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

NCT05975697 | Recruiting

• 1 other identifier: CU-SBF-CK-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thrombectomy

Keywords

Thrombectomy; FES; PHYSICAL ACTIVITY; LIFE QUALITY; Nursing

Outcome Measures

Primary Outcomes (1)

• 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.

  5 days

Secondary Outcomes (1)

• Quick DASH (Arm Shoulder and Hand Injury Questionnaire Short Form)

  5 days

Study Arms (2)

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.

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.

Interventions

Experimental group to be applied FES OTHER

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.

Experimental group to be applied FES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Adana City Training and Research Hospital

Adana, Yüreğir, 01220, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Ceylan Kişial, Master

CONTACT

05068010561; cylnksl@gmail.com

Cansel Bozer, Master

CONTACT

05434332624; cansel9815@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The study is planned to be double-blind, and the patient and the evaluating physician will not know which patient is in the study group and which patient is in the control group. The walkers and the physiotherapist will not be blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Model Details: Divided into two groups as experimental and control groups.

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 4, 2023
• Study Start: July 20, 2023
• Primary Completion: March 30, 2025
• Study Completion: April 1, 2025
• Last Updated: March 11, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)