Mobility LimitationNCT04074252
Mobility Impairment in the Northern Region of Malawi
A study testing Lofstrand Crutches and Axillary Crutches in people with Mobility Limitation, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The purpose of this study is to investigate whether Lofstrand or axillary crutches are better suited to treat mobility impairments and improve physical activity levels in rural, resource-limited, settings like the Northern Region of Malawi. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Mobility Limitation
- What is being tested?
- Lofstrand Crutches and Axillary Crutches
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 15 Jul 2022
- 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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Persons fluent in English, Tumbuka, and/or Chichewa.
- Persons diagnosed with a moderate to severe mobility impairment and/or lower extremity disabilities as determined by the WGES Questions on Disability.
- Persons untreated or undertreated for mobility impairment. We consider undertreated persons as those treating their mobility impairments with self-made devices (i.e. wooden crutches or walking sticks), or with devices considered lower than standard of care for their level of impairment (i.e. using a cane instead of crutches).
- Persons who are candidates for both axillary and Lofstrand crutch treatment - as determined by gait analysis conducted by local physiotherapists.
- Persons accessing one of the following 15 outreach distribution clinics located throughout the Mzimba, Rumphi, and Nkhata Bay Districts: Mzuzu Central Hospital, Ekwendeni Mission Hospital, Mtwalo Health Centre, Rumphi MAP Office, Bolero Health Centre, Hewe Health Centre, Livingstonia Mission Hospital, Mhuju Health Centre, Mzimba District Hospital, Jenda Health Centre, Nkhata Bay District Hospital, Mpamba Health Centre, Maula Health Centre, Chintheche Health Centre, and Kande Health Centre.
Who cannot join
- Persons diagnosed with degenerative conditions that may lead to further deterioration in mobility between data collection periods (i.e. ALS, Muscular Dystrophy, Corticobasal Degeneration etc.)
- Persons with developmental delays that will preclude them from participation in any of the surveys
- Persons with upper extremity disabilities that may preclude them from using crutches.
- Persons who are not permanent residents of the area or have any plans on moving out of the area.
Trial locations and contacts
1 site in 1 country.
United States1 site
Orthopaedic Institute for Children
Los Angeles, California, 90007
About this study
Official title: Coupling the Surveillance of Mobility Impaired Adults With Large-Scale Assistive Device Donations and the Suitability of the Long-Term Use of Lofstrand (Forearm) Versus Axillary (Underarm) Crutches Among Mobility Impaired Adults in the Northern Region of Malawi
The purpose of this study is to investigate whether Lofstrand or axillary crutches are better suited to treat mobility impairments and improve physical activity levels in rural, resource-limited, settings like the Northern Region of Malawi. To do this, we are proposing the implementation of a randomized controlled trial (RCT) to measure and compare the physical activity and satisfaction of mobility aid recipients sorted into two groups - one receiving a set of Lofstrand crutches (Group 1) and the other a set of axillary crutches (Group 2). Changes in physical activity, disability, and life satisfaction levels will measured with a follow-up data collection period conducted one year after the distribution of the devices.
Read the detailed description
STAGE 1 - BASELINE DATA COLLECTION:
- Potential participants will be identified at outreach clinics in the Mzimba, Rumphi, and Nkhata Bay Districts for participation in the study.
- Potential participants will take the Washington Group Extended Set Questions on Disability (WGES) and those that meet a baseline level of disability/mobility impairment - validated by physiotherapist opinion - are invited to participate in the study.
- 100 or more participants (50+ per group) who fulfill the inclusion criteria will be selected for participation.
- Participants will complete a Demographic Survey to determine their age, gender, health barriers, social determinants of health etc.
- Participants will complete the Global Physical Activity Questionnaire (GPAQ) to determine a baseline of their physical activity.
- Participants will complete the PROMIS Satisfaction with Participation in Social Roles - Short Form 8a (SPSR) and General Life Satisfaction (Ages 18+) - Fixed Form A (GLS) questionnaires to determine a baseline of their overall life satisfaction.
- Treatment groups will be randomized through the use of randomization envelopes.
- Selected devices, as determined in the randomization process, will be distributed to participants in each treatment group.
- The addresses/villages of residences of selected participants will be recorded and marked manually on a detailed satellite map. A list of study participants will be provided to the local Health Surveillance Assistant (HSA) for record keeping and monitoring purposes. (HSAs have intimate knowledge of the communities they serve and will be useful partners to help find participants in the follow-up stages of the trial.)
STAGE 2 - ONE-YEAR FOLLOW-UP DATA COLLECTION:
- Participants will be located using the assistance of the local HSA, address records, and map markings from Stage 1.
