- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05251571
The Efficiency of Video-Based Exercises in Individuals With Stroke
April 1, 2023 updated by: Fatih Ozden, Muğla Sıtkı Koçman University
Efficacy of Video-Based Balance and Coordination Exercises in Individuals With Stroke
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bornova
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İzmir, Bornova, Turkey, 35030
- Ege University Hospital Neurology Polyclinic
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Conventional Exercise Group with Telerehabilitation
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.
|
Exercises such as conventional muscle strengthening and stretching given with telerehabilitation are applied.
|
|
Experimental: Balance Coordination Group with Telerehabilitation
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.
|
Functional muscle strengthening, stretching, balance and coordination exercises given with telerehabilitation are applied.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
FES-I
Time Frame: Change from Baseline FES-I at 6 weeks
|
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.
|
Change from Baseline FES-I at 6 weeks
|
|
ABC
Time Frame: Change from Baseline ABC at 6 weeks
|
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.
|
Change from Baseline ABC at 6 weeks
|
|
SSEQ
Time Frame: Change from Baseline SSEQ at 6 weeks
|
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.
|
Change from Baseline SSEQ at 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
TSQ
Time Frame: Change from Baseline TSQ at 6 weeks
|
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.
|
Change from Baseline TSQ at 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bedriye Karaman, MD, Ege University
- Principal Investigator: İsmet Tümtürk, MSc, Ege University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2022
Primary Completion (Actual)
February 1, 2023
Study Completion (Actual)
April 1, 2023
Study Registration Dates
First Submitted
January 31, 2022
First Submitted That Met QC Criteria
February 13, 2022
First Posted (Actual)
February 22, 2022
Study Record Updates
Last Update Posted (Actual)
April 4, 2023
Last Update Submitted That Met QC Criteria
April 1, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EGE2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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