NCT07307339

Brief Summary

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.

Trial Health

55
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 29, 2025

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2026

Completed
Last Updated

December 29, 2025

Status Verified

November 1, 2025

Enrollment Period

4 months

First QC Date

November 14, 2025

Last Update Submit

December 14, 2025

Conditions

Keywords

ankleproprioceptionblood flow restriction

Outcome Measures

Primary Outcomes (5)

  • Change in Ankle Joint Position Sense Error (degrees)

    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

    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)

    Minimal angular displacement (degrees) at which movement is first perceived in inversion and plantarflexion.

    day 1 and day 2

  • Static balance performance

    sway velocity (mm/s) in single-leg and tandem stance with eyes open/closed on force platform (HUR SmartBalance).

    day 3

  • static balance performance

    sway area (mm\^2) in single-leg and tandem stance with eyes open/closed on force platform (HUR SmartBalance).

    day 3

Secondary Outcomes (3)

  • Y-Balance Test Reach Distances (cm)

    day 4

  • Peroneus Longus and Tibialis Anterior Reaction Time (ms)

    day 4

  • Lower Limb EMG Activity (%MVIC)

    day 4

Study Arms (2)

Blood Flow Restriction

EXPERIMENTAL

Participants perform balance/proprioception tests under lower limb blood flow restriction at % 60 AOP.

Other: Blood Flow Restriction

Sham BFR

SHAM COMPARATOR

Sham BFR Description: Participants perform the same tests with sham(20 mmHg) blood flow restriction

Other: Sham Blood Flow Restriction

Interventions

Arm Description: Participants perform balance/proprioception tests under lower limb blood flow restriction at % 60 AOP.

Blood Flow Restriction

Sham BFR Description: Participants perform the same tests with sham(20 mmHg) blood flow restriction

Sham BFR

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged between 18 and 40 years
  • No known neuromuscular or cardiovascular disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uludag University

Bursa, 16059, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Blood Flow Restriction Therapy

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • ufuk sekir

    Department of Sports Medicine, Bursa Uludağ University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Arm 1: Experimental - Blood Flow Restriction Participants perform balance and proprioception tests under lower-limb blood flow restriction at 60% arterial occlusion pressure. Arm 2: Sham Comparator - Sham Blood Flow Restriction Participants perform the same balance and proprioception tests with sham blood flow restriction at 20 mmHg. This is a randomized crossover study, and all participants complete both conditions in a randomized order.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 14, 2025

First Posted

December 29, 2025

Study Start

September 1, 2025

Primary Completion

December 30, 2025

Study Completion

January 10, 2026

Last Updated

December 29, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations