- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03476408
Plantar Sensation, Balance, Risk of Falling and Gait in Patients With Schizophrenia
March 22, 2018 updated by: Caner Karartı, Hacettepe University
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kırşehir, Turkey
- Ahi Evran University
-
-
Kirşehi̇r
-
Kırşehir, Kirşehi̇r, Turkey
- Ahi Evran University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Individuals with physical and neurological comorbidities
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single Group Correlation
Correlation between these topics.
|
correlation between Plantar Sensation, Balance, Risk of Falling and Gait in Patients With Schizophrenia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Semmes-Weinstein Monofilament test
Time Frame: 1 year
|
Plantar sensation
|
1 year
|
Berg Balance Scale
Time Frame: 1 year
|
Balance
|
1 year
|
Tinetti Fall Risk Scale
Time Frame: 1 year
|
Risk of Falling
|
1 year
|
Spinal Mouse
Time Frame: 1 year
|
Spinal flexibility for balance
|
1 year
|
Walk a Line Battery
Time Frame: 1 year
|
Gait
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 20, 2017
Primary Completion (Actual)
March 15, 2018
Study Completion (Actual)
March 15, 2018
Study Registration Dates
First Submitted
March 15, 2018
First Submitted That Met QC Criteria
March 22, 2018
First Posted (Actual)
March 26, 2018
Study Record Updates
Last Update Posted (Actual)
March 26, 2018
Last Update Submitted That Met QC Criteria
March 22, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018100
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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