HemiplegiaNCT05667025
Comparison of the Effects of Cycling FES and Conservative Rehabilitation Therapy on Stroke Patients
A study testing Conservative rehabilitation and Cycling Functional Electrical Stimulation in addition to Conservative Rehabilitation in people with Hemiplegia, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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 Read more about this study
- Who is it for?
- Ages 25 to 85 years
- Conditions the study is for
- Hemiplegia
- What is being tested?
- Conservative rehabilitation and Cycling Functional Electrical Stimulation in addition to Conservative Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
Comparison of the effects of cycling functional electrical stimulation and conservative rehabilitation therapy on the functional status and muscle characteristics of stroke patients
Read the 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
- Being tested
- Conservative rehabilitation, Cycling Functional Electrical Stimulation in addition to Conservative Rehabilitation
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative rehabilitationOther
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 RehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Conservative Rehabilitation | Active comparator | Conservative Rehabilitation Receives: Other: Conservative rehabilitation |
| Cycling Functional Electrical Stimulation in addition to Conservative Rehabilitation | Active comparator | Cycling Functional Electrical Stimulation in addition to Conservative Rehabilitation Receives: Other: Conservative rehabilitation; Other: Cycling Functional Electrical Stimulation in addition to Conservative Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Before Treatment
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
Measured: 6 Week After Treatment
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.
Measured: Before Treatment
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.
Measured: 6 Week After Treatment
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.
Measured: Before Treatment
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.
Measured: 6 Week After Treatment
Secondary outcomes (16)
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.
Measured: Before Treatment
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.
Measured: 6 Week After Treatment
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.
Measured: Before Treatment
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.
Measured: 6 Week After Treatment
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.
Measured: Before Treatment
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.
Measured: 6 Week After Treatment
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.
Measured: Before Treatment
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.
Measured: 6 Week After Treatment
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.
Measured: Before Treatment
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.
Measured: 6 Week After Treatment
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.
Measured: Before Treatment
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.
Measured: 6 Week After Treatment
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.
Measured: Before Treatment
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.
Measured: 6 Week After Treatment
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.
Measured: Before Treatment
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.
Measured: 6 Week After Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start1 Oct 2022
- Primary completion1 Oct 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serdar Kilinc, Abant Izzet Baysal University
- Investigators
- Serdar Kılınç, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667025
- Sponsor's protocol ID
- AIBU-FTR-SK-05
- Status last verified
- Jan 2024
- First submitted
- 19 Dec 2022
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05667025
- Acronym / sponsor ID
- AIBU-FTR-SK-05
- Conditions
- Hemiplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 28 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative Rehabilitation | Active comparator | Other: Conservative rehabilitationConservative Rehabilitation |
| Cycling Functional Electrical Stimulation in addition to Conservative Rehabilitation | Active comparator | Other: Conservative rehabilitation, Other: Cycling Functional Electrical Stimulation in addition to Conservative RehabilitationCycling Functional Electrical Stimulation in addition to Conservative Rehabilitation |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conservative rehabilitationJoint 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 | Other | Conservative Rehabilitation, Cycling Functional Electrical Stimulation in addition to Conservative Rehabilitation |
| Cycling Functional Electrical Stimulation in addition to Conservative RehabilitationIn 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. | Other | Cycling Functional Electrical Stimulation in addition to Conservative Rehabilitation |
Primary outcome
Berg Balance Scale
Time frame: Before Treatment
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
Time frame: 6 Week After Treatment
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
Time frame: Before Treatment
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
Time frame: 6 Week After Treatment
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
Time frame: Before Treatment
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
Time frame: 6 Week After Treatment
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.
16 secondary outcomes
Barthel Index
Time frame: Before Treatment
Barthel Index
Time frame: 6 Week After Treatment
Modified Ashworth Scale
Time frame: Before Treatment
Modified Ashworth Scale
Time frame: 6 Week After Treatment
6 min walking test
Time frame: Before Treatment
6 min walking test
Time frame: 6 Week After Treatment
Fatigue Severity Scale
Time frame: Before Treatment
Fatigue Severity Scale
Time frame: 6 Week After Treatment
Rectus Femoris Muscle Thickness
Time frame: Before Treatment
Rectus Femoris Muscle Thickness
Time frame: 6 Week After Treatment
Pennate angle
Time frame: Before Treatment
Pennate angle
Time frame: 6 Week After Treatment
Muscle strength measurement:
Time frame: Before Treatment
Muscle strength measurement:
Time frame: 6 Week After Treatment
Fugl-Meyer Assessment for lower extremity
Time frame: Before Treatment
Fugl-Meyer Assessment for lower extremity
Time frame: 6 Week After Treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serdar Kılınç principal investigator
Abant Izzet Baysal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conservative rehabilitation and Cycling Functional Electrical Stimulation in addition to Conservative Rehabilitation in people with Hemiplegia, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: Before Treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.