Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05434052
Other study ID # CIQ-R
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 3, 2022
Est. completion date September 5, 2023

Study information

Verified date October 2023
Source Istanbul Medeniyet University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The aim of this study is to adapt the Community Integration Questionnaire-Revised (CIQ-R) scale to Turkish society and to make its validity and reliability in Turkish. The CIQ-R scale developed by Callaway et al assesses home integration, social integration, productivity, and electronic social networking in neurological diseases. It has 18 questions. This study will be conducted with stroke patients. The patients will be sought to answer questionnaires during regular rehabilitation sessions. 130 participants will be included in the study. In order to evaluate the validity of the CIQ-R, the Mini Mental State Examination (MMSE), which can evaluates general cognitive functioning and has been validated in Turkish, will be used. Scales will be repeated after 15 days to assess test-retest reliability.


Description:

The reliability and validity of the scale will begin with language equivalence and cultural adaptation. The scale will be translated from English to Turkish by two people who are fluent in Turkish and English. A single Turkish translation will be obtained from these two Turkish translations with a common opinion. The scale, which has been translated into Turkish, will be translated into English by two other people who are fluent in Turkish and English. The scale translated into English will be compared with the original. If the developer of the scale, Callaway and Willer approves the translation of the scale, participants will be recruited for the study. In the pre-trial phase, a reassessment will be conducted with 15 participants to test the intelligibility of the scale. Based on the results of the pre-test phase, the final version of CIQ-R will be able to be modified. The data of CIQ-R are collecting through face-to-face when the patients came to the rehabilitation center. 145 participants will be included in the study. In order to evaluate the validity of the CIQ-R, the Mini Mental State Examination (MMSE), which can evaluates general cognitive functioning and has been validated in Turkish, will be used. Scales will be repeated after 15 days to assess test-retest reliability.


Recruitment information / eligibility

Status Completed
Enrollment 130
Est. completion date September 5, 2023
Est. primary completion date August 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: Patients with - duration of hemiplegia = 3 year - able to speak and read Turkish - those with a Mini Mental State Examination score of 24 and above Exclusion Criteria: Patients with - communication or cognitive problems, - aphasia and speech disorders - unstable medical conditions

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Turkish Validity and Reliability of The CIQ-R Scale
The aim of this study is to adapt the Community Integration Questionnaire-Revised (CIQ-R)scale to Turkish society and to make its validity and reliability in Turkish. It has 18 questions. This study will be conducted with stroke patients. The patients will be sought to answer questionnaires during regular rehabilitation sessions.

Locations

Country Name City State
Turkey Emel Mete Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary community integration community integration will be assessed with the Community Integration Questionnaire-Revised (CIQ-R) scale. It consists of 18 items in total. Each item is scored on a scale of 0-2 includes four sub-categories: Home Integration (HI), Social Integration (SI), Productivity (P), and Electronic Social Network (ESN).
The total score is the calculated sum of 18 items. The minimum score is 0 and the maximum score is 35 points. Higher scores indicate a high level of community integration which means better community integration.
baseline
Primary Cognitive function The Mini-Mental State Examination (MMSE), which is a widely used cognitive assessment questionnaire is quite short. It evaluates general cognitive functioning (especially in the left cerebral hemisphere) and ranged from 0 to 30 points. According to the scale results; It is accepted that there is severe cognitive influence between 0-17 points, moderate cognitive influence between 18-23 points, and no cognitive influence between 24-30 points. Higher scores mean better cognitive function. baseline
See also
  Status Clinical Trial Phase
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04034069 - Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial N/A
Suspended NCT03869138 - Alternative Therapies for Improving Physical Function in Individuals With Stroke N/A
Completed NCT04101695 - Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects N/A
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Completed NCT00391378 - Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS) N/A
Recruiting NCT06204744 - Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial N/A
Active, not recruiting NCT06043167 - Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
Enrolling by invitation NCT04535479 - Dry Needling for Spasticity in Stroke N/A
Completed NCT03985761 - Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke N/A
Recruiting NCT00859885 - International PFO Consortium N/A
Recruiting NCT06034119 - Effects of Voluntary Adjustments During Walking in Participants Post-stroke N/A
Completed NCT03622411 - Tablet-based Aphasia Therapy in the Chronic Phase N/A
Completed NCT01662960 - Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke N/A
Recruiting NCT05854485 - Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke N/A
Active, not recruiting NCT05520528 - Impact of Group Participation on Adults With Aphasia N/A
Active, not recruiting NCT03366129 - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Completed NCT05805748 - Serious Game Therapy in Neglect Patients N/A
Completed NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Recruiting NCT05621980 - Finger Movement Training After Stroke N/A