StrokeNCT07853859
Acute Effects of Physiotherapy Interventions on Biceps Brachii Muscle Tissue Perfusion After Stroke
A study testing Proprioceptive Neuromuscular Facilitation (PNF), Bobath Concept and Virtual Reality (VR)-Based Intervention in people with Stroke, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate the acute effects of proprioceptive neuromuscular facilitation (PNF), the Bobath concept, and virtual reality (VR)-based interventions on biceps brachii tissue perfusion in individuals with chronic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Proprioceptive Neuromuscular Facilitation (PNF), Bobath Concept and Virtual Reality (VR)-Based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Sep 2024to 8 Apr 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Chronic phase of stroke
- Mini-Mental State Examination score ≥ 24
- Modified Ashworth Scale score ≥1
- Brunnstrom stage ≥3
Who cannot join
- Presence of another neurological disorder
- Cardiovascular, vestibular, metabolic, or orthopedic conditions severe enough to limit participation
- Inability to sit in a chair with back support
- Use of eyeglasses for visual correction without the option of wearing contact lenses
- Onset of symptoms of cybersickness or any discomfort preventing participation in the exercise during the procedure.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Bakircay University Physiotherapy and Rehabilitation Application and Research Center
Çiğli, İzmir, 35620
About this study
Official title: Investigation of the Acute Effects of Different Physiotherapy Applications on Biceps Brachii Muscle Tissue Perfusion in Individuals With Stroke
This study aimed to investigate the acute effects of proprioceptive neuromuscular facilitation (PNF), the Bobath concept, and virtual reality (VR)-based interventions on biceps brachii tissue perfusion in individuals with chronic stroke. In this randomized crossover study, participants received all three physiotherapy interventions in a randomized order. Each intervention lasted 10 minutes. Biceps brachii muscle oxygenation and local blood volume responses were assessed using near-infrared spectroscopy (NIRS) before, during, and after each intervention.
Read the detailed description
Muscle tissue responses were assessed using wearable near-infrared spectroscopy (NIRS) over the affected biceps brachii (BB). BB muscle tissue oxygen saturation (SmO₂) and total hemoglobin (tHb) were used to assess local muscle oxygenation and local blood-volume responses, respectively. The NIRS sensor was positioned over the medial aspect of the affected BB. SmO₂ and tHb were recorded for 2 minutes immediately before each intervention, continuously during the 10-minute intervention, and for 2 minutes immediately after each intervention.
- Conditions
- Stroke
- Being tested
- Proprioceptive Neuromuscular Facilitation (PNF), Bobath Concept, Virtual Reality (VR)-Based Intervention
- Keywords
- Chronic Stroke, Spasticity, Biceps Brachii, Near-Infrared Spectroscopy, Muscle Oxygenation, Tissue Perfusion, Proprioceptive Neuromuscular Facilitation, Bobath Concept, Virtual Reality
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive Neuromuscular Facilitation (PNF)Behavioural
A 10-minute PNF intervention was applied to the affected upper extremity in the supine position. Rhythmic initiation was followed by half- and full-pattern techniques. Biceps brachii inhibition and triceps brachii facilitation were performed mainly using an extension-abduction-internal rotation pattern with elbow extension. Repeated stretch and slow opposing movements were used for triceps facilitation. Pectoral inhibition in a flexion-abduction-external rotation pattern was added when required.
Bobath ConceptBehavioural
A 10-minute Bobath concept intervention was applied primarily in the supine and hook-lying positions. The intervention included latissimus dorsi elongation, scapular depression, supine arm elevation, elbow control, functional elbow control, midline approximation when tolerated, and bilateral elbow flexion-extension with the hands clasped. Light resistance, repeated contractions, or active-assistive movements were used according to muscle strength and active range of motion.
