NCT04801927

Brief Summary

The aim of this study is to investigate the validity and reliability of the Turkish version of the Sitting Balance Scale in stroke patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 17, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

9 months

First QC Date

March 13, 2021

Last Update Submit

February 5, 2023

Conditions

Outcome Measures

Primary Outcomes (5)

  • The Sitting Balance Scale

    The Sitting Balance Scale consists of 11 items. Each item is scored between 0 and 4; 0 is worse performance, 4 is best performance. The total score of the test is between 0-44. Higher scores indicate better performance. The scale consists of ''sitting unsupported (eyes open)'', ''sitting unsupported with eyes closed'', ''sitting unsupported with arms as levers'', '' reaching forward with outstretched arm while sitting'', ''pick up an object from the floor while sitting unsupported'', ''placing alternate foot on a Physician's Desk Reference (PDR) while sitting unsupported'', '' reaching laterally with outstretched arm while sitting unsupported'', '' turning to look behind over left and right shoulders while sitting'', '' lateral bend to elbow in sitting'', ''sit to stand transfers'', '' pick up an object from the floor while sitting unsupported on foam''.

    15 minutes

  • Trunk Impairment Scale

    Trunk Impairment Scale was developed to evaluate motor impairments in the trunk after stroke. It consists of three subscales: static sitting balance, dynamic sitting balance, and coordination. Each subscale contains three to ten items. The Trunk Impairment Scale score ranges from a minimum of 0 to a maximum of 23.High scores indicate good balance.

    15 minutes

  • Berg Balance Scale

    Berg Balance Scale is a scale that includes 14 instructions and scores between 0 and 4 by observing the performance of the patient for each instruction. In cases where the patient cannot do the activity at all, 0 points are given, while 4 points are given when the patient completes the activity independently. The highest score is 56, 0-20 points indicate an imbalance, 21-40 points indicate an acceptable balance, 41-56 points indicate the presence of a good balance. Stand unsupported, standing unsupported, sitting unsupported, standing, transfers, standing with feet, standing, standing, standing, picking up, looking back, 360 degrees rotation, hard side stool standing, one foot stand and stand functions are evaluated.

    15 minutes

  • Function in Sitting Test

    The Function in Sitting Test consists of 14 items designed similar to both functional performance and current criteria of balance. The Function Test in Sitting items test various movements, strategies, and simple and complex movement patterns while sitting. Scale, 'front thrust', 'back push', 'side push', 'static sitting', 'nodding as if sitting' no ',' sitting with eyes closed ' , '' lift the foot when sitting '', '' take the back material '', '' reach forward '', '' reach out to the side '', '' pick up the object '', '' move backward '', '' move forward '' Includes "sideways" items. An ordered scale (0-4) is used to score each test item: 0 is fully assisted, 4 completes tasks independently. The total score range of the Function Test in Sitting is 0-56.

    10 minutes

  • Barthel Index

    The Barthel Index consists of 10 items. These items include feeding, washing, self-care, dressing, defecation control, urine control, ability to go to the toilet, ability to move from bed to wheelchair, walking or wheelchair dependency, and climbing stairs. The items are scored over 5-15 points (0-15 points in 5 point increments according to the question). The main purpose of the evaluation made with this scale is to determine to what extent the patient performed these actions independently without any physical or verbal help. The total score is between 0-100: 0-20: fully dependent, 21-61: highly dependent, 62-90: moderately dependent, 91-99: mildly dependent, 100: independent.

    5 minutes

Eligibility Criteria

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

Patients with acute or subacute stroke diagnosed with stroke, aged 18 years or older.

You may qualify if:

  • Being 18 years or older,
  • Diagnosis of stroke,
  • Not having a cooperation and communication problem,
  • At most 6 months have passed after stroke.

You may not qualify if:

  • Other neurological or orthopedic problems that affect functionality and balance other than stroke.
  • Having advanced cardiovascular disease and contraindication for mobilization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kastamonu Training and Research Hospital

Kastamonu, 37150, Turkey (Türkiye)

Location

Related Publications (1)

  • Capraz K, Aydogan Arslan S, Colak T. Investigation of the reliability and validity of the Turkish version of the Sitting Balance Scale in individuals with stroke. Acta Neurol Belg. 2024 Feb;124(1):81-89. doi: 10.1007/s13760-023-02343-6. Epub 2023 Jul 30.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Kübra Çapraz

    Kastamonu Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

March 13, 2021

First Posted

March 17, 2021

Study Start

March 1, 2021

Primary Completion

November 30, 2021

Study Completion

December 30, 2021

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations