Comparison of the Effects of Cycling FES and Conservative Rehabilitation Therapy on Stroke Patients

NCT ID: NCT05667025

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-01-30

Brief Summary

Comparison of the effects of cycling functional electrical stimulation and conservative rehabilitation therapy on the functional status and muscle characteristics of stroke patients

Detailed Description

Stroke is the second leading cause of death worldwide and is a major contributor to disability. It is one of the developments related to bleeding as a result of occlusion of blood vessels in the brain with a clot or damage from the vessels.Loss of strength and motor coordination in the lower and upper extremities is the main cause of disability after stroke. Activities such as walking, standing, sitting and daily activities such as dressing, bathing and toilet are frequently affected and sensorimotor disorders are common.

Functional electrical stimulation (FES) is one of the methods used in treatment. FES provides muscle contraction and movement by electrical stimulation of motor neurons. It is applied by a controller through skin electrodes to induce contractions. The FES-evoked bike allows people with or without voluntary leg movement to pedal an exercise bike on a fixed system.

In this study, the investigators aimed to compare the treatment efficacy and changes in muscle characteristics of conservative treatment and cycling FES in stroke patients.

Demographic data of the patients and healthy volunteers will be recorded. Hemiplegic patients will be evaluated in terms of Barthel Index, Modified Ashworth Scale, Berg Balance Scale, Functional Ambulation Scale, Brunnstrom's Hemiplegia Recovery Stage, Fatigue Severity Scale, Fugl-Meyer Assessment, 6-Minute Walking Test, Muscle strength measurement, pennation angle and thickness measurement of the musculus rectus femoris muscle

Conditions

Hemiplegia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Conservative Rehabilitation

Conservative Rehabilitation

Group Type: ACTIVE_COMPARATOR

Conservative rehabilitation

Intervention Type: OTHER

Joint range of motion, strengthening, balance-coordination and stretching exercises included in the conservative physiotherapy program 5 days a week for a total of 6 weeks

Cycling Functional Electrical Stimulation in addition to Conservative Rehabilitation

Cycling Functional Electrical Stimulation in addition to Conservative Rehabilitation

Group Type: ACTIVE_COMPARATOR

Conservative rehabilitation

Intervention Type: OTHER

Joint range of motion, strengthening, balance-coordination and stretching exercises included in the conservative physiotherapy program 5 days a week for a total of 6 weeks

Cycling Functional Electrical Stimulation in addition to Conservative Rehabilitation

Intervention Type: OTHER

In addition to conservative treatment, cycling FES to the affected lower extremity for 20 minutes, 3 days a week for 4 weeks. During the treatment, the patient will be seated on a chair and her feet will be fixed to the pedal with velcro tape, and the comfort during the treatment will be provided with calf supports.

Interventions

Conservative rehabilitation

Joint range of motion, strengthening, balance-coordination and stretching exercises included in the conservative physiotherapy program 5 days a week for a total of 6 weeks

Intervention Type: OTHER

Cycling Functional Electrical Stimulation in addition to Conservative Rehabilitation

In addition to conservative treatment, cycling FES to the affected lower extremity for 20 minutes, 3 days a week for 4 weeks. During the treatment, the patient will be seated on a chair and her feet will be fixed to the pedal with velcro tape, and the comfort during the treatment will be provided with calf supports.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients must be between the ages of 21-85.
• The time elapsed after stroke must be between 3-60 months.
• Patients must have had cerebrovascular disease for the first time.
• Patients' Functional Ambulation Scale grade ≤ 4
• Patients must be able to sit unsupported for 30 minutes and walk 6 meters with support or device.
• Patients' mini mental test score ≥ 24

Exclusion Criteria

• Patients with peripheral nerve injury in the lower extremity
• Patients with a pacemaker or a pacemaker.
• Patients with severe spasticity of the lower extremities
• Patients with a history of more than one cerebrovascular disease
• Patients with a history of lower extremity fractures in the last 6 months
• Patients diagnosed with Parkinson, Multiple Sclerosis
• Patients with unstable cardiac pathology
• Patients' mini mental test score ≤ 24

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abant Izzet Baysal University

OTHER

Sponsor Role: lead

Responsible Party

Serdar Kilinc

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Serdar Kılınç

Role: PRINCIPAL_INVESTIGATOR

Abant Izzet Baysal University

Locations

Abant Izzet Baysal University

Bolu, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AIBU-FTR-SK-05

Identifier Type: -

Identifier Source: org_study_id