Neurologic DisorderNCT07524790
The Effect of Proprioceptive Neuromuscular Facilitation on Haemodynamic Responses in a Neurological Intensive Care
A study testing Proprioceptive Neuromuscular Facilitation Exercises and Passive Range of Motion Exercises in people with Neurologic Disorder, run by Abant Izzet Baysal University.
Trial summary
Although there are studies examining the effect of actively performed PNF exercises on haemodynamic responses in intensive care patients and healthy individuals, there are no studies investigating their effect on circulation and haemodynamic responses in unconscious patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurologic Disorder
- What is being tested?
- Proprioceptive Neuromuscular Facilitation Exercises and Passive Range of Motion Exercises
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2026to 15 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients being monitored in the neurology intensive care unit
- Aged 18 years or over
- Haemodynamically stable
- No orthopaedic condition preventing the performance of passive joint movements in the upper and lower limbs
- A signed informed consent form from a patient's next of relative for participation in the study
Who cannot join
- Presence of haemodynamic instability
- Fractures, contractures or serious orthopaedic conditions in the upper or lower limbs that restrict movement
- Diagnosis or suspicion of deep vein thrombosis
- Severe peripheral arterial disease
- Serious cardiac arrhythmia that may prevent exercise
About this study
Official title: The Effect of Proprioceptive Neuromuscular Facilitation on the Ankle-Brachial Index and Haemodynamic Responses in Patients in a Neurological Intensive Care Unit: A Randomised Controlled Trial
Although there are studies examining the effect of actively performed PNF exercises on haemodynamic responses in intensive care patients and healthy individuals, there are no studies investigating their effect on circulation and haemodynamic responses in unconscious patients. Therefore, this study was designed to investigate the acute effects of proprioceptive neuromuscular facilitation (PNF) exercises on peripheral circulation and haemodynamic responses in patients admitted to a neurological intensive care unit.
Hypotheses:
Read more
H1-1: Passively administered PNF exercises have beneficial effects on peripheral circulation.
H2-1: Passively administered PNF exercises have beneficial effects on haemodynamic responses.
- Conditions
- Neurologic Disorder
- Being tested
- Proprioceptive Neuromuscular Facilitation Exercises, Passive Range of Motion Exercises
- Keywords
- Proprioceptive Neuromusculer Facilitation, Neurological Intensive Care, Haemodynamic Responses
- Medical subject headings
- Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive Neuromuscular Facilitation ExercisesOther
Also called PNF
The following PNF patterns will be applied to the upper extremity:
- flexion - abduction - external rotation → extension - adduction - internal rotation
- extension - abduction - internal rotation → flexion - adduction - external rotation
The following PNF patterns will be applied to the lower extremities:
- flexion - adduction - external rotation (with the knee extended) → extension - abduction - internal rotation
- extension - adduction - external rotation (with the knee extended) → flexion - abduction - internal rotation All exercises will be performed passively by the physiotherapist. Each movement will be performed in sets of 10-12 repetitions, with a 30-second rest period between sets.
Passive Range of Motion ExercisesOther
Also called PROM
Exercises for the upper extremities:
- shoulder flexion - extension
- shoulder abduction - adduction
- shoulder internal - external rotation
- elbow flexion - extension
- wrist flexion - extension
- finger flexion - extension
Exercises for the lower extremities:
- hip flexion - extension
- hip abduction - adduction
- hip internal - external rotation
- knee flexion - extension
- ankle dorsiflexion - plantar flexion All exercises will be performed passively by the physiotherapist. Each movement will be performed in sets of 10-12 repetitions, with a 30-second rest period between sets.
| Study group | Role | What they receive |
|---|---|---|
| PNF Group | Experimental | Patients in the PNF group will undergo proprioceptive neuromuscular facilitation (PNF) exercises. The exercises will be performed with patients in the supine position and the head elevated by 30°. Receives: Other: Proprioceptive Neuromuscular Facilitation Exercises |
| Control Group | Sham comparator | Patients in the control group will undergo passive range of motion (PROM) exercises in the same position. Receives: Other: Passive Range of Motion Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle-Brachial İndex
Systolic blood pressure will be measured at the brachial artery (upper limb) and the posterior tibial or dorsalis pedis artery (lower limb) using a Hadesco ES-101EX Doppler device, with patients in a supine resting position. The cuff will be placed at mid-arm and above the malleolus. It will be inflated until the pulse disappears and deflated slowly; the first reappearance of the pulse will be recorded as systolic pressure.
Measurements will be taken in order: same-side arm, same-side leg, opposite leg, and opposite arm. The ankle-brachial index will be calculated as the ratio of the highest lower limb systolic pressure to the highest upper limb systolic pressure.
Measured: Baseline and five or ten minutes after exercise
Heart Rate
Heart rate will be recorded as beats per minute and breaths per minute, respectively, based on data obtained from the patient monitor. Measurement will be taken whilst patients are in the supine position and at rest.
Measured: Baseline and five or ten minutes after exercise
Systolic blood pressure and diastolic blood pressure
Systolic and diastolic blood pressure measurements will be taken from the patient's upper extremity using an appropriately sized cuff and recorded in millimetres of mercury (mmHg). Measurement will be taken whilst patients are in the supine position and at rest.
Measured: Baseline and five or ten minutes after exercise
Respiratory rate
respiratory rate will be recorded as beats per minute and breaths per minute, respectively, based on data obtained from the patient monitor. Measurement will be taken whilst patients are in the supine position and at rest.
Measured: Baseline and five or ten minutes after exercise
Peripheral oxygen saturation (SpO₂)
Peripheral oxygen saturation (SpO₂) will be measured using a pulse oximeter. Measurement will be taken whilst patients are in the supine position and at rest.
Measured: Baseline and five or ten minutes after exercise
Secondary outcomes (3)
Rate Pressure Product
Rate Pressure Product is calculated by dividing the product of heart rate and systolic blood pressure by 1,000
Measured: Baseline and five or ten minutes after exercise
Quadriceps circumference measurement
Measurements will be taken whilst patients are in the supine position or, where appropriate, in a seated position. During the measurement, a non-elastic tape measure will be used to measure the circumference at the widest part of the thigh. The tape measure will be placed parallel to the thigh circumference, and the measurement result will be recorded in centimetres (cm).
To enhance the reliability of the measurement, two separate measurements will be taken for each patient, and the average of the obtained values will be used in the analyses.
Measured: Baseline and five or ten minutes after exercise
Oxford Acute Severity of Illness Score
Oxford Acute Severity of Illness Score comprises a total of 10 parameters: age, heart rate, mean arterial pressure, respiratory rate, body temperature, Glasgow Coma Scale, urine output, mechanical ventilation status, length of stay in intensive care, and the presence of elective surgery. Each parameter is assessed according to specific score ranges, and the total score indicates the severity of the illness. Higher scores indicate a higher risk of mortality.
Measured: Baseline and five or ten minutes after exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start15 May 2026 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurologic DisorderStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- two groups with a conventional therapy control group.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alp Ozel, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524790
- Sponsor's protocol ID
- AIBU-FTR-BS-002
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Proprioceptive Neuromuscular Facilitation on the Ankle-Brachial Index and Haemodynamic Responses in Patients in a Neurological Intensive Care Unit: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07524790
- Acronym / sponsor ID
- AIBU-FTR-BS-002
- Conditions
- Neurologic Disorder
- Keywords
- Proprioceptive Neuromusculer Facilitation, Neurological Intensive Care, Haemodynamic Responses
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 13 Apr 2026 (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.
Although there are studies examining the effect of actively performed PNF exercises on haemodynamic responses in intensive care patients and healthy individuals, there are no studies investigating their effect on circulation and haemodynamic responses in unconscious patients. Therefore, this study was designed to investigate the acute effects of proprioceptive neuromuscular facilitation (PNF) exercises on peripheral circulation and haemodynamic responses in patients admitted to a neurological intensive care unit.
Hypotheses:
H1-1: Passively administered PNF exercises have beneficial effects on peripheral circulation.
