NCT06010849

Brief Summary

The trunk is the key point of the body. Proximal trunk control is essential for distal extremity movements, balance and functional activities. The aim of the study is to examine the relationship of trunk control with balance, upper extremity and lower extremity functions in stroke patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 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

September 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2022

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2023

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

4 months

First QC Date

August 21, 2023

Last Update Submit

November 22, 2023

Conditions

Keywords

StrokeTrunk ControlBalanceFunction

Outcome Measures

Primary Outcomes (4)

  • The Trunk Impairment Scale

    The Trunk Impairment Scale (TIS) consists of 3 parts: 3 items as static sitting balance, 10 items as dynamic sitting balance, and 4 items as coordination. The maximum points received are 7, 10 and 6 points respectively. The total score of TIS is between 0 and 23. High scores indicate good trunk control (6). Turkish validity and reliability study of TIS was also conducted

    at baseline

  • Berg Balance Scale (BBS)

    BBS: It is the gold standard scale that clinically evaluates balance and postural control. It is a 14-item scale that measures the ability to maintain balance while performing functional tasks. Each item is scored between 0 and 4. If the total score is 56 and above, the balance is considered good.

    at baseline

  • Fugl meyer lower extremity test

    FML: It includes subsections that evaluate hip, knee, ankle joint movements, coordination and reflex activities. The highest score that can be obtained from this assessment is 34.

    at baseline

  • Fugl meyer upper extremity test

    FMU: It includes subsections that evaluate joint movements, coordination and reflex activities related to shoulder, elbow, forearm, wrist and hand. The highest score that can be obtained from this assessment is 66.

    at baseline

Interventions

Trunk controlDIAGNOSTIC_TEST

Trunk control

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Stroke patients

You may qualify if:

  • years old, had an ischemic stroke at least 6 months ago, was at stage 2 according to brunstroma, had a mini-mental test score above 22, could stand independently for 3-4 seconds,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaraş Sütçü Imam University

Kahramanmaraş, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • zekiye ipek katırcı kırmacı

    kahramanmaras sütçü imam university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ass. prof

Study Record Dates

First Submitted

August 21, 2023

First Posted

August 25, 2023

Study Start

September 1, 2021

Primary Completion

December 30, 2021

Study Completion

January 15, 2022

Last Updated

November 28, 2023

Record last verified: 2023-11

Locations