Clinical trial NCT05667025: Comparison of the Effects of Cycling FES and Conservative Rehabilitation Therapy on Stroke Patients
Official title: Comparison of the Effects of Cycling Functional Electrical Stimulation and Conservative Rehabilitation Therapy on the Functional Status and Muscle Characteristics of Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegia
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2022-12-28
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Berg Balance Scale
timeFrame: Before Treatment
measure: Berg Balance Scale
timeFrame: 6 Week After Treatment
measure: Functional Ambulation Scale
timeFrame: Before Treatment
measure: Functional Ambulation Scale
timeFrame: 6 Week After Treatment
measure: Brunnstrom Stages
timeFrame: Before Treatment
measure: Brunnstrom Stages
timeFrame: 6 Week After Treatment
Secondary outcomes:
measure: Barthel Index
timeFrame: Before Treatment
measure: Barthel Index
timeFrame: 6 Week After Treatment
measure: Modified Ashworth Scale
timeFrame: Before Treatment
measure: Modified Ashworth Scale
timeFrame: 6 Week After Treatment
measure: 6 min walking test
timeFrame: Before Treatment
measure: 6 min walking test
timeFrame: 6 Week After Treatment
measure: Fatigue Severity Scale
timeFrame: Before Treatment
measure: Fatigue Severity Scale
timeFrame: 6 Week After Treatment
measure: Rectus Femoris Muscle Thickness
timeFrame: Before Treatment
measure: Rectus Femoris Muscle Thickness
timeFrame: 6 Week After Treatment
measure: Pennate angle
timeFrame: Before Treatment
measure: Pennate angle
timeFrame: 6 Week After Treatment
measure: Muscle strength measurement:
timeFrame: Before Treatment
measure: Muscle strength measurement:
timeFrame: 6 Week After Treatment
measure: Fugl-Meyer Assessment for lower extremity
timeFrame: Before Treatment
measure: Fugl-Meyer Assessment for lower extremity
timeFrame: 6 Week After Treatment
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Abant Izzet Baysal University
Study officials:
affiliation: Abant Izzet Baysal University
name: Serdar Kılınç
role: PRINCIPAL_INVESTIGATOR
References: