StrokeNCT06558721
Effectiveness of Functional Electric Stimulation With Bicycle Ergometer and Mirror Therapy in Stroke Patients Lower Extremity
A study testing Conventional rehabilitation, Mirror therapy and Bicycle ergometer with functional electric stimulation in people with Stroke, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
There are different methods in stroke rehabilitation. In addition to conventional techniques, functional electric stimulation with bicycle ergometer therapy and mirror therapy can be used. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Conventional rehabilitation, Mirror therapy and Bicycle ergometer with functional electric stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 1 Aug 2024
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-85 age
- Unilateral stroke
- First time stroke
- Time after stroke less than 6 months
- Lower extremity Brunnstrom stage: 2-4
- Lower extremity spasticity Modified Ashworth Scale: less than 3
Show all 9Show fewer
- Patient with sitting balance
- Mini Mental Test Score higher than 23
- Patients signed approval form
Who cannot join
- Bilateral stroke
- Neurological disease other than stroke
- Psychiatric disease
- Lower extremity orthopedic problem
- Visual or audience problem
- Neglect
Show all 13Show fewer
- Severe aphasia
- Contraindications of electrical stimulation (cardiac implantation etc.)
- Severe comorbidity (cardiac failure etc.)
- Seizure
- Acute deep vein thromboembolism
- Local infection
- Botulinum toxin injection of lower extremity less than 3 month
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziler Physical Medicine and Rehabilitation Training and Research Hospital
Ankara, Çankaya, 06800
About this study
Official title: Comparison of the Effectiveness of Mirror Therapy and Functional Electrical Stimulation Bicycle Ergometry Therapy Applied to the Lower Extremity in Stroke Patients
There are different methods in stroke rehabilitation. In addition to conventional techniques, functional electric stimulation with bicycle ergometer therapy and mirror therapy can be used. In this study, we will compare functional electric stimulation with bicycle ergometer therapy and mirror therapy in stroke patients.
Read the detailed description
Aim of study is to compare functional electric stimulation with bicycle ergometer therapy and mirror therapy applied to lower extremity in stroke patients.
- Conditions
- Stroke
- Being tested
- Conventional rehabilitation, Mirror therapy, Bicycle ergometer with functional electric stimulation
- Keywords
- Stroke, Lower Extremity, Mirror Therapy, Functional Electric Stimulation, Bicycle Ergometer
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional rehabilitationOther
Lower extremity conventional rehabilitation in stroke patients
Mirror therapyOther
Mirror therapy of the lower extremity in stroke patients
Bicycle ergometer with functional electric stimulationDevice
Bicycle ergometer with functional electric stimulation therapy of the lower extremity in stroke patients
| Study group | Role | What they receive |
|---|---|---|
| Conventional Rehabilitation | Active comparator | Lower extremity conventional rehabilitation in stroke patients Receives: Other: Conventional rehabilitation |
| Conventional Rehabilitation + Mirror Therapy | Active comparator | Mirror therapy in addition to conventional rehabilitation of the lower extremity in stroke patients Receives: Other: Conventional rehabilitation; Other: Mirror therapy |
| Conventional Rehabilitation + Bicycle Ergometer with Functional Electric Stimulation | Active comparator | Bicycle Ergometer with Functional Electric Stimulation Therapy in addition to conventional rehabilitation of the lower extremity in stroke patients Receives: Other: Conventional rehabilitation; Device: Bicycle ergometer with functional electric stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl Meyer Lower Extremity Motor Subscale
Measured: Before treatment (0. week), finishing time of treatment (6.week)
Secondary outcomes (5)
Brunnstrom Staging
Measured: Before treatment (0. week), finishing time of treatment (6.week)
Berg Balance Scale
Measured: Before treatment (0. week), finishing time of treatment (6.week)
Functional Independence Measure - Motor Score
Measured: Before treatment (0. week), finishing time of treatment (6.week)
Stroke Specific Quality of Life Scale
Measured: Before treatment (0. week), finishing time of treatment (6.week)
Functional Ambulation Scale
Measured: Before treatment (0. week), finishing time of treatment (6.week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start1 Oct 2023
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Sefa Cınar, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Investigators
- Engin Koyuncu, Prof. Dr., Principal investigator, Gaziler Physical Therapy and Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558721
- Sponsor's protocol ID
- E1-23-4032
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cinar MS, Koyuncu E, Atan T, Gurcay E. Mirror therapy versus functional electrical stimulation cycling in post-stroke lower limb rehabilitation: a randomized controlled trial. Top Stroke Rehabil. 2026 Oct 1:1-11. doi: 10.1080/10749357.2026.2742170. Online ahead of print.
PubMed 42820841
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Mirror Therapy and Functional Electrical Stimulation Bicycle Ergometry Therapy Applied to the Lower Extremity in Stroke Patients
- ClinicalTrials.gov ID
- NCT06558721
- Acronym / sponsor ID
- E1-23-4032
- Conditions
- Stroke
- Keywords
- Stroke, Lower Extremity, Mirror Therapy, Functional Electric Stimulation, Bicycle Ergometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 19 Aug 2024 (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.
There are different methods in stroke rehabilitation. In addition to conventional techniques, functional electric stimulation with bicycle ergometer therapy and mirror therapy can be used. In this study, we will compare functional electric stimulation with bicycle ergometer therapy and mirror therapy in stroke patients.
Detailed description
Aim of study is to compare functional electric stimulation with bicycle ergometer therapy and mirror therapy applied to lower extremity in stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Rehabilitation | Active comparator | Other: Conventional rehabilitationLower extremity conventional rehabilitation in stroke patients |
| Conventional Rehabilitation + Mirror Therapy | Active comparator | Other: Conventional rehabilitation, Other: Mirror therapyMirror therapy in addition to conventional rehabilitation of the lower extremity in stroke patients |
| Conventional Rehabilitation + Bicycle Ergometer with Functional Electric Stimulation | Active comparator | Other: Conventional rehabilitation, Device: Bicycle ergometer with functional electric stimulationBicycle Ergometer with Functional Electric Stimulation Therapy in addition to conventional rehabilitation of the lower extremity in stroke patients |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18-85 age
- Unilateral stroke
- First time stroke
- Time after stroke less than 6 months
- Lower extremity Brunnstrom stage: 2-4
Key exclusion criteria (13 listed)
- Bilateral stroke
- Neurological disease other than stroke
- Psychiatric disease
- Lower extremity orthopedic problem
- Visual or audience problem
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 rehabilitationLower extremity conventional rehabilitation in stroke patients | Other | Conventional Rehabilitation, Conventional Rehabilitation + Bicycle Ergometer with Functional Electric Stimulation, Conventional Rehabilitation + Mirror Therapy |
| Mirror therapyMirror therapy of the lower extremity in stroke patients | Other | Conventional Rehabilitation + Mirror Therapy |
| Bicycle ergometer with functional electric stimulationBicycle ergometer with functional electric stimulation therapy of the lower extremity in stroke patients | Device | Conventional Rehabilitation + Bicycle Ergometer with Functional Electric Stimulation |
Primary outcome
Fugl Meyer Lower Extremity Motor Subscale
Time frame: Before treatment (0. week), finishing time of treatment (6.week)
5 secondary outcomes
Brunnstrom Staging
Time frame: Before treatment (0. week), finishing time of treatment (6.week)
Berg Balance Scale
Time frame: Before treatment (0. week), finishing time of treatment (6.week)
Functional Independence Measure - Motor Score
Time frame: Before treatment (0. week), finishing time of treatment (6.week)
Stroke Specific Quality of Life Scale
Time frame: Before treatment (0. week), finishing time of treatment (6.week)
Functional Ambulation Scale
Time frame: Before treatment (0. week), finishing time of treatment (6.week)
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 19 Nov 2025.
- Derived from this study: PubMed 42820841Cinar MS, Koyuncu E, Atan T, Gurcay E. Mirror therapy versus functional electrical stimulation cycling in post-stroke lower limb rehabilitation: a randomized controlled trial. Top Stroke Rehabil. 2026 Oct 1:1-11. doi: 10.1080/10749357.2026.2742170. Online ahead of print.
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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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.
Engin Koyuncu, Prof. Dr. principal investigator
Gaziler Physical Therapy and Rehabilitation Training and Research Hospital
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 rehabilitation, Mirror therapy and Bicycle ergometer with functional electric stimulation in people with Stroke, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital 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 9 inclusion and 13 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 19 Nov 2025. 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?
Fugl Meyer Lower Extremity Motor Subscale (time frame: Before treatment (0. week), finishing time of treatment (6.week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06558721, which also lists 1 linked publication.
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 19 Nov 2025.