StrokeNCT05251571
The Efficiency of Video-Based Exercises in Individuals With Stroke
A study testing Conventional Exercise Group with Telerehabilitation and Balance Coordination Group with Telerehabilitation in people with Stroke, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Conventional Exercise Group with Telerehabilitation and Balance Coordination Group with Telerehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Hospital Neurology Polyclinic
Izmir, Bornova, 35030
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Conventional Exercise Group with Telerehabilitation, Balance Coordination Group with Telerehabilitation
- Keywords
- Stroke, Telerehabilitation, Balance, Coordination
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Exercise Group with TelerehabilitationOther
Exercises such as conventional muscle strengthening and stretching given with telerehabilitation are applied.
Balance Coordination Group with TelerehabilitationOther
Functional muscle strengthening, stretching, balance and coordination exercises given with telerehabilitation are applied.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Exercise Group with Telerehabilitation | Active comparator | 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. Receives: Other: Conventional Exercise Group with Telerehabilitation |
| Balance Coordination Group with Telerehabilitation | Experimental | 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. Receives: Other: Balance Coordination Group with Telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline FES-I at 6 weeks
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.
Measured: Change from Baseline ABC at 6 weeks
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.
Measured: Change from Baseline SSEQ at 6 weeks
Secondary outcomes (1)
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.
Measured: Change from Baseline TSQ at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start1 Aug 2022
- Primary completion1 Feb 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Controlled Trial
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Ozden, Muğla Sıtkı Koçman University
- Investigators
- Mehmet Özkeskin, PhD, Principal investigator, Ege Universityİsmet Tümtürk, MSc, Principal investigator, Ege UniversityBedriye Karaman, MD, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251571
- Sponsor's protocol ID
- EGE2
- Status last verified
- Apr 2023
- First submitted
- 31 Jan 2022
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Video-Based Balance and Coordination Exercises in Individuals With Stroke
- ClinicalTrials.gov ID
- NCT05251571
- Acronym / sponsor ID
- EGE2
- Conditions
- Stroke
- Keywords
- Stroke, Telerehabilitation, Balance, Coordination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Conventional Exercise Group with Telerehabilitation | Active comparator | Other: Conventional Exercise Group with TelerehabilitationExercises 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. |
| Balance Coordination Group with Telerehabilitation | Experimental | Other: Balance Coordination Group with TelerehabilitationSit 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. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Exercise Group with TelerehabilitationExercises such as conventional muscle strengthening and stretching given with telerehabilitation are applied. | Other | Conventional Exercise Group with Telerehabilitation |
| Balance Coordination Group with TelerehabilitationFunctional muscle strengthening, stretching, balance and coordination exercises given with telerehabilitation are applied. | Other | Balance Coordination Group with Telerehabilitation |
Primary outcome
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.
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.
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.
1 secondary outcome
TSQ
Time frame: Change from Baseline TSQ at 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet Özkeskin, PhD principal investigator
Ege University
İsmet Tümtürk, MSc principal investigator
Ege University
Bedriye Karaman, MD principal investigator
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Exercise Group with Telerehabilitation and Balance Coordination Group with Telerehabilitation in people with Stroke, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FES-I (time frame: Change from Baseline FES-I at 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.