- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06558721
Effectiveness of Functional Electric Stimulation With Bicycle Ergometer and Mirror Therapy in Stroke Patients Lower Extremity
November 17, 2025 updated by: Muhammed Sefa Cınar, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
45
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
-
-
Çankaya
-
Ankara, Çankaya, Turkey (Türkiye), 06800
- Gaziler Physical Medicine and Rehabilitation Training and Research Hospital
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
- Patient with sitting balance
- Mini Mental Test Score higher than 23
- Patients signed approval form
Exclusion Criteria:
- Bilateral stroke
- Neurological disease other than stroke
- Psychiatric disease
- Lower extremity orthopedic problem
- Visual or audience problem
- Neglect
- 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
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 Rehabilitation
Lower extremity conventional rehabilitation in stroke patients
|
Lower extremity conventional rehabilitation in stroke patients
|
|
Active Comparator: Conventional Rehabilitation + Mirror Therapy
Mirror therapy in addition to conventional rehabilitation of the lower extremity in stroke patients
|
Lower extremity conventional rehabilitation in stroke patients
Mirror therapy of the lower extremity in stroke patients
|
|
Active Comparator: Conventional Rehabilitation + Bicycle Ergometer with Functional Electric Stimulation
Bicycle Ergometer with Functional Electric Stimulation Therapy in addition to conventional rehabilitation of the lower extremity in stroke patients
|
Lower extremity conventional rehabilitation in stroke patients
Bicycle ergometer with functional electric stimulation therapy of the lower extremity in stroke patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Fugl Meyer Lower Extremity Motor Subscale
Time Frame: Before treatment (0. week), finishing time of treatment (6.week)
|
Before treatment (0. week), finishing time of treatment (6.week)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Brunnstrom Staging
Time Frame: Before treatment (0. week), finishing time of treatment (6.week)
|
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)
|
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)
|
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)
|
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)
|
Before treatment (0. week), finishing time of treatment (6.week)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Engin Koyuncu, Prof. Dr., Gaziler Physical Therapy and Rehabilitation Training and Research Hospital
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)
October 1, 2023
Primary Completion (Actual)
August 1, 2024
Study Completion (Actual)
August 1, 2024
Study Registration Dates
First Submitted
August 14, 2024
First Submitted That Met QC Criteria
August 15, 2024
First Posted (Actual)
August 19, 2024
Study Record Updates
Last Update Posted (Actual)
November 19, 2025
Last Update Submitted That Met QC Criteria
November 17, 2025
Last Verified
August 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E1-23-4032
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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