NCT07451210

Brief Summary

The goal of this single blinded clinical trial is to investigate blood flow restriction (BFR) for rehabilitation of patients after ankle ligament reconstruction surgery. Outcome measures will be compared between the standard of care (SoC) and BFR groups at the end of the study intervention. Following standard surgical procedures, both groups will undergo physical therapy by a certified physical therapist for a minimum of 6 weeks. The SOC group will receive standard physical therapy without use of BFR. The BFR group will receive physical therapy with BFR. Outcome measures of interest will be taken at the start of physical therapy (time 0) and at the end of physical therapy (minimum of 6 weeks of PT) for both groups. Outcome measures of interest include:

  • muscle atrophy;
  • ankle function;
  • fatigability/manual muscle testing;
  • pain scores;
  • cardiovascular effects (heart rate, blood pressure).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
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 Progress12%
Mar 2026Dec 2027

First Submitted

Initial submission to the registry

January 13, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

1.3 years

First QC Date

January 13, 2026

Last Update Submit

March 13, 2026

Conditions

Ankle ReconstructionBlood Flow Restriction TherapyPhysical Therapy

Keywords

ankle reconstructionphysical therapyblood flow restriction therapyBFR

Outcome Measures

Primary Outcomes (7)

  • Muscle atrophy measurement - gastrocnemius

    Measurement location: maximal circumference of the gastrocnemius muscle Unit: cm Range: varies by participant

    baseline/Visit 1 (28 days + 7 days post-op), Visit 2 (63-70 days post op), Visit 3 (optional - upon completion of PT)

  • Muscle atrophy measurement - quadriceps

    Measurement location: 10 cm and 20 cm above the superior aspect of the patella Unit: cm Range: varies by participant

    baseline/Visit 1 (28 days + 7 days post-op), Visit 2 (63-70 days post op), Visit 3 (optional - upon completion of PT)

  • Fatigability recovery using manual muscle testing (MMT)

    Measurement description: Manual muscle testing (MMT) will be used to evaluate plantar flexion fatigability with the ankle in a neutral position, unweighted. This will help determine the effectiveness of BFR therapy in restoring muscle fatigability compared to the standard of care. Score range: 5 - 10+ (higher score indicates better fatigability recovery)

    baseline/Visit 1 (28 days + 7 days post-op), Visit 2 (63-70 days post op), Visit 3 (optional - upon completion of PT)

  • Foot and Ankle Disability Index (FADI)

    Measurement description: Manual muscle testing (MMT) will be used to evaluate plantar flexion fatigability with the ankle in a neutral position, unweighted. This will help determine the effectiveness of BFR therapy in restoring muscle fatigability compared to the standard of care. Score range: 5 - 10+ (higher score indicates better fatigability recovery)

    baseline/Visit 1 (28 days + 7 days post-op), Visit 2 (63-70 days post op), Visit 3 (optional - upon completion of PT)

  • Pain Management - Visual analog scale

    Measurement description: Pain will be assessed using a visual analog scale (VAS), rated from 0-10, and recorded during the study visits to help evaluate the effectiveness of BFR therapy in reducing pain during rehabilitation. They will also be verbally asked during each therapy session to ensure subject comfort. Score range: 0 - 10 (higher score indicates higher levels of pain)

    baseline/Visit 1 (28 days + 7 days post-op), Visit 2 (63-70 days post op), Visit 3 (optional - upon completion of PT)

  • Cardiovascular impact - heart rate

    Measurement description: Resting heart rate will be measured u to determine if BFR therapy provides any incidental cardiovascular benefits. Measurement tool: automatic cuff (Omron Bronze, OMRON HEALTHCARE CO Kyoto, Japan) Range: varies by participant Units: beats per minute (bpm)

    baseline/Visit 1 (28 days + 7 days post-op), Visit 2 (63-70 days post op), Visit 3 (optional - upon completion of PT)

