Effectiveness of Functional Electric Stimulation With Bicycle Ergometer and Mirror Therapy in Stroke Patients Lower Extremity

NCT ID: NCT06558721

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-08-01

Brief Summary

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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

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Aim of study is to compare functional electric stimulation with bicycle ergometer therapy and mirror therapy applied to lower extremity in stroke patients.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional Rehabilitation

Lower extremity conventional rehabilitation in stroke patients

Group Type ACTIVE_COMPARATOR

Conventional rehabilitation

Intervention Type OTHER

Lower extremity conventional rehabilitation in stroke patients

Conventional Rehabilitation + Mirror Therapy

Mirror therapy in addition to conventional rehabilitation of the lower extremity in stroke patients

Group Type ACTIVE_COMPARATOR

Conventional rehabilitation

Intervention Type OTHER

Lower extremity conventional rehabilitation in stroke patients

Mirror therapy

Intervention Type OTHER

Mirror therapy of the lower extremity in stroke patients

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

Group Type ACTIVE_COMPARATOR

Conventional rehabilitation

Intervention Type OTHER

Lower extremity conventional rehabilitation in stroke patients

Bicycle ergometer with functional electric stimulation

Intervention Type DEVICE

Bicycle ergometer with functional electric stimulation therapy of the lower extremity in stroke patients

Interventions

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Conventional rehabilitation

Lower extremity conventional rehabilitation in stroke patients

Intervention Type OTHER

Mirror therapy

Mirror therapy of the lower extremity in stroke patients

Intervention Type OTHER

Bicycle ergometer with functional electric stimulation

Bicycle ergometer with functional electric stimulation therapy of the lower extremity in stroke patients

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Muhammed Sefa Cınar

Asist. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Engin Koyuncu, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Gaziler Physical Therapy and Rehabilitation Training and Research Hospital

Locations

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Gaziler Physical Medicine and Rehabilitation Training and Research Hospital

Ankara, Çankaya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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E1-23-4032

Identifier Type: -

Identifier Source: org_study_id

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