NCT05263063

Brief Summary

The aim of the study is to examine the reliability and validity of the synchronous and asynchronous application of Berg Balance Scale and Tinetti Balance Test 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 Jun 2022

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 21, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

June 28, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2023

Completed
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

10 months

First QC Date

February 21, 2022

Last Update Submit

September 14, 2023

Conditions

Keywords

StrokeBalanceSynchronous tele-assessmentAsynchronous tele-assessment

Outcome Measures

Primary Outcomes (1)

  • Berg Balance Scale

    Berg balance scale is a 14-item scale that evaluates the tasks frequently used in daily living activities. Standing without sitting, sitting without support, standing without support, sitting standing, transfers, standing with eyes closed, standing with legs together, reaching forward while standing, picking up objects from the ground, looking back from both sides, turning 360 degrees, stepping alternately It includes functions such as picking up, standing with one foot forward and standing on one foot. Each item is scored between 0-4; 0 indicates that the individual could not fulfill the task, and 4 indicates that he was successful in the task. The total score of the test is between 0-56. 0-20 points: wheelchair dependent, 21-40: assisted walking, 41-56: independent ambulation

    15 minutes

Secondary Outcomes (4)

  • Tinetti Balance Scale

    10 minutes

  • Foot Pressure Distribution and Postural Oscillations

    5 minutes

  • Stroke Rehabilitation Assessment of Movement Scale

    10 minutes

  • Modified Ashworth Scale

    5 minutes

Interventions

On the first day, information about the patient and the disease, filling in the patient data form and face-to-face evaluation will be made face to face with the patients. The next day, one of the synchronous and asynchronous tele-evaluation methods will be applied. Face-to-face interview and face-to-face evaluation will be made by the first physiotherapist in a clinical setting. The synchronous tele-assessment will be evaluated online in real time by the second physiotherapist. For asynchronous tele-assessment, a reference evaluation video will be sent to the patients. Relatives of the patients will be asked to watch this video, make the evaluation and take a video recording at the same time. Then, these video recordings will be evaluated separately by the first and second physiotherapists and the results will be compared. Each assessment will take approximately 30 minutes.

Eligibility Criteria

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

The stroke patients to be included in the study will be selected from among the stroke individuals who applied to Hacettepe University, Faculty of Physical Therapy and Rehabilitation for routine physiotherapy and rehabilitation practices, and those who were eligible according to the inclusion and exclusion criteria and agreed to participate in the study by signing their consent forms.

You may qualify if:

  • have been diagnosed with stroke,
  • aged 18 and over,
  • literate,
  • stroke caused by anterior circulation,
  • computer, phone and tablet etc. Having experience in the use of technological devices and experienced caregivers in this regard,
  • at least Stage 3 in the lower extremities according to Brunnstrom Recovery Stages,
  • A score of 24 and above in the Mini Mental State Test

You may not qualify if:

  • vestibular lesion/dysfunction,
  • auditory and visual lesion/dysfunction,
  • accompanying neurological disorders (Multiple sclerosis, Parkinson, Ataxia, dystonia, dyskinesia, etc.)
  • psychiatric disorders
  • patients with aphasia to a degree that causes communication problems will not be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (1)

  • Onal B, Kose N, Onal SN, Zengin HY. Validity and Reliability of the Berg Balance Scale in Different Tele-Assessment Methods in Patients With Stroke. J Eval Clin Pract. 2025 Jun;31(4):e70141. doi: 10.1111/jep.70141.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Birol Önal

    Hacettepe Univeristy Faculty of Physical Therapy and Rehabilitation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

February 21, 2022

First Posted

March 2, 2022

Study Start

June 28, 2022

Primary Completion

April 28, 2023

Study Completion

August 16, 2023

Last Updated

September 15, 2023

Record last verified: 2023-09

Locations