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

Primary Purpose

Hemiplegia

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Conservative rehabilitation
Cycling Functional Electrical Stimulation in addition to Conservative Rehabilitation
Sponsored by
Abant Izzet Baysal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegia

Eligibility Criteria

25 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Abant Izzet Baysal UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Conservative Rehabilitation

Cycling Functional Electrical Stimulation in addition to Conservative Rehabilitation

Arm Description

Conservative Rehabilitation

Cycling Functional Electrical Stimulation in addition to Conservative Rehabilitation

Outcomes

Primary Outcome Measures

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
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
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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 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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
December 19, 2022
Last Updated
December 27, 2022
Sponsor
Abant Izzet Baysal University
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1. Study Identification

Unique Protocol Identification Number
NCT05667025
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abant Izzet Baysal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conservative Rehabilitation
Arm Type
Active Comparator
Arm Description
Conservative Rehabilitation
Arm Title
Cycling Functional Electrical Stimulation in addition to Conservative Rehabilitation
Arm Type
Active Comparator
Arm Description
Cycling Functional Electrical Stimulation in addition to Conservative Rehabilitation
Intervention Type
Other
Intervention Name(s)
Conservative rehabilitation
Intervention Description
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
Intervention Name(s)
Cycling Functional Electrical Stimulation in addition to Conservative Rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Berg Balance Scale
Description
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
Time Frame
Before Treatment
Title
Berg Balance Scale
Description
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
Time Frame
6 Week After Treatment
Title
Functional Ambulation Scale
Description
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.
Time Frame
Before Treatment
Title
Functional Ambulation Scale
Description
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.
Time Frame
6 Week After Treatment
Title
Brunnstrom Stages
Description
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.
Time Frame
Before Treatment
Title
Brunnstrom Stages
Description
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.
Time Frame
6 Week After Treatment
Secondary Outcome Measure Information:
Title
Barthel Index
Description
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.
Time Frame
Before Treatment
Title
Barthel Index
Description
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.
Time Frame
6 Week After Treatment
Title
Modified Ashworth Scale
Description
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.
Time Frame
Before Treatment
Title
Modified Ashworth Scale
Description
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.
Time Frame
6 Week After Treatment
Title
6 min walking test
Description
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.
Time Frame
Before Treatment
Title
6 min walking test
Description
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.
Time Frame
6 Week After Treatment
Title
Fatigue Severity Scale
Description
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.
Time Frame
Before Treatment
Title
Fatigue Severity Scale
Description
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.
Time Frame
6 Week After Treatment
Title
Rectus Femoris Muscle Thickness
Description
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.
Time Frame
Before Treatment
Title
Rectus Femoris Muscle Thickness
Description
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.
Time Frame
6 Week After Treatment
Title
Pennate angle
Description
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.
Time Frame
Before Treatment
Title
Pennate angle
Description
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.
Time Frame
6 Week After Treatment
Title
Muscle strength measurement:
Description
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.
Time Frame
Before Treatment
Title
Muscle strength measurement:
Description
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.
Time Frame
6 Week After Treatment
Title
Fugl-Meyer Assessment for lower extremity
Description
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.
Time Frame
Before Treatment
Title
Fugl-Meyer Assessment for lower extremity
Description
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.
Time Frame
6 Week After Treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Serdar Kılınç
Phone
9050559113181
Email
drserdarkilinc@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serdar Kılınç
Organizational Affiliation
Abant Izzet Baysal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abant Izzet Baysal University
City
Bolu
ZIP/Postal Code
14100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serdar Kılınç
Phone
905055913181
Email
drserdarkilinc@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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