ThrombectomyNCT05975697
The EFFECT of FUNCTIONAL ELECTRICAL STIMULATING on PHYSICAL ACTIVITY and QUALITY of LIFE in PATIENTS with PARALIS AFTER THROMBECTOMY: a RANDOMIZED CONTROLLED STUDY
A study testing Experimental group to be applied FES in people with Thrombectomy, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
It is planned as a randomized controlled intervention study to determine the effect of functional electrical stimulation (FES) on physical activity and quality of life in patients with paralysis after thrombectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombectomy
- What is being tested?
- Experimental group to be applied FES
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2023to 1 Apr 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old,
- Thrombectomy procedure was performed,
- Glasgow Coma Score (GCS) > 12 after thrombectomy
- Able to communicate,
- Having upper extremity paralysis,
- No pacemaker, advanced spasticity and muscle atrophy, peripheral lesions, osteoporosis, skin irritation and obesity,
- No skin and peripheral circulation problems,
- Patients whose relatives gave consent to the research.
Who cannot join
- Patients who did not comply with the sampling criteria and who developed complications that caused brain damage during the study (convulsions, mental disorder/delirium, vomiting, tremor, myoclonus) and whose relatives did not approve of the study will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Adana City Training and Research Hospital
Adana, Yüreğir, 01220
Ceylan Kişial, Master, 05068010561, cylnksl@hotmail.com
Cansel Bozer, 05434332624, cansel9815@gmail.com
About this study
It is planned as a randomized controlled intervention study to determine the effect of functional electrical stimulation (FES) on physical activity and quality of life in patients with paralysis after thrombectomy.
Read the detailed description
Thrombectomy is an interventional radiology procedure, and especially a method used endovascularly, and is the removal of a blood clot formed in arteries and veins (Yıldırım, 2023). Timely restoration of cerebral blood flow using reperfusion therapy is the most effective maneuver to save uninfarcted ischemic brain tissue (Jadhav at al., 2018). As the benefit of reperfusion decreases over time, one of the most common complications as a result of increasing ischemic areas is paralysis (Powers at al., 2019).
Paralysis often leads to significant impairment in upper extremity function and is associated with reduced quality of life in all domains except mobility (Franceschini at al., 2010). More than half of the patients may become partially or completely dependent on others in daily activities (Aşiret at al., 2013; Coban., 2013; Rahmani Anaraki at al., 2013; Kheirollahi at al., 2013). However, few patients achieve full functional recovery, and this deficiency impairs the performance of all physical activities, including self-care and social activities (Kwakkel at al., 2003). Different therapeutic methods are used to prevent or reduce the long-term deterioration of the upper extremities in patients undergoing thrombectomy (Vafadar at al., 2015). Among these therapeutic methods, non-pharmacological methods are much easier to learn, safe and without definite contraindications (Howlett at al., 2015).
According to the studies reviewed, functional electrical stimulation (FES) is a non-pharmacological method, which is a device that electrically stimulates motor neurons to improve motor functions aimed at stimulating the nerves of weakened muscles (Lynch at al., 2008; Niu, at al., 2022). Transcutaneous electrodes offer an easy and fast treatment option because they are non-invasive (Eraifej at al., 2017).
As a result of the literature review, FES (Bolton at al., 2004; Howlett at al., 2015; Meilink at al., 2008; Vafadar at al., 2015; Van Peppen at al., 2004) has proven its effectiveness in the rehabilitation of the lower extremity after thrombectomy. , and there is no clarity about the effectiveness of FES in upper extremity rehabilitation (Stroke rehabilitation in adults. Published June 2013. Accessed 1 Jan 2016). This is partly due to methodological limitations (Howlett at al., 2015; Vafadar at al., 2015) or the outdated nature of some existing studies (Bolton at al., 2004; Meilink at al., 2008; Van Peppen at al., 2004). ). It was also highlighted by a recent Cochrane review that required a current review and meta-analysis of randomized controlled trials (RCTs) on electrical stimulation (Pollock at al., 2014). The most recent recent systematic review found a significant improvement in motor outcomes with the upper extremity FES (Howlett at al., 2015).
In this context, FES application in our country is one of the functional applications of nurses to correct the activity with the doctor and to exercise management (https://www.resmigazete.gov.tr/eskiler/2011/04/20110419-5.htm). In our study, we aimed to base the effect of functional electrical stimulation (FES) on physical activity and quality of life in patients with paralysis after thrombectomy, and to form a source for current and similar studies.
