CClinicalTrials.gg
CompletedNCT03476408Updated Mar 26, 2018

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

An interventional study of Correlation / Observational in Plantar Sensation, Balance; Distorted and Fall, sponsored by Hacettepe University. Completed at 2 sites in Turkey. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-26.

Sponsored by Hacettepe University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Not applicable
Ages
18 Years to 64 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Plantar Sensation
  • Balance; Distorted
  • Fall
  • Gait Disorders, Neurologic
03

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Individuals with physical and neurological comorbidities
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    Single Group Correlation

    Correlation between these topics.

    Other: Correlation / Observational

Interventions

  • OtherCorrelation / Observational

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

05

What researchers measure

Primary outcomes

  1. Semmes-Weinstein Monofilament test

    Plantar sensation

    Time frame: 1 year

  2. Berg Balance Scale

    Balance

    Time frame: 1 year

  3. Tinetti Fall Risk Scale

    Risk of Falling

    Time frame: 1 year

  4. Spinal Mouse

    Spinal flexibility for balance

    Time frame: 1 year

  5. Walk a Line Battery

    Gait

    Time frame: 1 year

06

Study locations

2 sites
  • Ahi Evran University
    Kırşehir, Kirşehi̇r, Turkey
  • Ahi Evran University
    Kırşehir, Turkey
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03476408
Lead sponsor
Hacettepe University
Responsible party
Caner Karartı (Principal Investigator, Hacettepe University) — Principal investigator
First posted
Mar 26, 2018
Start date
Apr 20, 2017
Primary completion
Mar 15, 2018
Completion
Mar 15, 2018
Last update
Mar 26, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion