NCT05544422

Brief Summary

Stroke is the third leading cause of death in the world after coronary heart disease and cancer. In recent years, by controlling the risk factors of stroke, its incidence has decreased by 30% and the mortality rate due to this disease has decreased by 14%. However, it is still among the most important diseases that cause disability in adults. The aging of the world population and the increase in the number of individuals with chronic diseases, including stroke, increase the need for rehabilitation services rapidly. Access to rehabilitation services is restricted due to the insufficient number of specialist health personnel and the difficulty of transportation for people living in rural areas. At the same time, barriers such as decrease in physical mobility, increase in bothersome symptoms and travel restrictions in developed countries are expected to increase with the aging population and will cause a decrease in participation in rehabilitation. In this context, telerehabilitation shows a promising way to increase rehabilitation access with fewer healthcare professionals or to help maintain positive outcomes following rehabilitation. Telerehabilitation, which is among the telehealth possibilities, is defined as the use of information and communication technologies to provide clinical rehabilitation services remotely. These technologies allow communication between healthcare personnel and patients, as well as the transmission of imaging and other healthcare data from one place to another. Telerehabilitation includes clinical rehabilitation services focused on evaluation, diagnosis and treatment (Janet vd.,). Tele-assessment, which is among the service delivery model of telerehabilitation, is defined as the transfer of patient data to the healthcare professional or team, instantly or retrospectively, through equipment, sensors, questionnaires and tests. Unlike other services, there are factors that make tele-assessment difficult. It is necessary to ensure that patient performance is correctly evaluated. Internet and video transmission can affect the ability to accurately assess patient performance and thus affect the tele-assessment. Consideration should be given to the validation of tele-assessment for certain assessments that are frequently used in the assessment of patient performance. For this reason, we chose to examine the timed 'Up \& Go'(TUG) test and '30second Chair-Stand Test' (30s-CST), which are the most common tests in the evaluation of lower extremity muscle strength, balance, and mobility in rehabilitation. TUG and 30s-CST are simple clinical outcome measures commonly used to assess functional performance. Johansen et al. found that the TUG test and 30s-CST in stroke patients had excellent internal and inter-research reliability when administered face-to-face. This study is based on studies showing that the application of tests that are effective in the evaluation of functional performance with the tele-assessment method is an effective method.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

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

August 9, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
29 days until next milestone

Study Start

First participant enrolled

October 15, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
Last Updated

June 4, 2024

Status Verified

June 1, 2024

Enrollment Period

1 month

First QC Date

August 9, 2022

Last Update Submit

June 2, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • The Timed Up & Go Test

    It is a measurement that evaluates functional mobility, dynamic balance, fall risk and postural stability that can be applied for different purposes in different age and patient groups. The activities that make up the test evaluate the transition from sitting to standing position, walking, turning, and sitting again, which are necessary for functional mobility and dynamic balance. The ZQM test measures the time it takes for an individual to get up from a standard chair with armrests and walk a distance of 3 meters, return from a designated or marked place, return to the chair, and sit back down.

    2 week

  • The 30-second Chair Stand Test

    In a chair with a sitting height of 43.2 cm and a back supported, the patient is asked to sit and stand as quickly as possible. The patient sits in the chair. They cross their hands on their chest. Before the test, 2 attempts are made. The number of sitting down times is noted by keeping a 30-second timer with a stopwatch. Less than 10 sit-ups in 30 seconds indicates lower extremity muscle weakness.

    2 week

  • The 6 minute walk test

    The individual is asked to walk on a certain track for 6 minutes. The test is performed in a closed area, on a flat surface of 30 m in length and under the supervision of the evaluator. After six minutes, the total distance walked is recorded in meters.

    2 week

Secondary Outcomes (3)

  • The Tinetti Balance and Gait test

    2 week

  • The Functional Independence Measure

    2 week

  • Mini-Mental State Examination

    2 week

Study Arms (1)

Study Group

OTHER

The Timed Up \& Go Test and 30-second Chair-Stand Tests with conventional and tele-assessment methods will be applied to the participants included in the study.

Other: The Timed Up & Go Test and 30second Chair-Stand Test'

Interventions

Evaluation of the participants will be carried out in the following order; 1) traditional assessment, 2) tele-assessment, 3) post-test. In the final test, only tele-assessment of the tests will be made. During testing sessions, the results of each TUG and 30s-CST trial will be recorded on a standard test paper. TUG and 30s-CST will be tested in two different ways, traditional and tele, as 2 sessions every other day. Participants will rest for five to ten minutes between trials and an hour between sessions. During the one-hour rest between two test sessions, participants will rest in a chair, wheelchair or bed. Assessors will not know the TUG and 30s-CST results scored by each other.

Study Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have had a stroke at least 6 months ago
  • be between the ages of 18-65
  • A Mini Mental Test result of more than 24 points
  • Lower extremity score of 5-6 for Brunnstrom
  • not have cognitive impairment
  • Willingness and volunteering to work
  • Having and being able to use a smart mobile device or a computer with a camera
  • have an internet package

You may not qualify if:

  • Having a different vestibular and orthopedic problem
  • Having a visual or hearing impairment
  • Known cardiopulmonary disease
  • Having had a transient ischemic attack or multiple stroke
  • Lack of independent sitting and standing balance
  • have chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye University

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 9, 2022

First Posted

September 16, 2022

Study Start

October 15, 2022

Primary Completion

November 15, 2022

Study Completion

December 15, 2022

Last Updated

June 4, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations