Gait Disorder, SensorimotorNCT04758364
Factors That Effect the Gait Speed in Diabetic Individuals Without Neuropathy
An observational study of Gait Disorder, Sensorimotor and Diabetes Mellitus, Type 2, run by GULIN FINDIKOGLU at 1 site in Turkey (Türkiye).
Trial summary
This study planned to investigate the role of potential explanatory factors effecting the speed of gait such as muscle mass, aerobic capacity, physical activity status, cognitive function, blood pressure, and metabolic measures considering age, sex, and education years in diabetic individuals without neuropathy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gait Disorder, Sensorimotor, Diabetes Mellitus, Type 2
- What is being tested?
- measurement of gait speed
- How many people
- 71 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2021to 30 Mar 2021
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type 2 Diabetic individuals without neuropathy
Who may be able to join
- Individuals with Diabetes Mellitus less than 10 years but longer than 1 year
- Absence of neuropathic symptoms
- DN4 questionnaire sore less than 4
Who cannot join
- Individuals who had
- insulin therapy,
- poor glycemic control,
- manifesting cardiovascular disease,
- retinopathy or other visual problems,
- diabetic neuropathy,
Show all 17Show fewer
- nephropathy,
- cerebrovascular disease,
- cognitive impairment,
- heart failure,
- alcohol or cigarette dependence,
- cancer,
- chemo/radiotherapy,
- foot ulcer,
- orthopedical or surgical problems
- wheel-chair or any assistive devices for ambulation
- prominent knee or hip arthritis, prosthesis
Trial locations and contacts
1 site in 1 country.
About this study
This study planned to investigate the role of potential explanatory factors effecting the speed of gait such as muscle mass, aerobic capacity, physical activity status, cognitive function, blood pressure, and metabolic measures considering age, sex, and education years in diabetic individuals without neuropathy.
Read the detailed description
Type 2 diabetic people will be screened by clinical symptoms of neuropathy and DN4 questionnaire. Among those who did not have neuropathic symptoms or who have DN4 score below 4 will be considered for the study.Then aerobic capacity will be measured by a cycle ergometer and VO2max will be obtained. Weight, body mass index and muscle mass will be measured by bioimpedance analysis. Physical activity status will be determined by International Physical Activity Score (IPAQ). Cognitive function will be evaluated by Mini Mental test. HbA1c and fasting blood glucose will be measured in venous blood after overnight fasting. Blood pressure will be measured in the sitting position after resting from the left arm. Speed of gait will be measured by an accelerometer.Then, the effect of above mentioned factors on speed of gait will be studied.
- Being tested
- measurement of gait speed
- Keywords
- Mini-Mental State Examination, gait, aerobic capacity, HbA1c, muscle, hypertension, glucose
- Medical subject headings
- Gait Disorders, Neurologic, Diabetes Mellitus, Type 2, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of gait speedOther
Also called measurement of aerobic capacity, measurement of muscle mass, measurement of blood glucose and HbA1c, cognitive function testing
Cross sectional, cohort
What is being measured
The primary outcome is the main question the study is designed to answer.
gait speed
gait speed measured by wearable accelerometer
Measured: The gait speed will be measured once within a month after the participants enrolled.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start20 Feb 2021
- Primary completion12 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait Disorder, SensorimotorStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- GULIN FINDIKOGLU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, GULIN FINDIKOGLU, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758364
- Sponsor's protocol ID
- 60116787-020/75097
- Status last verified
- Mar 2021
- First submitted
- 11 Feb 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors That Effect the Gait Speed in Diabetic Individuals Without Neuropathy
- ClinicalTrials.gov ID
- NCT04758364
- Acronym / sponsor ID
- 60116787-020/75097
- Keywords
- Mini-Mental State Examination, gait, aerobic capacity, HbA1c, muscle, hypertension, glucose
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- GULIN FINDIKOGLUUniversity, hospital or other
- Study start
- 20 Feb 2021 (actual)
- Primary completion
- 12 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 17 Feb 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.
This study planned to investigate the role of potential explanatory factors effecting the speed of gait such as muscle mass, aerobic capacity, physical activity status, cognitive function, blood pressure, and metabolic measures considering age, sex, and education years in diabetic individuals without neuropathy.
Detailed description
Type 2 diabetic people will be screened by clinical symptoms of neuropathy and DN4 questionnaire. Among those who did not have neuropathic symptoms or who have DN4 score below 4 will be considered for the study.Then aerobic capacity will be measured by a cycle ergometer and VO2max will be obtained. Weight, body mass index and muscle mass will be measured by bioimpedance analysis. Physical activity status will be determined by International Physical Activity Score (IPAQ). Cognitive function will be evaluated by Mini Mental test. HbA1c and fasting blood glucose will be measured in venous blood after overnight fasting. Blood pressure will be measured in the sitting position after resting from the left arm. Speed of gait will be measured by an accelerometer.Then, the effect of above mentioned factors on speed of gait will be studied.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 2 Diabetic individuals without neuropathy
Key inclusion criteria (3 listed)
- Individuals with Diabetes Mellitus less than 10 years but longer than 1 year
- Absence of neuropathic symptoms
- DN4 questionnaire sore less than 4
Key exclusion criteria (17 listed)
- Individuals who had
- insulin therapy,
- poor glycemic control,
- manifesting cardiovascular disease,
- retinopathy or other visual problems,
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 |
|---|---|---|
| measurement of gait speedAlso: measurement of aerobic capacity, measurement of muscle mass, measurement of blood glucose and HbA1c, cognitive function testingCross sectional, cohort | Other | – |
Primary outcome
gait speed
Time frame: The gait speed will be measured once within a month after the participants enrolled.
gait speed measured by wearable accelerometer
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 1 Apr 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gait Disorder, Sensorimotor and Diabetes Mellitus, Type 2, run by GULIN FINDIKOGLU at 1 site in Turkey (Türkiye).
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 3 inclusion and 17 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 1 Apr 2021. 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 Turkey (Türkiye). 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?
gait speed (time frame: The gait speed will be measured once within a month after the participants enrolled.). 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 1 Apr 2021.