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The Effect of Home-Based Telerehabilitation in Individuals With Stroke

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Home-based Telerehabilitation
Exercise Brochure
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Telerehabilitation, Home-based, Physiotherapy

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with stroke at least 1 year ago by a neurologist
  • Modified Rankin score ≤3
  • Have an internet infrastructure that can be accessed at home
  • Not participated in a standardized physiotherapy program in the past 3 months

Exclusion Criteria:

  • Presence of blurred or low vision problems
  • Hearing and speech impairment at a level that will affect participation in the system
  • Epilepsy
  • Presence of pregnancy
  • Having any cognitive problems that prevent using the system

Sites / Locations

  • Istanbul University-CerrahpasaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Telerehabilitation Group

Control Group

Arm Description

This group will perform their exercises with pre-prepared personalized exercise videos over the telerehabilitation system 3 times a week for 8 weeks.

This group will perform exercises with personalized exercise brochures defined over the telerehabilitation system 3 times a week for 8 weeks.

Outcomes

Primary Outcome Measures

Single Leg Stance Test (The change between the initial value and the value after 2 months will be evaluated)
It is a functional assessment test that measures the patient's standing balance on one leg. It is applied for both legs of the patient with eyes open and closed.
Five Times Sit to Stand Test (The change between the initial value and the value after 2 months will be evaluated)
This test assesses functional lower extremity strength, transfer, balance, and fall risk. The time the patient sits and stands up from the chair 5 times is recorded.
Romberg Test (The change between the initial value and the value after 2 months will be evaluated)
The patient's standing time is recorded in an upright position with her feet open at shoulder level and arms free at the side of the body, with her eyes open and then closed, without losing her balance.
Independent Standing test (The change between the initial value and the value after 2 months will be evaluated)
It tests the patient's ability to stand in an upright position without any support or assistance, with her feet shoulder-width apart and arms free at the side of the body.
Katz Index of Independence in Activities of Daily Living (The change between the initial value and the value after 2 months will be evaluated)
It is a scale that measures the patient's ability to perform activities of daily living independently and evaluates the functional status.

Secondary Outcome Measures

Modified Falls Efficacy Scale (The change between the initial value and the value after 2 months will be evaluated)
It is a 14-item scale that measures the patient's confidence in falling.
WHOQOL-BREF-TR (The change between the initial value and the value after 2 months will be evaluated)
It is a health-related quality of life scale developed by the World Health Organization. A national question was added to the Turkish version of the scale in addition to the original version.
Fatigue Severity Scale (The change between the initial value and the value after 2 months will be evaluated)
It is a scale that evaluates the severity of fatigue with 9 items that patients can answer on their own.
Global Rating of Change Scales
It is a scale that evaluates how much the patient's current condition has changed compared to previous condition.
System Usability Scale
It is a scale consisting of 10 questions widely used in the literature to evaluate the perceptibility and usability of interactive systems.