Virtual Reality (VR)-Based InterventionBehavioural
A 10-minute VR-based upper-extremity intervention was performed in a seated position with back support. Following orientation and device-use training, participants played a beginner-level Fruit Ninja game continuously for 10 minutes. The game was selected because its movements resembled PNF diagonals and were compatible with Bobath concept upper-extremity facilitation.
| Study group | Role | What they receive |
|---|---|---|
| A. PNF - Bobath - VR | Experimental | Participants received PNF first, followed by the Bobath concept, and then the VR-based intervention, with 10-minute rest intervals between the interventions. Receives: Behavioral: Proprioceptive Neuromuscular Facilitation (PNF); Behavioral: Bobath Concept; Behavioral: Virtual Reality (VR)-Based Intervention |
| B. PNF - VR - Bobath | Experimental | Participants received PNF first, followed by the VR-based intervention, and then the Bobath concept, with 10-minute rest intervals between the interventions. Receives: Behavioral: Proprioceptive Neuromuscular Facilitation (PNF); Behavioral: Bobath Concept; Behavioral: Virtual Reality (VR)-Based Intervention |
| C. Bobath - PNF - VR | Experimental | Participants received the Bobath concept first, followed by the PNF, and then the VR-based intervention, with 10-minute rest intervals between the interventions. Receives: Behavioral: Proprioceptive Neuromuscular Facilitation (PNF); Behavioral: Bobath Concept; Behavioral: Virtual Reality (VR)-Based Intervention |
| D. Bobath - VR - PNF | Experimental | Participants received the Bobath concept first, followed by the VR-based intervention, and then the PNF, with 10-minute rest intervals between the interventions. Receives: Behavioral: Proprioceptive Neuromuscular Facilitation (PNF); Behavioral: Bobath Concept; Behavioral: Virtual Reality (VR)-Based Intervention |
| E. VR - PNF - Bobath | Experimental | Participants received the VR-based intervention first, followed by the PNF, and then the Bobath concept, with 10-minute rest intervals between the interventions. Receives: Behavioral: Proprioceptive Neuromuscular Facilitation (PNF); Behavioral: Bobath Concept; Behavioral: Virtual Reality (VR)-Based Intervention |
| F. VR - Bobath - PNF | Experimental | Participants received the VR-based intervention first, followed by the Bobath concept, and then the PNF, with 10-minute rest intervals between the interventions. Receives: Behavioral: Proprioceptive Neuromuscular Facilitation (PNF); Behavioral: Bobath Concept; Behavioral: Virtual Reality (VR)-Based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Biceps Brachii Skeletal Muscle Oxygen Saturation (ΔSmO₂)
Change in SmO₂ was calculated as the post-intervention value minus the pre-intervention value for the affected biceps brachii.
Measured: From the 2-minute period immediately before to the 2-minute period immediately after each 10-minute intervention.
Mean Biceps Brachii Skeletal Muscle Oxygen Saturation (SmO₂) During Intervention
Skeletal muscle oxygen saturation (SmO₂) of the affected biceps brachii was continuously measured using wearable near-infrared spectroscopy (NIRS). The mean SmO₂ value during each intervention was calculated.
Measured: During each 10-minute intervention.
Mean Biceps Brachii Total Hemoglobin (tHb) During Intervention
Total hemoglobin (tHb) of the affected biceps brachii was continuously measured using wearable NIRS as an indicator of local blood-volume response. The mean tHb value during each intervention was calculated.
Measured: During each 10-minute intervention.
Change in Biceps Brachii Total Hemoglobin (ΔtHb)
Change in tHb was calculated as the post-intervention value minus the pre-intervention value for the affected biceps brachii.
Measured: From the 2-minute period immediately before to the 2-minute period immediately after each 10-minute intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start19 Sep 2024
- Primary completion8 Apr 2026
- Study completion8 Apr 2026
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Proprioceptive neuromuscular facilitation (PNF), the Bobath concept, and virtual reality (VR)-based interventions were administered to all participants, with rest intervals between them. The order of administration for these three interventions was randomized to allow for a within-subject comparison of acute muscle oxygenation and local blood volume responses.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülbin Ergin, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853859
- Sponsor's protocol ID
- 1019
- Other IDs
- BBAP.2023.10
- Status last verified
- Sep 2026
- First submitted
- 26 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study records may be reviewed by authorized ethics or regulatory bodies when required. However, individual participant data are not planned to be shared with other researchers unless appropriate ethical and institutional approvals are obtained.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Acute Effects of Different Physiotherapy Applications on Biceps Brachii Muscle Tissue Perfusion in Individuals With Stroke
- ClinicalTrials.gov ID
- NCT07853859
- Acronym / sponsor ID
- 1019
- Conditions
- Stroke
- Keywords
- Chronic Stroke, Spasticity, Biceps Brachii, Near-Infrared Spectroscopy, Muscle Oxygenation, Tissue Perfusion, Proprioceptive Neuromuscular Facilitation, Bobath Concept
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- 8 Apr 2026 (actual)
- Study completion
- 8 Apr 2026 (actual)
- First posted
- 2 Oct 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.
This study aimed to investigate the acute effects of proprioceptive neuromuscular facilitation (PNF), the Bobath concept, and virtual reality (VR)-based interventions on biceps brachii tissue perfusion in individuals with chronic stroke. In this randomized crossover study, participants received all three physiotherapy interventions in a randomized order. Each intervention lasted 10 minutes. Biceps brachii muscle oxygenation and local blood volume responses were assessed using near-infrared spectroscopy (NIRS) before, during, and after each intervention.
Detailed description
Muscle tissue responses were assessed using wearable near-infrared spectroscopy (NIRS) over the affected biceps brachii (BB). BB muscle tissue oxygen saturation (SmO₂) and total hemoglobin (tHb) were used to assess local muscle oxygenation and local blood-volume responses, respectively. The NIRS sensor was positioned over the medial aspect of the affected BB. SmO₂ and tHb were recorded for 2 minutes immediately before each intervention, continuously during the 10-minute intervention, and for 2 minutes immediately after each intervention.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Proprioceptive neuromuscular facilitation (PNF), the Bobath concept, and virtual reality (VR)-based interventions were administered to all participants, with rest intervals between them. The order of administration for these three interventions was randomized to allow for a within-subject comparison of acute muscle oxygenation and local blood volume responses.
| Arm | Type | Receives |
|---|---|---|
| A. PNF - Bobath - VR | Experimental | Behavioral: Proprioceptive Neuromuscular Facilitation (PNF), Behavioral: Bobath Concept, Behavioral: Virtual Reality (VR)-Based InterventionParticipants received PNF first, followed by the Bobath concept, and then the VR-based intervention, with 10-minute rest intervals between the interventions. |
| B. PNF - VR - Bobath | Experimental | Behavioral: Proprioceptive Neuromuscular Facilitation (PNF), Behavioral: Bobath Concept, Behavioral: Virtual Reality (VR)-Based InterventionParticipants received PNF first, followed by the VR-based intervention, and then the Bobath concept, with 10-minute rest intervals between the interventions. |
| C. Bobath - PNF - VR | Experimental | Behavioral: Proprioceptive Neuromuscular Facilitation (PNF), Behavioral: Bobath Concept, Behavioral: Virtual Reality (VR)-Based InterventionParticipants received the Bobath concept first, followed by the PNF, and then the VR-based intervention, with 10-minute rest intervals between the interventions. |
| D. Bobath - VR - PNF | Experimental | Behavioral: Proprioceptive Neuromuscular Facilitation (PNF), Behavioral: Bobath Concept, Behavioral: Virtual Reality (VR)-Based InterventionParticipants received the Bobath concept first, followed by the VR-based intervention, and then the PNF, with 10-minute rest intervals between the interventions. |
| E. VR - PNF - Bobath | Experimental | Behavioral: Proprioceptive Neuromuscular Facilitation (PNF), Behavioral: Bobath Concept, Behavioral: Virtual Reality (VR)-Based InterventionParticipants received the VR-based intervention first, followed by the PNF, and then the Bobath concept, with 10-minute rest intervals between the interventions. |
| F. VR - Bobath - PNF | Experimental | Behavioral: Proprioceptive Neuromuscular Facilitation (PNF), Behavioral: Bobath Concept, Behavioral: Virtual Reality (VR)-Based InterventionParticipants received the VR-based intervention first, followed by the Bobath concept, and then the PNF, with 10-minute rest intervals between the interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- Chronic phase of stroke
- Mini-Mental State Examination score ≥ 24
- Modified Ashworth Scale score ≥1
- Brunnstrom stage ≥3
Key exclusion criteria (5 listed)
- Presence of another neurological disorder
- Cardiovascular, vestibular, metabolic, or orthopedic conditions severe enough to limit participation
- Inability to sit in a chair with back support
- Use of eyeglasses for visual correction without the option of wearing contact lenses
- Onset of symptoms of cybersickness or any discomfort preventing participation in the exercise during the procedure.
