- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07307339
The Acute Effects of Blood Flow Restriction on Ankle Muscle Reaction Time and Proprioception in Healthy Individuals
December 14, 2025 updated by: Melike Tugran, Uludag University
his randomized controlled crossover study aims to investigate the acute effects of lower limb blood flow restriction (BFR) on ankle joint proprioception, postural control, and muscle activation in healthy adults.
Each participant will complete test sessions under BFR (60% individualized arterial occlusion pressure) and control (20 mmHg sham) conditions.
Outcome measures include joint position sense, kinesthesia, static and dynamic balance performance, and electromyographic (EMG) activity and reaction times of selected lower limb tibialis anterior and peroneus longus muscles.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Lateral ankle sprains are among the most common musculoskeletal injuries and may lead to chronic ankle instability (CAI), partly due to impaired proprioception and neuromuscular control.
Blood flow restriction (BFR) training is widely used to augment muscular adaptations with low external loads; however, its acute effects on joint proprioception and sensorimotor control, particularly at the ankle joint, remain unclear and may be detrimental under certain conditions.
This randomized controlled crossover trial will examine the effects of a single-session lower limb BFR application on ankle joint position sense, kinesthesia, static and dynamic balance, and EMG-based reaction time and activity of lower limb muscles in healthy adults.
Participants aged 18-40 years without recent ankle sprain, neuromuscular, cardiovascular, or thromboembolic disease will undergo standardized proprioception tests using an isokinetic dynamometer, static balance tests on a force platform, Y-balance test, and inversion simulation platform assessments under BFR (60% arterial occlusion pressure) and low-pressure control (20 mmHg) conditions.
Individual arterial occlusion pressure (AOP) will be determined using Doppler ultrasound, and BFR will be applied with a pneumatic cuff at the most proximal thigh.
All measurements will be performed on the dominant lower limb with sessions scheduled at the same time of day to minimize circadian variability.
The primary hypothesis is that acute lower limb BFR will worsen ankle joint proprioception and sensorimotor control compared with the control condition, potentially indicating a transient increase in injury risk during BFR-assisted activities.
Study Type
Interventional
Enrollment (Estimated)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bursa, Turkey (Türkiye), 16059
- Uludag University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Aged between 18 and 40 years
- No known neuromuscular or cardiovascular disease
Exclusion Criteria:
- History or presence of cardiac, coronary artery, or peripheral arterial disease
- Presence or history of varicose veins, hypertension, diabetes mellitus, or pulmonary disease
- History of pulmonary embolism or deep vein thrombosis
- Use of medications affecting the central nervous or cardiovascular systems
- Use of oral contraceptives or anticoagulants
- Pregnancy
- Open wounds or significant scar tissue at the cuff application site
- History of lower extremity musculoskeletal injury or surgery
- Any neurological, vascular, or systemic condition that may interfere with test performance
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Blood Flow Restriction
Participants perform balance/proprioception tests under lower limb blood flow restriction at % 60 AOP.
|
Arm Description: Participants perform balance/proprioception tests under lower limb blood flow restriction at % 60 AOP.
|
|
Sham Comparator: Sham BFR
Sham BFR Description: Participants perform the same tests with sham(20 mmHg) blood flow restriction
|
Sham BFR Description: Participants perform the same tests with sham(20 mmHg) blood flow restriction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Ankle Joint Position Sense Error (degrees)
Time Frame: day 1 and day 2
|
Absolute error (degrees) between target and reproduced angles during passive and active joint position sense tests in inversion and plantar flexion, measured with an isokinetic dynamometer.
|
day 1 and day 2
|
|
Static Balance Performance
Time Frame: day 3
|
Center of pressure path length (mm) in single-leg and tandem stance with eyes open/closed on force platform (HUR SmartBalance).
|
day 3
|
|
Change in Kinesthesia Threshold (degrees)
Time Frame: day 1 and day 2
|
Minimal angular displacement (degrees) at which movement is first perceived in inversion and plantarflexion.
|
day 1 and day 2
|
|
Static balance performance
Time Frame: day 3
|
sway velocity (mm/s) in single-leg and tandem stance with eyes open/closed on force platform (HUR SmartBalance).
|
day 3
|
|
static balance performance
Time Frame: day 3
|
sway area (mm^2) in single-leg and tandem stance with eyes open/closed on force platform (HUR SmartBalance).
|
day 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Y-Balance Test Reach Distances (cm)
Time Frame: day 4
|
Anterior, posteromedial and posterolateral reach distances of the tested limb.
|
day 4
|
|
Peroneus Longus and Tibialis Anterior Reaction Time (ms)
Time Frame: day 4
|
Time from onset of platform-induced inversion to EMG activation exceeding 2× resting activity.
|
day 4
|
|
Lower Limb EMG Activity (%MVIC)
Time Frame: day 4
|
Mean EMG amplitude normalized to maximal voluntary isometric contraction values.
|
day 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: ufuk sekir, Department of Sports Medicine, Bursa Uludağ University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2025
Primary Completion (Estimated)
December 30, 2025
Study Completion (Estimated)
January 10, 2026
Study Registration Dates
First Submitted
November 14, 2025
First Submitted That Met QC Criteria
December 14, 2025
First Posted (Actual)
December 29, 2025
Study Record Updates
Last Update Posted (Actual)
December 29, 2025
Last Update Submitted That Met QC Criteria
December 14, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-15/31
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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