Cervical Proprioceptive Neuromuscular Facilitation and Stabilization Exercises in Stroke Patients

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06237140
• Other study ID #: 791
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: January 2024
• Source: Suleyman Demirel University
• Contact: GÜLER ERTUGRUL
• Phone: +90 531 950 05 90
• Email: gertugrul004[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: December 30, 2024
• Est. primary completion date: July 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Turkey	Güler Ertugrul	Kocaeli	Gölcük

Sponsors (1)

Lead Sponsor	Collaborator
Suleyman Demirel University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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