H2-1: Passively administered PNF exercises have beneficial effects on haemodynamic responses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two groups with a conventional therapy control group.
| Arm | Type | Receives |
|---|---|---|
| PNF Group | Experimental | Other: Proprioceptive Neuromuscular Facilitation ExercisesPatients in the PNF group will undergo proprioceptive neuromuscular facilitation (PNF) exercises. The exercises will be performed with patients in the supine position and the head elevated by 30°. |
| Control Group | Sham comparator | Other: Passive Range of Motion ExercisesPatients in the control group will undergo passive range of motion (PROM) exercises in the same position. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients being monitored in the neurology intensive care unit
- Aged 18 years or over
- Haemodynamically stable
- No orthopaedic condition preventing the performance of passive joint movements in the upper and lower limbs
- A signed informed consent form from a patient's next of relative for participation in the study
Key exclusion criteria (5 listed)
- Presence of haemodynamic instability
- Fractures, contractures or serious orthopaedic conditions in the upper or lower limbs that restrict movement
- Diagnosis or suspicion of deep vein thrombosis
- Severe peripheral arterial disease
- Serious cardiac arrhythmia that may prevent exercise
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 |
|---|---|---|
| Proprioceptive Neuromuscular Facilitation ExercisesAlso: PNFThe following PNF patterns will be applied to the upper extremity: * flexion - abduction - external rotation → extension - adduction - internal rotation * extension - abduction - internal rotation → flexion - adduction - external rotation The following PNF patterns will be applied to the lower extremities: * flexion - adduction - external rotation (with the knee extended) → extension - abduction - internal rotation * extension - adduction - external rotation (with the knee extended) → flexion - abduction - internal rotation All exercises will be performed passively by the physiotherapist. Each movement will be performed in sets of 10-12 repetitions, with a 30-second rest period between sets. | Other | PNF Group |
| Passive Range of Motion ExercisesAlso: PROMExercises for the upper extremities: * shoulder flexion - extension * shoulder abduction - adduction * shoulder internal - external rotation * elbow flexion - extension * wrist flexion - extension * finger flexion - extension Exercises for the lower extremities: * hip flexion - extension * hip abduction - adduction * hip internal - external rotation * knee flexion - extension * ankle dorsiflexion - plantar flexion All exercises will be performed passively by the physiotherapist. Each movement will be performed in sets of 10-12 repetitions, with a 30-second rest period between sets. | Other | Control Group |
Primary outcome
Ankle-Brachial İndex
Time frame: Baseline and five or ten minutes after exercise
Systolic blood pressure will be measured at the brachial artery (upper limb) and the posterior tibial or dorsalis pedis artery (lower limb) using a Hadesco ES-101EX Doppler device, with patients in a supine resting position. The cuff will be placed at mid-arm and above the malleolus. It will be inflated until the pulse disappears and deflated slowly; the first reappearance of the pulse will be recorded as systolic pressure. Measurements will be taken in order: same-side arm, same-side leg, opposite leg, and opposite arm. The ankle-brachial index will be calculated as the ratio of the highest lower limb systolic pressure to the highest upper limb systolic pressure.
Heart Rate
Time frame: Baseline and five or ten minutes after exercise
Heart rate will be recorded as beats per minute and breaths per minute, respectively, based on data obtained from the patient monitor. Measurement will be taken whilst patients are in the supine position and at rest.
Systolic blood pressure and diastolic blood pressure
Time frame: Baseline and five or ten minutes after exercise
Systolic and diastolic blood pressure measurements will be taken from the patient's upper extremity using an appropriately sized cuff and recorded in millimetres of mercury (mmHg). Measurement will be taken whilst patients are in the supine position and at rest.
Respiratory rate
Time frame: Baseline and five or ten minutes after exercise
respiratory rate will be recorded as beats per minute and breaths per minute, respectively, based on data obtained from the patient monitor. Measurement will be taken whilst patients are in the supine position and at rest.
Peripheral oxygen saturation (SpO₂)
Time frame: Baseline and five or ten minutes after exercise
Peripheral oxygen saturation (SpO₂) will be measured using a pulse oximeter. Measurement will be taken whilst patients are in the supine position and at rest.
3 secondary outcomes
Rate Pressure Product
Time frame: Baseline and five or ten minutes after exercise
Quadriceps circumference measurement
Time frame: Baseline and five or ten minutes after exercise
Oxford Acute Severity of Illness Score
Time frame: Baseline and five or ten minutes after exercise
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive Neuromuscular Facilitation Exercises and Passive Range of Motion Exercises in people with Neurologic Disorder, run by Abant Izzet Baysal University.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Ankle-Brachial İndex (time frame: Baseline and five or ten minutes after exercise). The study lists 5 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 13 Apr 2026.