Cervical Proprioceptive Neuromuscular Facilitation and Stabilization Exercises in Stroke Patients

Comparison of the Effectiveness of Cervical Proprioceptive Neuromuscular Facilitation and Stabilization Exercises on Balance, Fall Risk and Fear of Falling in Stroke Patients

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.

Study Overview

• Status: Withdrawn
• Conditions: Stroke
• Intervention / Treatment: Other: PNF+ biofeedback exercise group

Detailed Description

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Gölcük
    • Kocaeli, Gölcük, Turkey
      • Güler Ertuğrul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Active Comparator: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mini Mental Test	It will be used to evaluate the cognitive status of patients. It is a simple, short and valid test that is widely used in stroke patients. With this test, various cognitive functions of people such as orientation, recording memory, attention and calculation, recall and language are evaluated. The maximum score that can be obtained from the test is 30. Getting a score of 24 or above indicates that the patient's cognitive functions are within normal limits.	four weeks
cervical joint position error test	In this test, the laser pointer on the helmet and the circle shown at 1 cm intervals are used as a target board. Patients are seated in a chair with back support, 90 cm away from the target board fixed to the wall. Patients are first asked to memorize the position of their head without leaning in any direction and try to find the same point after an active head movement. Active head movements include flexion, extension, and right and left rotations. The desired movements are repeated 10 times. After the movement, the horizontal, vertical and global distances of each point returned to the starting point will be recorded. To calculate the test result, the average values of the incorrect distances in centimeters will be calculated.	four weeks
Tecnobody Prokin 252 balance platform	To measure balance performance, patients are given the Tecnobody Prokin 252 balance platform. The moving balance platform works with air piston servo motors. Thanks to the automatic engine locking function, the system instantly switches from dynamic measurement to static measurement and provides measurement of two different balances with objective results.	four weeks
Berg Balance Scale	Berg Balance Scale (BDI) is a scale that contains 14 instructions and scores between 0-4 are given by observing the patient's performance for each instruction. A score of 0 is given when the patient cannot do the activity at all, while a score of 4 is given when the patient completes the activity independently. The highest score is 56, 0-20 points indicate imbalance, 21-40 points indicate acceptable balance, and 41-56 points indicate good balance. It takes between 10 and 20 minutes to complete the scale.	four weeks
Timed-Up and Go Test	It is one of the most frequently preferred evaluation methods as it is a test that includes movement maneuvers used in daily life. The test begins with a sitting position on a chair. The person is asked to get up from the chair he/she is sitting on, walk 3 meters at a safe and normal speed, turn, walk back and sit on the chair again. The time it takes to complete the test is recorded in seconds. While healthy individuals generally complete the test in less than 10 s, individuals who complete it in more than 30 s are classified as dependent on many activities of daily life and mobility skills.	four weeks
Modified Fall Activity Scale	14 items (10 indoor and 4 outdoor activities) assess confidence when performing different daily tasks. Items on the scale are scored from 0 (unsafe) to 10 (completely safe) to rate participants' level of fall-related self-efficacy.	four weeks

Collaborators and Investigators

• Sponsor: Suleyman Demirel University
• Investigators: Principal Investigator: GÜLER ERTUĞRUL, Süleyman Demirel University Faculty of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Estimated): July 28, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: January 24, 2024
• First Submitted That Met QC Criteria: January 24, 2024
• First Posted (Actual): February 1, 2024

Study Record Updates

• Last Update Posted (Actual): June 17, 2025
• Last Update Submitted That Met QC Criteria: June 13, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: proprioception; balance; fall; stabilization exercises
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: 791 (Oregon Clinical and Translational Research Institute)

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