NCT06059482

Brief Summary

The study aims to examine whether trunk control affects sitting balance and upper extremity functions in patients with subacute stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2023

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

July 5, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2024

Completed
Last Updated

March 18, 2024

Status Verified

June 1, 2023

Enrollment Period

8 months

First QC Date

July 11, 2023

Last Update Submit

March 15, 2024

Conditions

Keywords

upper extremitystroketrunk controlsitting balance

Outcome Measures

Primary Outcomes (2)

  • Trunk Impairment Scale

    It is a scale developed for the evaluation of the trunk after stroke. It consists of 3 parts:static sitting balance, dynamic sitting balance and coordination. A maximum of 23 points can be obtained, 3 from the static section, 10 from the dynamic section, and 4 from the coordination section. Except for the coordination part, each part is evaluated bilaterally.

    Baseline (First assessment)

  • Trunk Control Test

    Trunk Control Test is a test developed to evaluate trunk control. It consists of 4 parts. The test consists of the parameters of turning from the supine position to the weak and strong side, coming from the supine position to the sitting position and maintaining the sitting balance. The scoring of each section is 0-12-25. The total score is between 0-100. Higher scores indicate better trunk control of the patient.

    Baseline (First assessment)

Secondary Outcomes (2)

  • Fugl-Meyer Assessment

    Baseline (First assessment)

  • Function in Sitting Test (FIST)

    Baseline (First assessment)

Interventions

Evaluations will be made once.

Eligibility Criteria

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

Patients with stroke

You may qualify if:

  • Being diagnosed with stroke and being in the subacute period (stroke onset time is between 0-6 months),
  • Over 18 years old,
  • Mini-Mental Test score ≥ 24 points,
  • Able to sit independently in a chair for 10 minutes
  • To be able to understand and follow simple explanations.

You may not qualify if:

  • Having been diagnosed with a brain stem or cerebellar stroke,
  • Having neurological or orthopedic pathology,
  • Having acute low back pain,
  • Having undergone surgery in the last 6 months,
  • Having neglect, aphasia and heminanopsis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Sciences University

Kütahya, Merkez, 43100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Lütfiye AKKURT, PhD

    Kutahya Health Sciences University

    STUDY DIRECTOR
  • Güllü A YAGCIOĞLU, PhD

    Saglik Bilimleri Universitesi

    STUDY CHAIR
  • Cihan Caner AKSOY, PhD

    Kutahya Health Sciences University

    STUDY CHAIR
  • Fatıma YAMAN, MD

    Kutahya Health Sciences University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2023

First Posted

September 28, 2023

Study Start

July 5, 2023

Primary Completion

March 7, 2024

Study Completion

March 8, 2024

Last Updated

March 18, 2024

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations