Back to resultsPlantar Sensation, Balance, Risk of Falling and Gait in Patients With Schizophrenia
Primary Purpose
Plantar Sensation, Balance; Distorted, Fall
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Correlation / Observational
Sponsored by
About this trial
This is an interventional health services research trial for Plantar Sensation
Eligibility Criteria
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
Sites / Locations
- Ahi Evran University
- Ahi Evran University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Group Correlation
Arm Description
Correlation between these topics.
Outcomes
Primary Outcome Measures
Semmes-Weinstein Monofilament test
Plantar sensation
Berg Balance Scale
Balance
Tinetti Fall Risk Scale
Risk of Falling
Spinal Mouse
Spinal flexibility for balance
Walk a Line Battery
Gait
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03476408
Brief Title
Plantar Sensation, Balance, Risk of Falling and Gait in Patients With Schizophrenia
Official Title
Investigation of the Relationship Between Plantar Sensation, Balance, Risk of Falling and Gait in Patients With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
April 20, 2017 (Actual)
Primary Completion Date
March 15, 2018 (Actual)
Study Completion Date
March 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Sensation, Balance; Distorted, Fall, Gait Disorders, Neurologic
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Group Correlation
Arm Type
Experimental
Arm Description
Correlation between these topics.
Intervention Type
Other
Intervention Name(s)
Correlation / Observational
Intervention Description
correlation between Plantar Sensation, Balance, Risk of Falling and Gait in Patients With Schizophrenia
Primary Outcome Measure Information:
Title
Semmes-Weinstein Monofilament test
Description
Plantar sensation
Time Frame
1 year
Title
Berg Balance Scale
Description
Balance
Time Frame
1 year
Title
Tinetti Fall Risk Scale
Description
Risk of Falling
Time Frame
1 year
Title
Spinal Mouse
Description
Spinal flexibility for balance
Time Frame
1 year
Title
Walk a Line Battery
Description
Gait
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Ahi Evran University
City
Kırşehir
State/Province
Kirşehi̇r
Country
Turkey
Facility Name
Ahi Evran University
City
Kırşehir
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Plantar Sensation, Balance, Risk of Falling and Gait in Patients With Schizophrenia
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