StrokeNCT06237140
Cervical Proprioceptive Neuromuscular Facilitation and Stabilization Exercises in Stroke Patients
A study testing PNF+ biofeedback exercise group in people with Stroke, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- PNF+ biofeedback exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2023to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- PNF+ biofeedback exercise group
- Keywords
- proprioception, stabilization exercises, balance, fall
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNF+ biofeedback exercise groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| PNF exercise group | Experimental | 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. Receives: Other: PNF+ biofeedback exercise group |
| biofeedback exercise group | Active comparator | 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. Receives: Other: PNF+ biofeedback exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start15 Sep 2023
- Primary completion28 Jul 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Why it stopped: Trial was registered in error.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Güler ERTUĞRUL, Suleyman Demirel University
- Investigators
- GÜLER ERTUĞRUL, Principal investigator, Süleyman Demirel University Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237140
- Sponsor's protocol ID
- 791
- Status last verified
- Jun 2025
- First submitted
- 24 Jan 2024
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06237140
- Acronym / sponsor ID
- 791
- Conditions
- Stroke
- Keywords
- proprioception, stabilization exercises, balance, fall
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Trial was registered in error.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 28 Jul 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model 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.
| Arm | Type | Receives |
|---|---|---|
| PNF exercise group | Experimental | Other: PNF+ biofeedback exercise groupproprioceptive 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. |
| biofeedback exercise group | Active comparator | Other: PNF+ biofeedback exercise groupcervical 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. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PNF+ biofeedback exercise groupNeurorehabilitation 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. | Other | PNF exercise group, biofeedback exercise group |
Primary outcome
Mini Mental Test
Time frame: four weeks
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.
cervical joint position error test
Time frame: four weeks
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.
Tecnobody Prokin 252 balance platform
Time frame: four weeks
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.
Berg Balance Scale
Time frame: four weeks
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.
Timed-Up and Go Test
Time frame: four weeks
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.
Modified Fall Activity Scale
Time frame: four weeks
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GÜLER ERTUĞRUL principal investigator
Süleyman Demirel University Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PNF+ biofeedback exercise group in people with Stroke, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini Mental Test (time frame: four weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.