DiabetesWELSHNCT03482869
Evaluation of Self-reported Walking Impairment in Predominantly Illiterate Patients
A study testing walking ability in people with Diabetes, run by Université Polytechnique de Bobo-Dioulasso at 1 site in Burkina Faso.
Trial summary
The purpose of this study is to test the routine feasibility of an image tool adapted from the WELCH questionnaire ( Walking estimated limitation calculated by history) to estimate walking impairment (The WELSH questionnaire: Walking estimated limitation stated by history) in patients investigated for walking… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- walking ability
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBurkina Faso
- Study dates
- 30 Mar 2018to 30 Aug 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- •Signed consent for the data treatment as a database
Who cannot join
- Rebuttal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Walking Estimated Limitation Stated by History (WELSH): A Visual Tool to Self-report Walking Impairment From a Predominantly Illiterate Diabetic Population.
The purpose of this study is to test the routine feasibility of an image tool adapted from the WELCH questionnaire ( Walking estimated limitation calculated by history) to estimate walking impairment (The WELSH questionnaire: Walking estimated limitation stated by history) in patients investigated for walking impairment. Secondary aims correlation with the maximal walking distance.
Read the detailed description
The WELSH is self completed by the patients and scored by the physician after self-completion. Patients perform a 6 minutes walking test on a 30m corridor
- Conditions
- Diabetes
- Being tested
- walking ability
- Keywords
- walking impairment, disability, diabetes mellitus
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
walking abilityDiagnostic test
Included patients will perform a 6 min walk test
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients | Experimental | Patients referred for the equilibrium or diagnosis of diabetes mellitus will be proposed to participate and estimate their walking ability with the WELSH (Walking estimated limitation stated by History) based solely on images Receives: Diagnostic Test: walking ability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal walking distance
Maximal measured distance will be the distance walked during a 6 min walk tests
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start30 Mar 2018 (estimated)
- Primary completion30 Aug 2018 (estimated)
- Study completion30 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Polytechnique de Bobo-Dioulasso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nafi OUEDRAOGO, Université Polytechnique de Bobo-Dioulasso
- Investigators
- Nafi OUEDRAOGO, Principal investigator, CHU Souro Sanou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482869
- Sponsor's protocol ID
- Bobo 2018-001
- Acronym
- WELSH
- Status last verified
- Mar 2018
- First submitted
- 14 Mar 2018
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Probably available upon request. Undecided yet
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Walking Estimated Limitation Stated by History (WELSH): A Visual Tool to Self-report Walking Impairment From a Predominantly Illiterate Diabetic Population.
- ClinicalTrials.gov ID
- NCT03482869
- Acronym / sponsor ID
- WELSH / Bobo 2018-001
- Conditions
- Diabetes
- Keywords
- walking impairment, disability, diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Université Polytechnique de Bobo-DioulassoUniversity, hospital or other
- Study start
- 30 Mar 2018 (estimated)
- Primary completion
- 30 Aug 2018 (estimated)
- Study completion
- 30 Aug 2018 (estimated)
- First posted
- 29 Mar 2018 (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 test the routine feasibility of an image tool adapted from the WELCH questionnaire ( Walking estimated limitation calculated by history) to estimate walking impairment (The WELSH questionnaire: Walking estimated limitation stated by history) in patients investigated for walking impairment. Secondary aims correlation with the maximal walking distance.
Detailed description
The WELSH is self completed by the patients and scored by the physician after self-completion. Patients perform a 6 minutes walking test on a 30m corridor
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients | Experimental | Diagnostic Test: walking abilityPatients referred for the equilibrium or diagnosis of diabetes mellitus will be proposed to participate and estimate their walking ability with the WELSH (Walking estimated limitation stated by History) based solely on images |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- •Signed consent for the data treatment as a database
Key exclusion criteria (1 listed)
- Rebuttal to participate
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 |
|---|---|---|
| walking abilityIncluded patients will perform a 6 min walk test | Diagnostic test | Diabetic patients |
Primary outcome
Maximal walking distance
Time frame: 10 minutes
Maximal measured distance will be the distance walked during a 6 min walk tests
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Individual participant dataSharing planned: Undecided. Probably available upon request. Undecided yet
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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.
Nafi OUEDRAOGO principal investigator
CHU Souro Sanou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing walking ability in people with Diabetes, run by Université Polytechnique de Bobo-Dioulasso at 1 site in Burkina Faso.
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 1 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: status not confirmed, as of the sponsor's last update on 29 Mar 2018. 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 Burkina Faso. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nafi OUEDRAOGO, MD (+22670155806, Nafioued@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal walking distance (time frame: 10 minutes). 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 29 Mar 2018.