- Conditions
- Thrombectomy
- Being tested
- Experimental group to be applied FES
- Keywords
- Thrombectomy, FES, PHYSICAL ACTIVITY, LIFE QUALITY, Nursing
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental group to be applied FESOther
In the first 24 hours after the thrombectomy procedure, the relatives of the patients in the experimental and control groups who meet the inclusion criteria will be informed by the researcher and their consent will be obtained.
FES treatment to the deltoid, triceps, extensor carpi radialis muscles for a total of 10 sessions, 30 minutes twice a day (in the morning and in the evening), for 5 days after the first 24th hour after the thrombectomy procedure in the experimental group patients (Program duration is 15 minutes and resting time is 15 minutes). minutes) will be applied.Patient information form (Appendix 1), Fugl-meyer upper extremity motor assessment scale (Appendix-2) and Quick DASH (Arm, Shoulder and Hand Injury Questionnaire Short Form) (Appendix-3) were given to both groups within the first 24 hours after the thrombectomy procedure. ) will be applied. All patients will be re-evaluated before and on the 5th day after treatment.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group to be applied FES | Experimental | FES treatment to the deltoid, triceps, extensor carpi radialis muscles for a total of 10 sessions, 30 minutes twice a day (in the morning and in the evening), for 5 days after the first 24th hour after the thrombectomy procedure in the experimental group patients (Program duration is 15 minutes and resting time is 15 minutes). minutes) will be applied. Receives: Other: Experimental group to be applied FES |
| control group | No intervention | In the control group patients; From the first 24 hours after the thrombectomy procedure, the routine of the clinic (such as not performing a non-pharmacological procedure) is applied for 5 days, and no other procedure will be performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Upper Extremity Motor Rating Scale (FMRS)
To assess motor function, the Fugl Meyer Rating Scale (FMRS) considers the upper extremity in 3 parts. These parts are shoulder-elbow-forearm, (upper arm) wrist and hand. The score evaluation is 36 points for the upper arm, 10 points for the wrist and 14 points for the hand evaluation. In the evaluation of coordination and speed, the maximum total score of the upper extremity is 66, out of 6 points.
Measured: 5 days
Secondary outcomes (1)
Quick DASH (Arm Shoulder and Hand Injury Questionnaire Short Form)
The questionnaire consists of 11 questions, and the difficulties of the patients during their daily living activities are examined. Each answer is scored from 1 to 5 on a Likert scale, from best to worst.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start20 Jul 2023
- Primary completion30 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombectomyStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- Model description
- Divided into two groups as experimental and control groups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceylan Kisial, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975697
- Sponsor's protocol ID
- CU-SBF-CK-01
- Status last verified
- Aug 2024
- First submitted
- 27 Jul 2023
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The EFFECT of FUNCTIONAL ELECTRICAL STIMULATING on PHYSICAL ACTIVITY and QUALITY of LIFE in PATIENTS with PARALIS AFTER THROMBECTOMY: a RANDOMIZED CONTROLLED STUDY
- ClinicalTrials.gov ID
- NCT05975697
- Acronym / sponsor ID
- CU-SBF-CK-01
- Conditions
- Thrombectomy
- Keywords
- Thrombectomy, FES, PHYSICAL ACTIVITY, LIFE QUALITY, Nursing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 4 Aug 2023 (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.
It is planned as a randomized controlled intervention study to determine the effect of functional electrical stimulation (FES) on physical activity and quality of life in patients with paralysis after thrombectomy.
Detailed description
Thrombectomy is an interventional radiology procedure, and especially a method used endovascularly, and is the removal of a blood clot formed in arteries and veins (Yıldırım, 2023). Timely restoration of cerebral blood flow using reperfusion therapy is the most effective maneuver to save uninfarcted ischemic brain tissue (Jadhav at al., 2018). As the benefit of reperfusion decreases over time, one of the most common complications as a result of increasing ischemic areas is paralysis (Powers at al., 2019).
Paralysis often leads to significant impairment in upper extremity function and is associated with reduced quality of life in all domains except mobility (Franceschini at al., 2010). More than half of the patients may become partially or completely dependent on others in daily activities (Aşiret at al., 2013; Coban., 2013; Rahmani Anaraki at al., 2013; Kheirollahi at al., 2013). However, few patients achieve full functional recovery, and this deficiency impairs the performance of all physical activities, including self-care and social activities (Kwakkel at al., 2003). Different therapeutic methods are used to prevent or reduce the long-term deterioration of the upper extremities in patients undergoing thrombectomy (Vafadar at al., 2015). Among these therapeutic methods, non-pharmacological methods are much easier to learn, safe and without definite contraindications (Howlett at al., 2015).
According to the studies reviewed, functional electrical stimulation (FES) is a non-pharmacological method, which is a device that electrically stimulates motor neurons to improve motor functions aimed at stimulating the nerves of weakened muscles (Lynch at al., 2008; Niu, at al., 2022). Transcutaneous electrodes offer an easy and fast treatment option because they are non-invasive (Eraifej at al., 2017).
As a result of the literature review, FES (Bolton at al., 2004; Howlett at al., 2015; Meilink at al., 2008; Vafadar at al., 2015; Van Peppen at al., 2004) has proven its effectiveness in the rehabilitation of the lower extremity after thrombectomy. , and there is no clarity about the effectiveness of FES in upper extremity rehabilitation (Stroke rehabilitation in adults. Published June 2013. Accessed 1 Jan 2016). This is partly due to methodological limitations (Howlett at al., 2015; Vafadar at al., 2015) or the outdated nature of some existing studies (Bolton at al., 2004; Meilink at al., 2008; Van Peppen at al., 2004). ). It was also highlighted by a recent Cochrane review that required a current review and meta-analysis of randomized controlled trials (RCTs) on electrical stimulation (Pollock at al., 2014). The most recent recent systematic review found a significant improvement in motor outcomes with the upper extremity FES (Howlett at al., 2015).
In this context, FES application in our country is one of the functional applications of nurses to correct the activity with the doctor and to exercise management (https://www.resmigazete.gov.tr/eskiler/2011/04/20110419-5.htm). In our study, we aimed to base the effect of functional electrical stimulation (FES) on physical activity and quality of life in patients with paralysis after thrombectomy, and to form a source for current and similar studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Divided into two groups as experimental and control groups.
| Arm | Type | Receives |
|---|---|---|
| Experimental group to be applied FES | Experimental | Other: Experimental group to be applied FESFES treatment to the deltoid, triceps, extensor carpi radialis muscles for a total of 10 sessions, 30 minutes twice a day (in the morning and in the evening), for 5 days after the first 24th hour after the thrombectomy procedure in the experimental group patients (Program duration is 15 minutes and resting time is 15 minutes). minutes) will be applied. |
| control group | No intervention | –In the control group patients; From the first 24 hours after the thrombectomy procedure, the routine of the clinic (such as not performing a non-pharmacological procedure) is applied for 5 days, and no other procedure will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Over 18 years old,
- Thrombectomy procedure was performed,
- Glasgow Coma Score (GCS) > 12 after thrombectomy
- Able to communicate,
- Having upper extremity paralysis,
Key exclusion criteria (1 listed)
- Patients who did not comply with the sampling criteria and who developed complications that caused brain damage during the study (convulsions, mental disorder/delirium, vomiting, tremor, myoclonus) and whose relatives did not approve of the study will not be included in the study.
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 |
|---|---|---|
| Experimental group to be applied FESIn the first 24 hours after the thrombectomy procedure, the relatives of the patients in the experimental and control groups who meet the inclusion criteria will be informed by the researcher and their consent will be obtained. FES treatment to the deltoid, triceps, extensor carpi radialis muscles for a total of 10 sessions, 30 minutes twice a day (in the morning and in the evening), for 5 days after the first 24th hour after the thrombectomy procedure in the experimental group patients (Program duration is 15 minutes and resting time is 15 minutes). minutes) will be applied.Patient information form (Appendix 1), Fugl-meyer upper extremity motor assessment scale (Appendix-2) and Quick DASH (Arm, Shoulder and Hand Injury Questionnaire Short Form) (Appendix-3) were given to both groups within the first 24 hours after the thrombectomy procedure. ) will be applied. All patients will be re-evaluated before and on the 5th day after treatment. | Other | Experimental group to be applied FES |
Primary outcome
Fugl-Meyer Upper Extremity Motor Rating Scale (FMRS)
Time frame: 5 days
To assess motor function, the Fugl Meyer Rating Scale (FMRS) considers the upper extremity in 3 parts. These parts are shoulder-elbow-forearm, (upper arm) wrist and hand. The score evaluation is 36 points for the upper arm, 10 points for the wrist and 14 points for the hand evaluation. In the evaluation of coordination and speed, the maximum total score of the upper extremity is 66, out of 6 points.
1 secondary outcome
Quick DASH (Arm Shoulder and Hand Injury Questionnaire Short Form)
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group to be applied FES in people with Thrombectomy, run by Cukurova 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 8 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Mar 2025. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ceylan Kişial, Master (05068010561, cylnksl@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Upper Extremity Motor Rating Scale (FMRS) (time frame: 5 days). 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 11 Mar 2025.