Cervical Proprioceptive Neuromuscular Facilitation and Stabilization Exercises in Stroke Patients

NCT ID: NCT06237140

Last Updated: 2025-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-15

Study Completion Date

2024-12-30

Brief Summary

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Randomization order tracking will be done with sequentially numbered containers. Patients participating in the study will be blinded as to which treatment group they will be included in. Before the study, written and verbal "Informed Consent Form" will be obtained from all participants who meet the inclusion criteria. In order to prevent bias, participants assigned to groups will be evaluated by a blind physiotherapist. Tests; The treatment of patients in the study and control groups will be carried out one day before the start, and all evaluations will be repeated after the 4-week neurorehabilitation process is completed. All data obtained will be noted on the prepared evaluation form.

Detailed Description

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Randomization order tracking will be done with sequentially numbered containers. Patients participating in the study will be blinded to which treatment group they will be included in. Before the study, written and verbal "Informed Consent Form" will be obtained from all participants who meet the inclusion criteria. After the sociodemographic and clinical features of the participants are recorded, the cognitive status of the patients will be evaluated with MMT. Participants' neck proprioceptive senses, cervical proprioceptive awareness, cervical joint failure test, falling risks, dynamic and static balance tests on the Tecnobody Prokin 252 Isokinetic Balance Platform, among objective tests, Timed up and go test and Berg balance test, among clinical tests, and their fear of falling, Modified. It will be evaluated with the Fall Effectiveness Scale. To avoid bias, evaluations will be made by a blind physiotherapist to the participants assigned to the groups. Tests; It will be done one day before the treatments to the patients in the study and control groups begin, and all evaluations will be repeated after the 4-week neurorehabilitation process is completed. All data obtained will be noted on a prepared evaluation form.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomization order tracking will be done with sequentially numbered containers. Patients participating in the study will be blinded to which treatment group they will be included in.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Patients participating in the study will be blinded to which treatment group they will be included in. The evaluations of the patients participating in the study will be evaluated by a physiotherapist who is blind to group assignments. During treatment, physical therapists will be instructed not to communicate with patients about the possible goals or rationale for either treatment. A professional who is blind to the evaluation results of the groups will perform the statistical analysis.

Study Groups

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PNF exercise group

proprioceptive neuromuscular facilitation (PNF) techniques will be applied to the cervical region. In the study, flexion-lateral flexion and rotation patterns will be studied together with antagonist patterns. In the antagonist movement involving cervical extension, the hand above the head is displaced diagonally and positioned to resist extension, lateral flexion and rotation. Before the exercise, the patient will be informed about the diagonal direction of the movement and made to feel it, and then the exercises will be performed in 5 sets, each set containing 10 repetitions. Participants will be given sufficient time to rest between sets.

Group Type EXPERIMENTAL

PNF+ biofeedback exercise group

Intervention Type OTHER

Neurorehabilitation will be applied to this group, 5 sessions a week for 4 weeks, to increase balance and walking skills and reduce the risk of falling.

biofeedback exercise group

cervical stabilization exercises will be used to stimulate cervical proprioceptors. Neck stabilization training will be applied with a low load to strengthen the longus capitis and longus colli, the deep muscles of the upper cervical vertebra. The oblique and costal muscles, which are the auxiliary respiratory muscles, will be relaxed and the neck will be flexed. A pressure biofeedback device will be placed on the upper cervical spine (below the occiput) while lying with the air pocket set at 20 mmHg to obtain visual feedback from the dial. The pressure will be gradually increased to 30 mmHg in 2 mmHg increments. While the patient was asked to retract his chin, the contraction duration was determined as 10 seconds. While the contractions are repeated 10 times, a 3-5 second rest period will be given between each contraction.

Group Type ACTIVE_COMPARATOR

PNF+ biofeedback exercise group

Intervention Type OTHER

Neurorehabilitation will be applied to this group, 5 sessions a week for 4 weeks, to increase balance and walking skills and reduce the risk of falling.

Interventions

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PNF+ biofeedback exercise group

Neurorehabilitation will be applied to this group, 5 sessions a week for 4 weeks, to increase balance and walking skills and reduce the risk of falling.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Volunteering to participate in the study
* Volunteering to participate in the study
* Being between the ages of 35-75
* Being diagnosed with stroke
* Having a stroke for the first time
* Mini Mental Test (MMT) Score ≥ 24
* Brunnstorm lower extremity stage ≥ 2
* Being clinically stable

Exclusion Criteria

* Mini Mental Score \< 24 points
* Having additional hearing and vestibular system problems
* Having problems with field of vision
* Orthopedically sourced platinum etc. on his body. having had an operation
* Having a cerebrum, cerebellar or spinal cord malignancy
* Having additional neurological lesions (MS, Parkinson's, Alzheimer's)
* Mini Mental Score \< 24 points
* Having cervical pain of 5 or higher on the visual analog scale
* Having serious vestibular, auditory and visual problems that affect balance (vertigo, etc.)
* Having a history of orthopedic surgery for the trunk and lower extremities
* Presence of an additional neurological disease (MS, Parkinson's, Alzheimer's)
* Having joint rigidity that prevents proprioceptive evaluation
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Suleyman Demirel University

OTHER

Sponsor Role lead

Responsible Party

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Güler ERTUĞRUL

MSc student, physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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GÜLER ERTUĞRUL

Role: PRINCIPAL_INVESTIGATOR

Süleyman Demirel University Faculty of Health Sciences

Locations

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Güler Ertuğrul

Kocaeli, Gölcük, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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791

Identifier Type: -

Identifier Source: org_study_id

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