NCT04793594

Brief Summary

The aim of this study is to compare the feasibility levels and advantages of balance tests applied with tele-assessment methods to clinical application methods in stroke patients and to reveal their effectiveness.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Status
unknown

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

Study Start

First participant enrolled

March 1, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

March 12, 2021

Status Verified

March 1, 2021

Enrollment Period

3 months

First QC Date

March 8, 2021

Last Update Submit

March 10, 2021

Conditions

Keywords

Tele-assessmentBalanceStroke

Outcome Measures

Primary Outcomes (3)

  • Berg Balance Test

    Berg Balance Test is consisting of 14 items and measures the ability of individuals to maintain balance while performing functional tasks. Each task is scored from 0 (cannot perform independently) to 4 (stated best performance). 0-20 points are interpreted as high risk of falling, between 21-40 points as medium risk of falling, and between 41-56 points as low risk. The validity and reliability study of the Turkish version in stroke patients was performed by Şahin et al.

    12 weeks

  • Tinetti Balance And Gait Scale

    Tinetti Balance And Gait Scale is a total of 28 points, with a maximum of 16 and a walking score of 12 points. Those who score 26 and below are thought to have problems; It is observed that the risk of self-falling is five times higher in those who score 19 and below compared to normal individuals (17). Its adaptation to Turkish, validity and reliability study was carried out by Ağırcan in 2009.

    12 weeks

  • Timed Up And Go Test

    Timed Up And Go Test is a simply and widely used and rapid test for assessing mobility and dinamic balance. The person is asked to stand up from the chair, walk 3 meters safely and at a normal pace, turn around, walk back, sit back on the chair, and the time is recorded in seconds (sec). The test is started with the patient's feet flat on the floor and arms resting on the armrest of the chair, and is performed in three repetitions and the best result is recorded. Walking longer than 12 seconds indicates a risk of falling.

    12 weeks

Study Arms (2)

Tele- Assessment Group

Balance Assessment

Other: Berg Balance TestOther: Tinetti Balance And Gait TestOther: Time Up And Go Test

Face To Face (Clinic) Group

Balance Assessment

Other: Berg Balance TestOther: Tinetti Balance And Gait TestOther: Time Up And Go Test

Interventions

Patients evaluate with Berg Balance Test for balance

Face To Face (Clinic) GroupTele- Assessment Group

Patients evaluate with Tinetti Balance And Gait Test for balance

Face To Face (Clinic) GroupTele- Assessment Group

Patients evaluate with Time Up And Go Test for balance

Face To Face (Clinic) GroupTele- Assessment Group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Stroke is a serious life-threatening medical condition that happens when the blood supply to part of the brain is cut off.

You may qualify if:

  • Sufficient cognitive function for communication (Standardized Mini-Mental Test score\> 24)
  • Not dependent on bed or wheelchair. (1 ≤ Modified Rankin Scale score \<5)
  • Balance problem (Timed Get Up and Go Test score\> 12 sec)
  • Providing the necessary technological competence for remote video communication at home
  • Near a relative who can accompany you during the assessment
  • Age 20-80 years
  • Speaking Turkish

You may not qualify if:

  • Individuals with a neurological and orthopedic disease other than stroke, whose vision and auditory function are affected by stroke, and those with aphasia will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Ceren Bayrak, BSc

    Istanbul University- Cerrahpasa, Faculty of Health Science, Physiotherapy And Rehabilitation Department

    PRINCIPAL INVESTIGATOR
  • Ayse Zengin Alpozgen, PhD

    Istanbul University- Cerrahpasa, Faculty of Health Science, Physiotherapy And Rehabilitation Department

    STUDY CHAIR
  • Yakup Krespi, Professor

    Istinye University, Faculty of Medicine, Neurology Department

    PRINCIPAL INVESTIGATOR
  • Roya Soltanalizadeh, MD

    Istinye University Bahcesehir Liv Hospital

    PRINCIPAL INVESTIGATOR
  • İlknur Mazı, BSc

    Istanbul University- Cerrahpasa, Faculty of Health Science, Physiotherapy And Rehabilitation Department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayse Zengin Alpozgen, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 8, 2021

First Posted

March 11, 2021

Study Start

March 1, 2021

Primary Completion

June 1, 2021

Study Completion

September 1, 2021

Last Updated

March 12, 2021

Record last verified: 2021-03