Plantar SensationNCT03476408
Plantar Sensation, Balance, Risk of Falling and Gait in Patients With Schizophrenia
A study testing Correlation / Observational in people with Plantar Sensation and Balance; Distorted, run by Hacettepe University at 2 sites in Turkey (Türkiye).
Trial summary
Cerebellar vermis anomalies are present in schizophrenic individuals. This condition leads to postural balance problems. Foot and ankle complex have a special role for maintaining balance. However, there is no study about this topic in schizophrenic individuals. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Plantar Sensation, Balance; Distorted, Fall
- What is being tested?
- Correlation / Observational
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 20 Apr 2017to 15 Mar 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 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- diagnose of schizophrenia according to DSM-5
- being an individual in remission against the risk of having an attack
- individuals who use the same psychotropic drugs for at least 4 weeks
Who cannot join
- Individuals with physical and neurological comorbidities
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ahi Evran University
Kırşehir, Kirşehi̇r
Ahi Evran University
Kırşehir
About this study
Official title: Investigation of the Relationship Between Plantar Sensation, Balance, Risk of Falling and Gait in Patients With Schizophrenia
Cerebellar vermis anomalies are present in schizophrenic individuals. This condition leads to postural balance problems. Foot and ankle complex have a special role for maintaining balance. However, there is no study about this topic in schizophrenic individuals.
- Being tested
- Correlation / Observational
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Correlation / ObservationalOther
correlation between Plantar Sensation, Balance, Risk of Falling and Gait in Patients With Schizophrenia
| Study group | Role | What they receive |
|---|---|---|
| Single Group Correlation | Experimental | Correlation between these topics. Receives: Other: Correlation / Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semmes-Weinstein Monofilament test
Plantar sensation
Measured: 1 year
Berg Balance Scale
Balance
Measured: 1 year
Tinetti Fall Risk Scale
Risk of Falling
Measured: 1 year
Spinal Mouse
Spinal flexibility for balance
Measured: 1 year
Walk a Line Battery
Gait
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 posted26 Mar 2018
- Study start20 Apr 2017
- Primary completion15 Mar 2018
- Study completion15 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar SensationStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caner Karartı, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476408
- Sponsor's protocol ID
- 2018100
- Status last verified
- Mar 2018
- First submitted
- 15 Mar 2018
- Last updated
- 26 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Plantar Sensation, Balance, Risk of Falling and Gait in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT03476408
- Acronym / sponsor ID
- 2018100
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 15 Mar 2018 (actual)
- Study completion
- 15 Mar 2018 (actual)
- First posted
- 26 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.
Cerebellar vermis anomalies are present in schizophrenic individuals. This condition leads to postural balance problems. Foot and ankle complex have a special role for maintaining balance. However, there is no study about this topic in schizophrenic individuals.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group Correlation | Experimental | Other: Correlation / ObservationalCorrelation between these topics. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- diagnose of schizophrenia according to DSM-5
- being an individual in remission against the risk of having an attack
- individuals who use the same psychotropic drugs for at least 4 weeks
Key exclusion criteria (1 listed)
- Individuals with physical and neurological comorbidities
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 |
|---|---|---|
| Correlation / Observationalcorrelation between Plantar Sensation, Balance, Risk of Falling and Gait in Patients With Schizophrenia | Other | Single Group Correlation |
Primary outcome
Semmes-Weinstein Monofilament test
Time frame: 1 year
Plantar sensation
Berg Balance Scale
Time frame: 1 year
Balance
Tinetti Fall Risk Scale
Time frame: 1 year
Risk of Falling
Spinal Mouse
Time frame: 1 year
Spinal flexibility for balance
Walk a Line Battery
Time frame: 1 year
Gait
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 26 Mar 2018.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Correlation / Observational in people with Plantar Sensation and Balance; Distorted, run by Hacettepe University at 2 sites 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 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 26 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 2 sites 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?
Semmes-Weinstein Monofilament test (time frame: 1 year). The study lists 5 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 26 Mar 2018.