-subject design
| Arm | Type | Receives |
|---|---|---|
| WHO 8-steps | Other | Other: The World Health Organization 8 steps for manual wheelchair service deliverySingle group intervention and described in the Intervention section. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Wheelchair users who required postural support to sit upright were excluded.
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 |
|---|---|---|
| The World Health Organization 8 steps for manual wheelchair service deliveryAll study participants were provided with a new wheelchair, 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. Additionally, wheelchair maintenance reminders were sent through a text message service (SMS) to a sub-cohort of participants. Wheelchair users were provided with one of three different, International Standards Organization (ISO) tested, wheelchair models according to the users' needs and availability: standard, active, and all-terrain models. 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. | Other | WHO 8-steps |
Primary 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.
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: 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.
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.
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: 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
Daily distance traveled
Time frame: At wheelchair delivery (approx. 2 months after baseline assessment)
Measured in meters per day
Average speed
Time frame: At wheelchair delivery (approx. 2 months after baseline assessment)
Measured in meters per second
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: At month 0 (baseline assessment)
Poverty probability
Poverty Probability Index for El Salvador
Time frame: 6 months after wheelchair delivery
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.
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.
13 secondary outcomes
Wheelchair Maintenance Training Questionnaire
Time frame: At month 0 (baseline assessment)
Wheelchair Maintenance Training Questionnaire
Time frame: 3 months after wheelchair delivery
Wheelchair Maintenance Training Questionnaire
Time frame: 6 months after wheelchair delivery
Zarit Burden Interview - short version
Time frame: At month 0 (baseline assessment)
Zarit Burden Interview - short version
Time frame: 3 months after wheelchair delivery
Zarit Burden Interview - short version
Time frame: 6 months after wheelchair delivery
Checklist of Activities of Daily Living
Time frame: At month 0 (baseline assessment)
Checklist of Activities of Daily Living
Time frame: 3 months after wheelchair delivery
Checklist of Activities of Daily Living
Time frame: 6 months after wheelchair delivery
Breakdowns and Adverse Consequences Questionnaire
Time frame: At month 0 (baseline assessment)
Breakdowns and Adverse Consequences Questionnaire
Time frame: At wheelchair delivery (approx. 2 months after baseline assessment)
Breakdowns and Adverse Consequences Questionnaire
Time frame: 3 months after wheelchair delivery
Breakdowns and Adverse Consequences Questionnaire
Time frame: 6 months after wheelchair delivery
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 23 Jun 2021.
- Individual participant dataSharing planned: Yes. All collected individual participant data (IDP), all IPD that underlie results in a publication.
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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.
Jon Pearlman principal investigator
University of Pittsburgh
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The World Health Organization 8 steps for manual wheelchair service delivery in people with Wheelchair Users, run by Momentum Wheels for Humanity at 13 sites in El Salvador.
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 2 inclusion and 1 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 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in El Salvador. 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?
Massachusetts Institute of Technology (MIT)-Wheelchair-related Health Questionnaire (time frame: At month 0 (baseline assessment)). The study lists 20 primary outcomes in all. 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 23 Jun 2021.