NCT03476408

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 26, 2018

Completed
Last Updated

March 26, 2018

Status Verified

March 1, 2018

Enrollment Period

11 months

First QC Date

March 15, 2018

Last Update Submit

March 22, 2018

Conditions

Plantar SensationBalance; DistortedFallGait Disorders, Neurologic

Outcome Measures

Primary Outcomes (5)

  • Semmes-Weinstein Monofilament test

    Plantar sensation

    1 year

  • Berg Balance Scale

    Balance

    1 year

  • Tinetti Fall Risk Scale

    Risk of Falling

    1 year

  • Spinal Mouse

    Spinal flexibility for balance

    1 year

  • Walk a Line Battery

    Gait

    1 year

Study Arms (1)

Single Group Correlation

EXPERIMENTAL

Correlation between these topics.

Other: Correlation / Observational

Interventions

Correlation / ObservationalOTHER

correlation between Plantar Sensation, Balance, Risk of Falling and Gait in Patients With Schizophrenia

Single Group Correlation

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Individuals with physical and neurological comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ahi Evran University

Kırşehir, Kirşehi̇r, Turkey (Türkiye)

Location

Ahi Evran University

Kırşehir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 15, 2018

First Posted

March 26, 2018

Study Start

April 20, 2017

Primary Completion

March 15, 2018

Study Completion

March 15, 2018

Last Updated

March 26, 2018

Record last verified: 2018-03

Locations

TU(2)