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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Blood Flow Restriction
Participants perform balance/proprioception tests under lower limb blood flow restriction at % 60 AOP.
Other: Blood Flow Restriction
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
Other: Sham 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Uludag University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 10, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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