Full Information

First Posted
October 8, 2021
Last Updated
October 8, 2021
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05083195
Brief Title
The Effect of Home-Based Telerehabilitation in Individuals With Stroke
Official Title
The Effect of Individualized Home-Based Telerehabilitation Intervention on Physical Parameters and Activities of Daily Living in Individuals With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 4, 2021 (Actual)
Primary Completion Date
August 4, 2022 (Anticipated)
Study Completion Date
December 28, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Stroke is a clinical picture that develops due to occlusion or rupture of cerebral vessels and results in loss of cerebral functions. Stroke individuals face some limitations in managing daily activities such as walking, dressing, feeding and showering. Personal, environmental, and societal limitations have led to the development of new treatment strategies, such as telerehabilitation(TR), to meet the needs of stroke individuals and their caregivers. In this study, patients will be randomized and divided into 2 groups in order to examine the effects of two different TR methods on physical parameters and activities of daily living in stroke patients. Baseline assessments will be made for both groups to determine functionality, activities of daily living, fall activity, quality of life, and level of fatigue. For 8 weeks, the TR group will do their exercises with exercise videos prepared on the system 3 times a week. The control group, on the other hand, will do their exercises with exercise brochures on the system 3 times a week for 8 weeks. After 8 weeks, assessments will be repeated. With telerehabilitation to be applied to individuals with stroke, it is aimed to increase functional capacity, independence in daily living activities and quality of life, and reduce the number of falls and fatigue levels.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Telerehabilitation, Home-based, Physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation Group
Arm Type
Experimental
Arm Description
This group will perform their exercises with pre-prepared personalized exercise videos over the telerehabilitation system 3 times a week for 8 weeks.
Arm Title
Control Group
Arm Type
Experimental
Arm Description
This group will perform exercises with personalized exercise brochures defined over the telerehabilitation system 3 times a week for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Home-based Telerehabilitation
Intervention Description
Balance, walking, strengthening exercise videos etc. taken in different positions will be uploaded to the telerehabilitation system. A personalized exercise program will be created from these exercises. This program will be defined to the account of the patient and the follow-up of the person will be carried out through the system.
Intervention Type
Other
Intervention Name(s)
Exercise Brochure
Intervention Description
Photos and explanations of exercises taken in different positions such as balance, walking, strengthening etc. will be uploaded to the telerehabilitation system. A personalized exercise brochure will be created from these exercises. This program will be defined for the patient's account and the patient will be asked to follow the exercises with this brochure.
Primary Outcome Measure Information:
Title
Single Leg Stance Test (The change between the initial value and the value after 2 months will be evaluated)
Description
It is a functional assessment test that measures the patient's standing balance on one leg. It is applied for both legs of the patient with eyes open and closed.
Time Frame
Baseline and end of weeks 8
Title
Five Times Sit to Stand Test (The change between the initial value and the value after 2 months will be evaluated)
Description
This test assesses functional lower extremity strength, transfer, balance, and fall risk. The time the patient sits and stands up from the chair 5 times is recorded.
Time Frame
Baseline and end of weeks 8
Title
Romberg Test (The change between the initial value and the value after 2 months will be evaluated)
Description
The patient's standing time is recorded in an upright position with her feet open at shoulder level and arms free at the side of the body, with her eyes open and then closed, without losing her balance.
Time Frame
Baseline and end of weeks 8
Title
Independent Standing test (The change between the initial value and the value after 2 months will be evaluated)
Description
It tests the patient's ability to stand in an upright position without any support or assistance, with her feet shoulder-width apart and arms free at the side of the body.
Time Frame
Baseline and end of weeks 8
Title
Katz Index of Independence in Activities of Daily Living (The change between the initial value and the value after 2 months will be evaluated)
Description
It is a scale that measures the patient's ability to perform activities of daily living independently and evaluates the functional status.
Time Frame
Baseline and end of weeks 8
Secondary Outcome Measure Information:
Title
Modified Falls Efficacy Scale (The change between the initial value and the value after 2 months will be evaluated)
Description
It is a 14-item scale that measures the patient's confidence in falling.
Time Frame
Baseline and end of weeks 8
Title
WHOQOL-BREF-TR (The change between the initial value and the value after 2 months will be evaluated)
Description
It is a health-related quality of life scale developed by the World Health Organization. A national question was added to the Turkish version of the scale in addition to the original version.
Time Frame
Baseline and end of weeks 8
Title
Fatigue Severity Scale (The change between the initial value and the value after 2 months will be evaluated)
Description
It is a scale that evaluates the severity of fatigue with 9 items that patients can answer on their own.
Time Frame
Baseline and end of weeks 8
Title
Global Rating of Change Scales
Description
It is a scale that evaluates how much the patient's current condition has changed compared to previous condition.
Time Frame
End of weeks 8
Title
System Usability Scale
Description
It is a scale consisting of 10 questions widely used in the literature to evaluate the perceptibility and usability of interactive systems.
Time Frame
End of weeks 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with stroke at least 1 year ago by a neurologist Modified Rankin score ≤3 Have an internet infrastructure that can be accessed at home Not participated in a standardized physiotherapy program in the past 3 months Exclusion Criteria: Presence of blurred or low vision problems Hearing and speech impairment at a level that will affect participation in the system Epilepsy Presence of pregnancy Having any cognitive problems that prevent using the system
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Recep Ormen, M.Sc
Phone
+905316777334
Email
rormen@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Recep Ormen, M.Sc
Organizational Affiliation
Istanbul University-Cerrahpasa Institute of Postgraduate Education
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yonca Zenginler Yazgan, PhD
Organizational Affiliation
Istanbul University-Cerrahpasa Faculty of Health Science
Official's Role
Study Chair
Facility Information:
Facility Name
Istanbul University-Cerrahpasa
City
Istanbul
State/Province
Bakirkoy
ZIP/Postal Code
34100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Recep Ormen, M.Sc
Phone
+905316777334
Email
rormen@gmail.com
First Name & Middle Initial & Last Name & Degree
Yonca Zenginler Yazgan, PhD

12. IPD Sharing Statement

Learn more about this trial

The Effect of Home-Based Telerehabilitation in Individuals With Stroke

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