NCT07652710

Brief Summary

Stroke is one of the leading causes of long-term disability worldwide and is frequently associated with impairments in balance, upper extremity function, and body awareness. These impairments may negatively affect independence in activities of daily living and overall quality of life. Although previous studies have investigated the relationships between balance and upper extremity function after stroke, body awareness has received relatively limited attention. The aim of this observational cross-sectional study is to investigate the relationship between balance, upper extremity skills, and body awareness in individuals with chronic stroke. Fifty-three individuals with chronic stroke will be recruited from the Department of Physical Medicine and Rehabilitation at Baskent University Hospital. Balance will be assessed using the Berg Balance Scale and the Tetrax computerized posturography system. Upper extremity motor impairment and functional performance will be evaluated using the Fugl-Meyer Upper Extremity Assessment and the Wolf Motor Function Test. Body awareness will be assessed using the Body Awareness Questionnaire. Additional assessments will include lower extremity motor function, muscle tone, cognitive status, shoulder range of motion, and upper extremity reaction time. The study is expected to provide a better understanding of the relationships among balance, upper extremity function, and body awareness in individuals with chronic stroke. The findings may contribute to the development of individualized rehabilitation strategies and improve clinical assessment approaches in stroke rehabilitation.

Trial Health

63
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Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
4mo left

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

June 5, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

June 20, 2026

Expected
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2026

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2026

Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

June 5, 2026

Last Update Submit

June 11, 2026

Conditions

Keywords

strokepostural balanceupper extremitybody image

Outcome Measures

Primary Outcomes (9)

  • Berg Balance Scale Score

    To assess balance performance, the Berg Balance Scale (BBS) will be used. The scale consists of 14 functional tasks including sitting to standing, transfers, turning, reaching forward, picking up an object from the floor, and standing on one leg. Each item is scored from 0 to 4. Total scores range from 0 to 56, with higher scores indicating better balance performance.

    Baseline (single assessment)

  • Tetrax Fall Index

    To assess fall risk the Tetrax Computerized Posturography System will be used. Measurements will be performed under eight different sensory conditions. The Fall Index ranges from 0 to 100, with higher scores indicating a greater risk of falling.

    Baseline (single assessment)

  • Eyes Open Stability Index

    To assess postural stability under eyes-open conditions, the Tetrax Computerized Posturography System will be used. The Stability Index obtained during the normal standing position with eyes open will be recorded. Higher values indicate poorer postural stability.

    Baseline (single assessment)

  • Eyes Closed Stability Index

    To assess postural stability without visual input, participants will stand on the Tetrax Computerized Posturography System with their eyes closed. The Stability Index obtained during this condition will be recorded. Higher values indicate poorer postural stability.

    Baseline (single assessment)

  • Weight Distribution Index

    To assess weight distribution during standing, the Tetrax Computerized Posturography System will be used. The Weight Distribution Index will be recorded. Higher values indicate greater asymmetry in weight distribution between the supporting surfaces.

    Baseline (single assessment)

  • Fugl-Meyer Upper Extremity Assessment Score

    To assess upper extremity motor impairment, the Fugl-Meyer Upper Extremity Assessment will be used. The scale evaluates reflex activity, voluntary movement, coordination, and speed. Scores range from 0 to 66, with higher scores indicating better upper extremity motor function.

    Baseline (single assessment)

  • Wolf Motor Function Test Functional Ability Score

    Upper extremity functional ability will be assessed using the Functional Ability Scale of the Wolf Motor Function Test (WMFT). Fifteen functional tasks will be evaluated and scored on a scale from 0 to 5, with higher scores indicating better upper extremity function.

    Baseline (single assessment)

  • Wolf Motor Function Test Performance Time

    Upper extremity motor performance will be assessed using the Wolf Motor Function Test (WMFT). The average time required to complete the 15 functional tasks will be recorded in seconds. Shorter completion times indicate better upper extremity performance.

    Baseline (single assessment)

  • Body Awareness Questionnaire Score

    To assess body awareness, the Body Awareness Questionnaire will be used. The questionnaire consists of 18 items evaluating awareness of bodily processes and reactions. Total scores range from 18 to 126, with higher scores indicating greater body awareness.

    Baseline (single assessment)

Secondary Outcomes (2)

  • Upper Extremity Reaction Time

    Baseline (single assessment)

  • Fugl-Meyer Lower Extremity Assessment Score

    Baseline (single assessment)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals with chronic stroke who are receiving outpatient follow-up and rehabilitation services at the Department of Physical Medicine and Rehabilitation, Baskent University Hospital.

You may qualify if:

  • Individuals who experienced a cerebrovascular event at least 6 months previously
  • Individuals between 18 and 75 years of age
  • Individuals who have experienced stroke for the first time
  • Individuals with shoulder, elbow, wrist, and finger muscle tone graded as 2 or 3 according to the Modified Ashworth Scale (MAS)
  • Individuals scoring 24 points or higher on the Standardized Mini Mental State Examination
  • Individuals with at least 120° of shoulder range of motion
  • Individuals who are able to walk independently or with a walking aid

You may not qualify if:

  • Presence of communication problems such as difficulties in reading, writing, or speaking
  • Botulinum toxin injection within the last 3 months
  • Presence of hemispatial neglect syndrome
  • Presence of ataxia due to posterior circulation ischemia
  • Bilateral involvement (bilateral hemiparesis)
  • Having received physiotherapy within the last 6 months
  • Presence of orthopedic problems such as shoulder subluxation, shoulder pain, contracture of the hand and wrist
  • History of upper extremity or thoracic surgery
  • Presence of stroke-related visual impairments (hemianopia)
  • Presence of color blindness
  • Use of antiepileptic medication
  • History of convulsions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University Hospital

Ankara, Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Zeliha Özlem O YÜRÜK

    Baskent University Hospital, Department of Physical Medicine and Rehabilitation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuğba DÖRTBÖLÜK, BSc

CONTACT

Zeliha Özlem O YÜRÜK

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

June 5, 2026

First Posted

June 17, 2026

Study Start (Estimated)

June 20, 2026

Primary Completion (Estimated)

August 20, 2026

Study Completion (Estimated)

October 20, 2026

Last Updated

June 17, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations