Back to resultsThe Efficiency of Video-Based Exercises in Individuals With Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Conventional Exercise Group with Telerehabilitation
Balance Coordination Group with Telerehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, Telerehabilitation, Balance, Coordination
Eligibility Criteria
Inclusion Criteria:
- Male and female patients aged 40 - 65 years
- Having been diagnosed with stroke by a specialist physician and at least 3 months and maximum 6 months have passed since the diagnosis
- No serious medical complications
- Being able to understand verbal and visual commands
- Getting at least 24 points on the mini mental state test
- Able to walk at least 10 m without assistance using crutches or a walker
- Having signed the consent form
Exclusion Criteria:
- Situations that will prevent assessments or communication with the individual
- Being on psychotropic medication
- People with ataxia or any other cerebellar symptoms
- Other problems that would preclude evaluation and/or treatment
Sites / Locations
- Ege University Hospital Neurology Polyclinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional Exercise Group with Telerehabilitation
Balance Coordination Group with Telerehabilitation
Arm Description
Exercises such as muscle strengthening exercises applied to antigravity muscles, agonist antagonist spastic muscles, stretching exercises for spastic muscles, weight transfer will be applied, and a telerehabilitation platform will be used in the home exercise program.
Sit and stand exercise from chair, standing posture, weight transfer to right and left extremities, stepping over obstacles, standing on one leg with support from the table, standing on two legs with support from the table, hip abduction with support from the table, extension, flexion, supported tandem walking exercises such as stepping on the stairs, standing functional stretches will be applied. Whatsapp application-based Telerehabilitation platform will be used to deliver the home exercise program.
Outcomes
Primary Outcome Measures
FES-I
There are 16 items in FES-I that assess the fear of falling during daily activities. FES-I is scored from 0 to 64. Higher scores indicate higher concerns about falling.
ABC
This scale includes 16 tasks related to indoor and outdoor activities of daily living to measure balance confidence in the elderly with various levels of function. Higher scores indicate more confidence. ABC is scored from 0 to 100. Higher scores indicate higher function.
SSEQ
The 13-item SSEQ is used to measure participants' self-efficacy levels in performing daily functional activities and self-management. SSEQ is scored from 0 to 130. Higher scores indicate higher confidence.
Secondary Outcome Measures
TSQ
This questionnaire consists of 14 items. The level of satisfaction of the patients with the software or system from which they receive treatment or other remote rehabilitation services is evaluated. TSQ is scored from 14 to 170. Higher scores indicate higher satisfaction.
Full Information
NCT ID
NCT05251571
First Posted
January 31, 2022
Last Updated
April 1, 2023
Sponsor
Muğla Sıtkı Koçman University
1. Study Identification
Unique Protocol Identification Number
NCT05251571
Brief Title
The Efficiency of Video-Based Exercises in Individuals With Stroke
Official Title
Efficacy of Video-Based Balance and Coordination Exercises in Individuals With Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
April 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Muğla Sıtkı Koçman University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to compare the video-based balance coordination exercise program and the video-based conventional exercise program in patients with subacute stroke.
Detailed Description
Thanks to telerehabilitation, it will be possible for individuals to learn the exercise programs in the most appropriate way and to communicate easily with their physiotherapists with video images. In this way, it will be ensured that individuals can perform their exercises at the optimum level in non-clinical environments. The aim of the study is to compare the conventional home exercise program performed with video-based telerehabilitation and the balance coordination program in subacute stroke patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Telerehabilitation, Balance, Coordination
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised Controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional Exercise Group with Telerehabilitation
Arm Type
Active Comparator
Arm Description
Exercises such as muscle strengthening exercises applied to antigravity muscles, agonist antagonist spastic muscles, stretching exercises for spastic muscles, weight transfer will be applied, and a telerehabilitation platform will be used in the home exercise program.
Arm Title
Balance Coordination Group with Telerehabilitation
Arm Type
Experimental
Arm Description
Sit and stand exercise from chair, standing posture, weight transfer to right and left extremities, stepping over obstacles, standing on one leg with support from the table, standing on two legs with support from the table, hip abduction with support from the table, extension, flexion, supported tandem walking exercises such as stepping on the stairs, standing functional stretches will be applied. Whatsapp application-based Telerehabilitation platform will be used to deliver the home exercise program.
Intervention Type
Other
Intervention Name(s)
Conventional Exercise Group with Telerehabilitation
Intervention Description
Exercises such as conventional muscle strengthening and stretching given with telerehabilitation are applied.
Intervention Type
Other
Intervention Name(s)
Balance Coordination Group with Telerehabilitation
Intervention Description
Functional muscle strengthening, stretching, balance and coordination exercises given with telerehabilitation are applied.
Primary Outcome Measure Information:
Title
FES-I
Description
There are 16 items in FES-I that assess the fear of falling during daily activities. FES-I is scored from 0 to 64. Higher scores indicate higher concerns about falling.
Time Frame
Change from Baseline FES-I at 6 weeks
Title
ABC
Description
This scale includes 16 tasks related to indoor and outdoor activities of daily living to measure balance confidence in the elderly with various levels of function. Higher scores indicate more confidence. ABC is scored from 0 to 100. Higher scores indicate higher function.
Time Frame
Change from Baseline ABC at 6 weeks
Title
SSEQ
Description
The 13-item SSEQ is used to measure participants' self-efficacy levels in performing daily functional activities and self-management. SSEQ is scored from 0 to 130. Higher scores indicate higher confidence.
Time Frame
Change from Baseline SSEQ at 6 weeks
Secondary Outcome Measure Information:
Title
TSQ
Description
This questionnaire consists of 14 items. The level of satisfaction of the patients with the software or system from which they receive treatment or other remote rehabilitation services is evaluated. TSQ is scored from 14 to 170. Higher scores indicate higher satisfaction.
Time Frame
Change from Baseline TSQ at 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female patients aged 40 - 65 years
Having been diagnosed with stroke by a specialist physician and at least 3 months and maximum 6 months have passed since the diagnosis
No serious medical complications
Being able to understand verbal and visual commands
Getting at least 24 points on the mini mental state test
Able to walk at least 10 m without assistance using crutches or a walker
Having signed the consent form
Exclusion Criteria:
Situations that will prevent assessments or communication with the individual
Being on psychotropic medication
People with ataxia or any other cerebellar symptoms
Other problems that would preclude evaluation and/or treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet Özkeskin, PhD
Organizational Affiliation
Ege University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
İsmet Tümtürk, MSc
Organizational Affiliation
Ege University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bedriye Karaman, MD
Organizational Affiliation
Ege University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ege University Hospital Neurology Polyclinic
City
İzmir
State/Province
Bornova
ZIP/Postal Code
35030
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Efficiency of Video-Based Exercises in Individuals With Stroke
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