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

Abant Izzet Baysal University

Status: Completed

Conditions: Hemiplegia

Treatments: Other: Cycling Functional Electrical Stimulation in addition to Conservative Rehabilitation; Other: Conservative rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05667025

AIBU-FTR-SK-05

Details and patient eligibility

About

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

Full 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

Enrollment: 30 patients

Sex: All

Ages: 25 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Conservative Rehabilitation

Active Comparator group

Description:

Conservative Rehabilitation

Treatment:

Other: Conservative rehabilitation

Cycling Functional Electrical Stimulation in addition to Conservative Rehabilitation

Active Comparator group

Description:

Cycling Functional Electrical Stimulation in addition to Conservative Rehabilitation

Treatment:

Other: Cycling Functional Electrical Stimulation in addition to Conservative Rehabilitation

Other: Conservative rehabilitation