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 (PNF)A 10-minute PNF intervention was applied to the affected upper extremity in the supine position. Rhythmic initiation was followed by half- and full-pattern techniques. Biceps brachii inhibition and triceps brachii facilitation were performed mainly using an extension-abduction-internal rotation pattern with elbow extension. Repeated stretch and slow opposing movements were used for triceps facilitation. Pectoral inhibition in a flexion-abduction-external rotation pattern was added when required. | Behavioural | A. PNF - Bobath - VR, B. PNF - VR - Bobath, C. Bobath - PNF - VR, D. Bobath - VR - PNF, E. VR - PNF - Bobath, F. VR - Bobath - PNF |
| Bobath ConceptA 10-minute Bobath concept intervention was applied primarily in the supine and hook-lying positions. The intervention included latissimus dorsi elongation, scapular depression, supine arm elevation, elbow control, functional elbow control, midline approximation when tolerated, and bilateral elbow flexion-extension with the hands clasped. Light resistance, repeated contractions, or active-assistive movements were used according to muscle strength and active range of motion. | Behavioural | A. PNF - Bobath - VR, B. PNF - VR - Bobath, C. Bobath - PNF - VR, D. Bobath - VR - PNF, E. VR - PNF - Bobath, F. VR - Bobath - PNF |
| Virtual Reality (VR)-Based InterventionA 10-minute VR-based upper-extremity intervention was performed in a seated position with back support. Following orientation and device-use training, participants played a beginner-level Fruit Ninja game continuously for 10 minutes. The game was selected because its movements resembled PNF diagonals and were compatible with Bobath concept upper-extremity facilitation. | Behavioural | A. PNF - Bobath - VR, B. PNF - VR - Bobath, C. Bobath - PNF - VR, D. Bobath - VR - PNF, E. VR - PNF - Bobath, F. VR - Bobath - PNF |
Primary outcome
Change in Biceps Brachii Skeletal Muscle Oxygen Saturation (ΔSmO₂)
Time frame: From the 2-minute period immediately before to the 2-minute period immediately after each 10-minute intervention.
Change in SmO₂ was calculated as the post-intervention value minus the pre-intervention value for the affected biceps brachii.
Mean Biceps Brachii Skeletal Muscle Oxygen Saturation (SmO₂) During Intervention
Time frame: During each 10-minute intervention.
Skeletal muscle oxygen saturation (SmO₂) of the affected biceps brachii was continuously measured using wearable near-infrared spectroscopy (NIRS). The mean SmO₂ value during each intervention was calculated.
Mean Biceps Brachii Total Hemoglobin (tHb) During Intervention
Time frame: During each 10-minute intervention.
Total hemoglobin (tHb) of the affected biceps brachii was continuously measured using wearable NIRS as an indicator of local blood-volume response. The mean tHb value during each intervention was calculated.
Change in Biceps Brachii Total Hemoglobin (ΔtHb)
Time frame: From the 2-minute period immediately before to the 2-minute period immediately after each 10-minute intervention.
Change in tHb was calculated as the post-intervention value minus the pre-intervention value for the affected biceps brachii.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No. Study records may be reviewed by authorized ethics or regulatory bodies when required. However, individual participant data are not planned to be shared with other researchers unless appropriate ethical and institutional approvals are obtained.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive Neuromuscular Facilitation (PNF), Bobath Concept and Virtual Reality (VR)-Based Intervention in people with Stroke, run by Izmir Bakircay 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 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: finished, as of the sponsor's last update on 2 Oct 2026. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Biceps Brachii Skeletal Muscle Oxygen Saturation (ΔSmO₂) (time frame: From the 2-minute period immediately before to the 2-minute period immediately after each 10-minute intervention.). The study lists 4 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 2 Oct 2026.