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

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Other: Conventional rehabilitation; Device: Bicycle ergometer with functional electric stimulation; Other: Mirror therapy

• Registration Number: NCT06558721
• Lead Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

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.

Study Timeline

• Study Start: 2023-10-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-14
• Study First Submitted QC: 2024-08-15
• Last Update Submitted: 2024-08-15
• Study First Posted: 2024-08-19
• Last Update Posted: 2024-08-19
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Rehabilitation + Bicycle Ergometer with Functional Electric Stimulation	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
Conventional Rehabilitation	Conventional rehabilitation	Lower extremity conventional rehabilitation in stroke patients
Conventional Rehabilitation + Mirror Therapy	Conventional rehabilitation	Mirror therapy in addition to conventional rehabilitation of the lower extremity in stroke patients
Conventional Rehabilitation + Bicycle Ergometer with Functional Electric Stimulation	Conventional rehabilitation	Bicycle Ergometer with Functional Electric Stimulation Therapy in addition to conventional rehabilitation of the lower extremity in stroke patients
Conventional Rehabilitation + Mirror Therapy	Mirror therapy	Mirror therapy in addition to conventional rehabilitation of the lower extremity in stroke patients

Primary Outcome Measures

Name	Time	Method
Fugl Meyer Lower Extremity Motor Subscale	Before treatment (0. week), finishing time of treatment (6.week)

Secondary Outcome Measures

Name	Time	Method
Berg Balance Scale	Before treatment (0. week), finishing time of treatment (6.week)
Functional Independence Measure - Motor Score	Before treatment (0. week), finishing time of treatment (6.week)
Brunnstrom Staging	Before treatment (0. week), finishing time of treatment (6.week)
Stroke Specific Quality of Life Scale	Before treatment (0. week), finishing time of treatment (6.week)
Functional Ambulation Scale	Before treatment (0. week), finishing time of treatment (6.week)

Trial Locations

Locations (1)

Gaziler Physical Medicine and Rehabilitation Training and Research Hospital; 🇹🇷 Ankara, Çankaya, Turkey