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

Hemiplegia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05667025
• Other study ID #: AIBU-FTR-SK-05
• Status: Completed
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: January 30, 2024

Study information

• Verified date: January 2024
• Source: Abant Izzet Baysal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 30, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemiplegia

Intervention

Other:
• 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
• 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.

Locations

Country	Name	City	State
Turkey	Abant Izzet Baysal University	Bolu

Sponsors (1)

Lead Sponsor	Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Berg Balance Scale	The BBS is used to objectively determine a patient's ability to balance safely during a predetermined set of tasks. The scale comprises 14 items. Each item receives a score ranging from 0 to 4, which is a five-point rank scale with 0 indicating the lowest level of functioning and 4 indicating the highest level of functioning	Before Treatment
Primary	Berg Balance Scale	The BBS is used to objectively determine a patient's ability to balance safely during a predetermined set of tasks. The scale comprises 14 items. Each item receives a score ranging from 0 to 4, which is a five-point rank scale with 0 indicating the lowest level of functioning and 4 indicating the highest level of functioning	6 Week After Treatment
Primary	Functional Ambulation Scale	Functional Ambulation Scale is a 6-point functional walking test that evaluates ambulation ability and determines the amount of human support required by patients while walking, regardless of whether they use a personal assistive device. A score of 0 indicates that the patient has a dysfunctional ambulation A score of 5 denotes independent ambulation on any surface.	Before Treatment
Primary	Functional Ambulation Scale	Functional Ambulation Scale is a 6-point functional walking test that evaluates ambulation ability and determines the amount of human support required by patients while walking, regardless of whether they use a personal assistive device. A score of 0 indicates that the patient has a dysfunctional ambulation A score of 5 denotes independent ambulation on any surface.	6 Week After Treatment
Primary	Brunnstrom Stages	Brunnstrom stages is a scale used to assess motor recovery after a stroke, which is expressed using values between 1 and 6. The higher the value on this scale, the higher would be the recovery.	Before Treatment
Primary	Brunnstrom Stages	Brunnstrom stages is a scale used to assess motor recovery after a stroke, which is expressed using values between 1 and 6. The higher the value on this scale, the higher would be the recovery.	6 Week After Treatment
Secondary	Barthel Index	The Barthel index is used to assess activities of daily living. It consists of 10 items: feeding, bathing, grooming, dressing, bowel, bladder, toilet use, transfers, mobility, stairs. Scores range from 0-100. A score of 100 represents complete independence, and a score of 0 represents complete dependence.	Before Treatment
Secondary	Barthel Index	The Barthel index is used to assess activities of daily living. It consists of 10 items: feeding, bathing, grooming, dressing, bowel, bladder, toilet use, transfers, mobility, stairs. Scores range from 0-100. A score of 100 represents complete independence, and a score of 0 represents complete dependence.	6 Week After Treatment
Secondary	Modified Ashworth Scale	Spasticity in the shoulder will be evaluated according to the Modified Ashworth Scale (MAS). The Modified Ashworth Scale is a 6-point scale. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent increased degree of spasticity.	Before Treatment
Secondary	Modified Ashworth Scale	Spasticity in the shoulder will be evaluated according to the Modified Ashworth Scale (MAS). The Modified Ashworth Scale is a 6-point scale. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent increased degree of spasticity.	6 Week After Treatment
Secondary	6 min walking test	It is used to evaluate the functional capacity of patients. The patient is asked to walk in a 30-meter corridor marked at 3-meter intervals. At the end of the test, the distance walked by the patient is recorded in meters.	Before Treatment
Secondary	6 min walking test	It is used to evaluate the functional capacity of patients. The patient is asked to walk in a 30-meter corridor marked at 3-meter intervals. At the end of the test, the distance walked by the patient is recorded in meters.	6 Week After Treatment
Secondary	Fatigue Severity Scale	The scale consists of 9 questions that test the fatigue severity of the subjects in the last week. It is scored from 1 to 7. The result is found by the arithmetic mean. 4 or more indicates severe fatigue.	Before Treatment
Secondary	Fatigue Severity Scale	The scale consists of 9 questions that test the fatigue severity of the subjects in the last week. It is scored from 1 to 7. The result is found by the arithmetic mean. 4 or more indicates severe fatigue.	6 Week After Treatment
Secondary	Rectus Femoris Muscle Thickness	The linear probe of the ultrasound will be placed transversely at the midpoint of the distance between the trochanter major and the lateral space of the knee joint, and muscle thickness will be measured without applying pressure.	Before Treatment
Secondary	Rectus Femoris Muscle Thickness	The linear probe of the ultrasound will be placed transversely at the midpoint of the distance between the trochanter major and the lateral space of the knee joint, and muscle thickness will be measured without applying pressure.	6 Week After Treatment
Secondary	Pennate angle	Pennate angle can be defined as the angle of entry of muscle fibers into the aponeurosis. At the point where the rectus femoris muscle thickness is measured, the investigators will turn the ultrasound probe horizontally and measure the pennate angle formed by 3 different muscle fibers with the bottom fascia by goniometry and record the arithmetic average of these measurements.	Before Treatment
Secondary	Pennate angle	Pennate angle can be defined as the angle of entry of muscle fibers into the aponeurosis. At the point where the rectus femoris muscle thickness is measured, the investigators will turn the ultrasound probe horizontally and measure the pennate angle formed by 3 different muscle fibers with the bottom fascia by goniometry and record the arithmetic average of these measurements.	6 Week After Treatment
Secondary	Muscle strength measurement:	Knee extensor and flexor muscle strength will be measured with a North Coast hydraulic hand dynamometer. During the measurements, the knee will be in 90 degrees flexion while the patient is in a sitting position, the dynamometer will be placed in front of the ankle and the patient will be asked to push the dynamometer with all his strength, 3 measurements will be made and the average will be recorded as isometric knee extensor muscle strength. In the same way, the dynamometer will be placed behind the ankle and the patient will be asked to push the dynamometer with all his strength, the average of the 3 measurements will be taken and recorded as isometric knee flexor muscle strength.	Before Treatment
Secondary	Muscle strength measurement:	Knee extensor and flexor muscle strength will be measured with a North Coast hydraulic hand dynamometer. During the measurements, the knee will be in 90 degrees flexion while the patient is in a sitting position, the dynamometer will be placed in front of the ankle and the patient will be asked to push the dynamometer with all his strength, 3 measurements will be made and the average will be recorded as isometric knee extensor muscle strength. In the same way, the dynamometer will be placed behind the ankle and the patient will be asked to push the dynamometer with all his strength, the average of the 3 measurements will be taken and recorded as isometric knee flexor muscle strength.	6 Week After Treatment
Secondary	Fugl-Meyer Assessment for lower extremity	In the lower extremity motor subscale, reflex activity in supine and sitting positions, flexor synergy in supine position, extensor synergy in side-lying position, combined synergies in sitting, non-synergy movements in standing, normal reflexes in sitting position are examined. Each item is scored with a 3-point ordinal scale (0: unable at all, 1: partially able, 2: fully able). The maximum score is 28.	Before Treatment
Secondary	Fugl-Meyer Assessment for lower extremity	In the lower extremity motor subscale, reflex activity in supine and sitting positions, flexor synergy in supine position, extensor synergy in side-lying position, combined synergies in sitting, non-synergy movements in standing, normal reflexes in sitting position are examined. Each item is scored with a 3-point ordinal scale (0: unable at all, 1: partially able, 2: fully able). The maximum score is 28.	6 Week After Treatment