- Participants will complete follow-up SPSR, GLS, WGES and GPAQ questionnaires, and will complete the Crutch Satisfaction Survey.
- Reports of missing and damaged crutches will be taken.
STAGE 3 - DATA ANALYSIS:
The two study groups will be compared using the following metrics:
- Stratified by level of disability based on Washington Group Extended Set Questions on Disability
- Changes in GLS and SPSR scores between baseline and follow-up data collection will be used to determine changes in participants' overall life satisfaction.
- Changes in Global Physical Activity Questionnaire scores between baseline and follow-up data collection will be used to determine changes in participants' mobility impairments and day-to-day activity levels.
- Scores from the Crutch Satisfaction Survey will be used determine participants' subjective experiences with their respective mobility devices.
- Conditions
- Mobility Limitation
- Being tested
- Lofstrand Crutches, Axillary Crutches
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lofstrand CrutchesDevice
Device: Set of Lofstrand Crutches
Axillary CrutchesDevice
Device: Set of Axillary Crutches
| Study group | Role | What they receive |
|---|---|---|
| Lofstrand Crutches | Active comparator | This group is given a set of Lofstrand crutches. Receives: Device: Lofstrand Crutches |
| Axillary Crutches | Active comparator | This group is given a set of axillary crutches. Receives: Device: Axillary Crutches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in scores between baseline and follow-up from the Global Physical Activity Questionnaire (QPAQ)
Questionnaire used to measure the patient's self reported level of physical activity. There are 16 questions total. The majority of the questions are binary, but there are a few questions that include a measurement of time (in minutes, hours, and days). There is a numerical output.
Measured: Baseline and 1 year
Secondary outcomes (3)
Change in scores between baseline and follow-up from the PROMIS Satisfaction with Participation in Social Roles (SPSR) survey
Questionnaire used to measure the patient's self reported level of satisfaction with current social roles. There are 7 ordinal type questions, each with 5 different rating options to choose from. There is a numerical output.
Measured: Baseline and 1 year
Change in scores between baseline and follow-up from the PROMIS General Life Satisfaction (GLS) survey
Questionnaire used to measure the patient's self reported level of satisfaction with general life satisfaction. There are 7 ordinal type questions, each with 5 different rating options to choose from. There is a numerical output.
Measured: Baseline and 1 year
Satisfaction Survey
Questionnaire used to measure the patient's self reported satisfaction with their assigned devices. There is a numerical output.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start1 May 2019
- Primary completion15 Jul 2022
- Study completion15 Jul 2022
Why it stopped: Unable to complete intervention due to logistics.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mobility LimitationStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Project Malawi
- Responsible party
- Principal investigator, Rachel Thompson, MD, University of California, Los Angeles
- Investigators
- Rachel M Thompson, MD, Principal investigator, UCLA/OIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074252
- Sponsor's protocol ID
- 19-000773
- Status last verified
- Jul 2023
- First submitted
- 10 Jun 2019
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coupling the Surveillance of Mobility Impaired Adults With Large-Scale Assistive Device Donations and the Suitability of the Long-Term Use of Lofstrand (Forearm) Versus Axillary (Underarm) Crutches Among Mobility Impaired Adults in the Northern Region of Malawi
- ClinicalTrials.gov ID
- NCT04074252
- Acronym / sponsor ID
- 19-000773
- Conditions
- Mobility Limitation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to complete intervention due to logistics.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Project Malawi
- Study start
- 1 May 2019 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 30 Aug 2019 (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 purpose of this study is to investigate whether Lofstrand or axillary crutches are better suited to treat mobility impairments and improve physical activity levels in rural, resource-limited, settings like the Northern Region of Malawi. To do this, we are proposing the implementation of a randomized controlled trial (RCT) to measure and compare the physical activity and satisfaction of mobility aid recipients sorted into two groups - one receiving a set of Lofstrand crutches (Group 1) and the other a set of axillary crutches (Group 2). Changes in physical activity, disability, and life satisfaction levels will measured with a follow-up data collection period conducted one year after the distribution of the devices.
Detailed description
STAGE 1 - BASELINE DATA COLLECTION:
- Potential participants will be identified at outreach clinics in the Mzimba, Rumphi, and Nkhata Bay Districts for participation in the study.
- Potential participants will take the Washington Group Extended Set Questions on Disability (WGES) and those that meet a baseline level of disability/mobility impairment - validated by physiotherapist opinion - are invited to participate in the study.
- 100 or more participants (50+ per group) who fulfill the inclusion criteria will be selected for participation.
- Participants will complete a Demographic Survey to determine their age, gender, health barriers, social determinants of health etc.
- Participants will complete the Global Physical Activity Questionnaire (GPAQ) to determine a baseline of their physical activity.
- Participants will complete the PROMIS Satisfaction with Participation in Social Roles - Short Form 8a (SPSR) and General Life Satisfaction (Ages 18+) - Fixed Form A (GLS) questionnaires to determine a baseline of their overall life satisfaction.
- Treatment groups will be randomized through the use of randomization envelopes.
- Selected devices, as determined in the randomization process, will be distributed to participants in each treatment group.
- The addresses/villages of residences of selected participants will be recorded and marked manually on a detailed satellite map. A list of study participants will be provided to the local Health Surveillance Assistant (HSA) for record keeping and monitoring purposes. (HSAs have intimate knowledge of the communities they serve and will be useful partners to help find participants in the follow-up stages of the trial.)
STAGE 2 - ONE-YEAR FOLLOW-UP DATA COLLECTION:
- Participants will be located using the assistance of the local HSA, address records, and map markings from Stage 1.
- Participants will complete follow-up SPSR, GLS, WGES and GPAQ questionnaires, and will complete the Crutch Satisfaction Survey.
- Reports of missing and damaged crutches will be taken.
STAGE 3 - DATA ANALYSIS:
The two study groups will be compared using the following metrics:
- Stratified by level of disability based on Washington Group Extended Set Questions on Disability
- Changes in GLS and SPSR scores between baseline and follow-up data collection will be used to determine changes in participants' overall life satisfaction.
- Changes in Global Physical Activity Questionnaire scores between baseline and follow-up data collection will be used to determine changes in participants' mobility impairments and day-to-day activity levels.
- Scores from the Crutch Satisfaction Survey will be used determine participants' subjective experiences with their respective mobility devices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lofstrand Crutches | Active comparator | Device: Lofstrand CrutchesThis group is given a set of Lofstrand crutches. |
| Axillary Crutches | Active comparator | Device: Axillary CrutchesThis group is given a set of axillary crutches. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Persons fluent in English, Tumbuka, and/or Chichewa.
- Persons diagnosed with a moderate to severe mobility impairment and/or lower extremity disabilities as determined by the WGES Questions on Disability.
- Persons untreated or undertreated for mobility impairment. We consider undertreated persons as those treating their mobility impairments with self-made devices (i.e. wooden crutches or walking sticks), or with devices considered lower than standard of care for their level of impairment (i.e. using a cane instead of crutches).
- Persons who are candidates for both axillary and Lofstrand crutch treatment - as determined by gait analysis conducted by local physiotherapists.
- Persons accessing one of the following 15 outreach distribution clinics located throughout the Mzimba, Rumphi, and Nkhata Bay Districts: Mzuzu Central Hospital, Ekwendeni Mission Hospital, Mtwalo Health Centre, Rumphi MAP Office, Bolero Health Centre, Hewe Health Centre, Livingstonia Mission Hospital, Mhuju Health Centre, Mzimba District Hospital, Jenda Health Centre, Nkhata Bay District Hospital, Mpamba Health Centre, Maula Health Centre, Chintheche Health Centre, and Kande Health Centre.
Key exclusion criteria (4 listed)
- Persons diagnosed with degenerative conditions that may lead to further deterioration in mobility between data collection periods (i.e. ALS, Muscular Dystrophy, Corticobasal Degeneration etc.)
- Persons with developmental delays that will preclude them from participation in any of the surveys
- Persons with upper extremity disabilities that may preclude them from using crutches.
- Persons who are not permanent residents of the area or have any plans on moving out of the area.
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 |
|---|---|---|
| Lofstrand CrutchesDevice: Set of Lofstrand Crutches | Device | Lofstrand Crutches |
| Axillary CrutchesDevice: Set of Axillary Crutches | Device | Axillary Crutches |
Primary outcome
Change in scores between baseline and follow-up from the Global Physical Activity Questionnaire (QPAQ)
Time frame: Baseline and 1 year
Questionnaire used to measure the patient's self reported level of physical activity. There are 16 questions total. The majority of the questions are binary, but there are a few questions that include a measurement of time (in minutes, hours, and days). There is a numerical output.
3 secondary outcomes
Change in scores between baseline and follow-up from the PROMIS Satisfaction with Participation in Social Roles (SPSR) survey
Time frame: Baseline and 1 year
Change in scores between baseline and follow-up from the PROMIS General Life Satisfaction (GLS) survey
Time frame: Baseline and 1 year
Satisfaction Survey
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
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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.
Rachel M Thompson, MD principal investigator
UCLA/OIC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lofstrand Crutches and Axillary Crutches in people with Mobility Limitation, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 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: withdrawn, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in scores between baseline and follow-up from the Global Physical Activity Questionnaire (QPAQ) (time frame: Baseline and 1 year). 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 12 Jul 2023.