NCT04752878

Brief Summary

The aim of the study is to describe the cultural adaptation of the Ottawa Sitting Scale and to examine the factor structure, reliability and validity of the scale in patients with stroke. The scale will be translated into Turkish language by following the procedure. 80 patients will be recruited in the study. Berg Balance Scale and Trunk Impairment Scale will be included with Turkish Ottawa Sitting Scale to test the validity. Outcome measures will be repeated by a second physiotherapist the day after the first assessment for interrater reliability and conducted twice within 2 weeks (test-retest) for reliability. The interrater and intrarater reliability of the Ottawa sitting scale will be determined using intraclass correlation coefficients and internal consistency will be assessed using Cronbach's alpha.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

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

February 5, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 12, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

May 15, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
Last Updated

December 27, 2022

Status Verified

December 1, 2022

Enrollment Period

1.1 years

First QC Date

February 5, 2021

Last Update Submit

December 23, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Ottawa sitting scale

    A balance measurement scale for acute stroke patients. The scale tests the patient on a total of 10 items while sitting, with 5 items with eyes open and 5 items with eyes closed. An ordered scale (0-4) is used to score each item. The total score range of the scale is 0-40. Higher scores indicate a better outcome

    Measurements will start with the first patient hospitalized (estimated in March 2021) and end with the evaluation of the 80th patient (estimated period of 12 months)

Secondary Outcomes (2)

  • Berg balance scale

    Measurements will start with the first patient hospitalized (estimated in March 2021) and end with the evaluation of the 80th patient (estimated period of 12 months)

  • Trunk Impairment scale

    Measurements will start with the first patient hospitalized (estimated in March 2021) and end with the evaluation of the 80th patient (estimated period of 12 months)

Interventions

Ottawa sitting scaleDIAGNOSTIC_TEST

The Ottawa Sitting Scale is a performance-based balance measurement consisting of 10 items that aims to evaluate the sitting balance in a comprehensive, specific, efficient and functional manner.

Eligibility Criteria

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

Patients over 18 years of age diagnosed with acute ischemic or hemorrhagic stroke

You may qualify if:

  • Diagnosed with acute stroke
  • aged above 18 years

You may not qualify if:

  • Patients who do not cooperate enough to read or approve the consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sağlık Bilimleri Üniversitesi

Ankara, 06310, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

February 5, 2021

First Posted

February 12, 2021

Study Start

May 15, 2021

Primary Completion

June 15, 2022

Study Completion

September 15, 2022

Last Updated

December 27, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations