NCT07141966

Brief Summary

Schizophrenia is a serious mental health condition that affects individuals' thinking, perception, emotional responses, and behavior. Balance in schizophrenia patients is often related to motor skills, coordination, and postural control. Schizophrenia can cause functional changes in certain areas of the brain. These changes can affect motor functions. Balance loss in schizophrenia patients can cause difficulties in daily living activities, increased risk of falls, and a decrease in overall quality of life. Therefore, the aim of this study is to evaluate physical activity, balance, muscle strength, and cognitive function in patients diagnosed with schizophrenia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

August 19, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 26, 2025

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2025

Completed
Last Updated

August 19, 2026

Status Verified

August 1, 2025

Enrollment Period

11 days

First QC Date

August 19, 2025

Last Update Submit

August 17, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • International Physical Activity Questionnaire (IPAQ):

    Used to assess an individual's physical activity level over the past 7 days. The International Physical Activity Questionnaire (IPAQ) consists of 4 questionnaires. There are long (5 independently asked activity areas) and short (4 general items) versions. The short version consists of questions about the time spent walking and engaging in moderate to vigorous and strenuous activities.

    2 weeks

  • Berg Balance Scale

    Berg Balance Scale The scale, consisting of a total of 14 items, assesses patients' balance skills. Each item is scored on a scale of 0-4. 0 = unable to perform, 4 = normal performance. The maximum score is 56, and a high score indicates better balance skills. The physical therapist administers the test by providing the necessary instructions to the patient in a manner they can understand after the patient has rested. The choice of which foot to use in certain items should be left to the patient. The materials required for the test (stopwatch, measuring tape, chair, step, slippers) should be prepared before beginning the assessment.

    2 weeks

  • Handgrip Strength

    Handgrip strength was assessed using the JTech Commander GripTrack™ hand dynamometer. Participants performed the measurement according to a standardized testing procedure, and grip strength was recorded in kilograms (kg). Higher values indicate greater handgrip strength.

    2 weeks

  • Mini Mental State Examination

    The standardized version of the MMSE (Mini Mental State Examination) developed by Folstein et al. (1975) was adapted by Molloy and Standish (1997). The MMSE allows for cognitive assessment in a short period of time. In this regard, the MMSE is a short, easy-to-administer, and standardized test used to assess global cognitive level. The test is widely used to evaluate the cognitive status of elderly individuals. A validity and reliability study in the Turkish population was conducted by Güngen and colleagues (2002). In their study, Güngen and colleagues (2002) determined that the 23/24 cutoff value of the Standardized Mini Mental Test (SMMT) had a sensitivity of 0.91, a specificity of 0.95, an inter-rater reliability of r:0.99, and a kappa value of 0.92. As a result, it was determined that the Standardized Mini Mental Test is valid and reliable in the Turkish population.

    2 weeks

Study Arms (1)

patients with schizophrenia

patients with schizophrenia

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Schizophrenia

You may qualify if:

  • Diagnosis of schizophrenia by a psychiatrist according to DSM-V
  • aged between 18 and 65 years
  • being clinically stable
  • having received continuous pharmacological treatment for at least six months
  • having the ability to understand and follow verbal and written instructions

You may not qualify if:

  • major neurological disorders (e.g. epilepsy or Parkinson's disease)
  • significant orthopaedic impairments affecting balance or strength
  • substance use disorders (except nicotine)
  • acute psychotic symptoms and severe intellectual disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kartal Dr Lütfi Kırdar City Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Prof

Study Record Dates

First Submitted

August 19, 2025

First Posted

August 26, 2025

Study Start

August 19, 2025

Primary Completion

August 30, 2025

Study Completion

September 15, 2025

Last Updated

August 19, 2026

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations