Clinical trial NCT06558721: Effectiveness of Functional Electric Stimulation With Bicycle Ergometer and Mirror Therapy in Stroke Patients Lower Extremity
Official title: Comparison of the Effectiveness of Mirror Therapy and Functional Electrical Stimulation Bicycle Ergometry Therapy Applied to the Lower Extremity in Stroke Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke
Lower Extremity
Mirror Therapy
Functional Electric Stimulation
Bicycle Ergometer
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Fugl Meyer Lower Extremity Motor Subscale
timeFrame: Before treatment (0. week), finishing time of treatment (6.week)
Secondary outcomes:
measure: Brunnstrom Staging
timeFrame: Before treatment (0. week), finishing time of treatment (6.week)
measure: Berg Balance Scale
timeFrame: Before treatment (0. week), finishing time of treatment (6.week)
measure: Functional Independence Measure - Motor Score
timeFrame: Before treatment (0. week), finishing time of treatment (6.week)
measure: Stroke Specific Quality of Life Scale
timeFrame: Before treatment (0. week), finishing time of treatment (6.week)
measure: Functional Ambulation Scale
timeFrame: Before treatment (0. week), finishing time of treatment (6.week)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gaziler Physical Medicine and Rehabilitation Training and Research Hospital
state: Çankaya
Study officials:
affiliation: Gaziler Physical Therapy and Rehabilitation Training and Research Hospital
name: Engin Koyuncu, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: