The EFFECT of FUNCTIONAL ELECTRICAL STIMULATING on PHYSICAL ACTIVITY and QUALITY of LIFE in PATIENTS with PARALIS AFTER THROMBECTOMY: a RANDOMIZED CONTROLLED STUDY

March 7, 2025 updated by: Ceylan Kisial, Cukurova University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
    • Yüreğir
      • Adana, Yüreğir, Turkey, 01220
        • Recruiting
        • Adana City Training and Research Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group to be applied FES
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.
Other: Experimental group to be applied FES

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.
No Intervention: control group
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quick DASH (Arm Shoulder and Hand Injury Questionnaire Short Form)
Time Frame: 5 days
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.
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cukurova University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2023

Primary Completion (Estimated)

March 30, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

July 27, 2023

First Submitted That Met QC Criteria

July 27, 2023

First Posted (Actual)

August 4, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 7, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CU-SBF-CK-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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