NCT07853859

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 19, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 2, 2026

Completed
Last Updated

October 2, 2026

Status Verified

September 1, 2026

Enrollment Period

1.6 years

First QC Date

September 26, 2026

Last Update Submit

September 26, 2026

Conditions

Keywords

Chronic StrokeSpasticityBiceps BrachiiNear-Infrared SpectroscopyMuscle OxygenationTissue PerfusionProprioceptive Neuromuscular FacilitationBobath ConceptVirtual Reality

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    From the 2-minute period immediately before to the 2-minute period immediately after each 10-minute intervention.

Study Arms (6)

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.

Behavioral: Proprioceptive Neuromuscular Facilitation (PNF)Behavioral: Bobath ConceptBehavioral: 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.

Behavioral: Proprioceptive Neuromuscular Facilitation (PNF)Behavioral: Bobath ConceptBehavioral: 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.

Behavioral: Proprioceptive Neuromuscular Facilitation (PNF)Behavioral: Bobath ConceptBehavioral: 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.

Behavioral: Proprioceptive Neuromuscular Facilitation (PNF)Behavioral: Bobath ConceptBehavioral: 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.

Behavioral: Proprioceptive Neuromuscular Facilitation (PNF)Behavioral: Bobath ConceptBehavioral: 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.

Behavioral: Proprioceptive Neuromuscular Facilitation (PNF)Behavioral: Bobath ConceptBehavioral: Virtual Reality (VR)-Based Intervention

Interventions

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.

A. PNF - Bobath - VRB. PNF - VR - BobathC. Bobath - PNF - VRD. Bobath - VR - PNFE. VR - PNF - BobathF. VR - Bobath - PNF
Bobath ConceptBEHAVIORAL

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.

A. PNF - Bobath - VRB. PNF - VR - BobathC. Bobath - PNF - VRD. Bobath - VR - PNFE. VR - PNF - BobathF. VR - Bobath - PNF

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.

A. PNF - Bobath - VRB. PNF - VR - BobathC. Bobath - PNF - VRD. Bobath - VR - PNFE. VR - PNF - BobathF. VR - Bobath - PNF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • Chronic phase of stroke
  • Mini-Mental State Examination score ≥ 24
  • Modified Ashworth Scale score ≥1
  • Brunnstrom stage ≥3

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Bakircay University Physiotherapy and Rehabilitation Application and Research Center

Çiğli, İzmir, 35620, Turkey (Türkiye)

Location

MeSH Terms

Conditions

StrokeMuscle Spasticity

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 26, 2026

First Posted

October 2, 2026

Study Start

September 19, 2024

Primary Completion

April 8, 2026

Study Completion

April 8, 2026

Last Updated

October 2, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

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.

Locations