Wheelchair Users Clinical Trial
— WUVOfficial title:
Wheelchair User's Voice- A Longitudinal Study About the Impact of the WHO-8 Steps for Wheelchair Provision in El Salvador
Verified date | June 2021 |
Source | Momentum Wheels for Humanity |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 264 |
Est. completion date | November 25, 2019 |
Est. primary completion date | November 25, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
El Salvador | Foundation Pro Rehabilitation Teleton- FUNTER Merliot | Antiguo Cuscatlán | |
El Salvador | Medical Unit Ilopango -ISSS | Ilopango | |
El Salvador | Polyclinic Hospital Planes de Renderos -ISSS | Planes de Renderos | |
El Salvador | Regional Hospital San Miguel -ISSS | San Miguel | |
El Salvador | Medical Unit 15 de Septiembre -ISSS | San Salvador | |
El Salvador | Physical Medicine and Rehabilitation Unit- ISSS | San Salvador | |
El Salvador | Foundation Pro Rehabilitation Teleton- FUNTER San Vicente | San Vicente | |
El Salvador | Santa Ana's Hospital -ISSS | Santa Ana | |
El Salvador | El Salvador's UCP Wheels for Humanity | Santa Tecla | |
El Salvador | Foundation Pro Rehabilitation Teleton- FUNTER Sonsonate | Sonsonate | |
El Salvador | Sonsonate's Regional Hospital -ISSS | Sonsonate | |
El Salvador | Usulutan's Hospital -ISSS | Usulutan | |
El Salvador | Polyclinic Hospital Zacamil -ISSS | Zacamil |
Lead Sponsor | Collaborator |
---|---|
Momentum Wheels for Humanity | Google LLC., Universidad de El Salvador, University of Pittsburgh |
El Salvador,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | At month 0 (baseline assessment) | |
Primary | 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. | At wheelchair delivery (approx. 2 months after baseline assessment) | |
Primary | 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. | 3 months after wheelchair delivery | |
Primary | 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. | 6 months after wheelchair delivery | |
Primary | 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. | At month 0 (baseline assessment) | |
Primary | 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. | 3 months after wheelchair delivery | |
Primary | 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. | 6 months after wheelchair delivery | |
Primary | Number of days of wheelchair use | Number of days of wheelchair use | At month 0 (baseline assessment) | |
Primary | Daily distance traveled | Measured in meters per day | At month 0 (baseline assessment) | |
Primary | Average speed | Measured in meters per second | At month 0 (baseline assessment) | |
Primary | Number of days of wheelchair use | Number of days of wheelchair use | At wheelchair delivery (approx. 2 months after baseline assessment) | |
Primary | Daily distance traveled | Measured in meters per day | At wheelchair delivery (approx. 2 months after baseline assessment) | |
Primary | Average speed | Measured in meters per second | At wheelchair delivery (approx. 2 months after baseline assessment) | |
Primary | Number of days of wheelchair use | Number of days of wheelchair use | 3 months after wheelchair delivery | |
Primary | Daily distance traveled | Measured in meters per day | 3 months after wheelchair delivery | |
Primary | Average speed | Measured in meters per second | 3 months after wheelchair delivery | |
Primary | Poverty Probability Index for El Salvador | Poverty probability | At month 0 (baseline assessment) | |
Primary | Poverty Probability Index for El Salvador | Poverty probability | 6 months after wheelchair delivery | |
Primary | 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. |
At month 0 (baseline assessment) | |
Primary | 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. |
6 months after wheelchair delivery | |
Secondary | 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". | At month 0 (baseline assessment) | |
Secondary | 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". | 3 months after wheelchair delivery | |
Secondary | 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". | 6 months after wheelchair delivery | |
Secondary | 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. | At month 0 (baseline assessment) | |
Secondary | 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. | 3 months after wheelchair delivery | |
Secondary | 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. | 6 months after wheelchair delivery | |
Secondary | 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. | At month 0 (baseline assessment) | |
Secondary | 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. | 3 months after wheelchair delivery | |
Secondary | 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. | 6 months after wheelchair delivery | |
Secondary | 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. | At month 0 (baseline assessment) | |
Secondary | 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. | At wheelchair delivery (approx. 2 months after baseline assessment) | |
Secondary | 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. | 3 months after wheelchair delivery | |
Secondary | 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. | 6 months after wheelchair delivery |
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