  • Cardiovascular impact - blood pressure

    Measurement description: Resting blood pressure will be measured u to determine if BFR therapy provides any incidental cardiovascular benefits. Measurement tool: automatic cuff (Omron Bronze, OMRON HEALTHCARE CO Kyoto, Japan) Range: varies by participant Units: systolic/diastolic in mmHg

    baseline/Visit 1 (28 days + 7 days post-op), Visit 2 (63-70 days post op), Visit 3 (optional - upon completion of PT)

Study Arms (2)

Standard of Care (SOC) group

NO INTERVENTION

standard course of physical therapy; no BFR

Blood flow restriction (BFR) group

EXPERIMENTAL

BFR device added during physical therapy

Device: blood flow restriction

Interventions

blood flow restrictionDEVICE

The intervention group will receive the standard of care PT performed with BFR on affected limb. The intervention group will be treated with a BFR Smarttools SmartCuffs versions 3.0 or higher. During the baseline visit, the device will be placed over the affected limb's greater trochanter and inflated to 60% of their limb occlusion pressure. This will be titrated up to 80% over the first week to ensure subject comfort. During the remaining physical therapy sessions, patients will perform exercises prescribed by a licensed t-PT to perform under occlusion with a load of 30% of the subjects estimated 1-rep max.

Also known as: BFR, Kaatsu
Blood flow restriction (BFR) group

Eligibility Criteria

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

You may qualify if:

  • Age 18-65 years.
  • Post ankle ligament reconstruction surgery (medial or lateral, with or without ankle scope).
  • Capability of paying for physical therapy or having insurance coverage for at least 6 weeks of therapy.

You may not qualify if:

  • Major cardiac or connective tissue disorders (e.g., Ehlers-Danlos syndrome, Marfan syndrome).
  • Autoimmune disorders.
  • History of stroke or deep vein thrombosis (DVT).
  • Bleeding or coagulation disorders.
  • Congenital or developmental musculoskeletal disorders (e.g., cerebral palsy, Parkinson's disease).
  • Pregnancy (current or planning to become pregnant in the next 4 months)
  • Malignancy (cancer).
  • Professional athletes.
  • Workers compensation insurance status as worker's compensation often does not cover the necessary duration of physical therapy (minimum of 4 weeks).
  • Be currently enrolled or have been enrolled in another interventional clinical research study within the past 30 days (at time of consent); or
  • Cognitively not able to consent or participate in research (dementia; severe developmental delay; language/communication limitations; brain injury; etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Physical Therapy Today (PTT)

Lubbock, Texas, 79407, United States

ACTIVE NOT RECRUITING

University Medical Center

Lubbock, Texas, 79415, United States

ACTIVE NOT RECRUITING

Northstar Surgery Center

Lubbock, Texas, 79416, United States

ACTIVE NOT RECRUITING

The Center for Orthopedic Surgery

Lubbock, Texas, 79416, United States

RECRUITING

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

RECRUITING

MeSH Terms

Interventions

Blood Flow Restriction Therapy

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Jerry Grimes, MD

    Texas Tech University Health Sciences Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenny Hudnall, MS BME

CONTACT

806-743-2260jennifer.hudnall@ttuhsc.edu

Evan Hernandez, MBA

CONTACT

806-743-4600Evan.J.Hernandez@ttuhsc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Following enrollment, subjects will be randomly assigned to either the intervention group (BFR therapy) or the control group (SOC). Patients will be randomized using sequentially numbered opaque sealed envelopes (SNOSE) with their treatment group and study ID number pre-assigned. These envelopes will contain the information regarding their randomization and will not be opened until after the patient is consented for the study. The subject's treatment group will be communicated to their t-PT, after they have conducted the first visits' measurements. The t-PT will not perform any data collection for the subjects they treat and will and will perform physical therapy for those patients.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single blinded (assessor); Cohort study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor, Department of Orthopaedic Surgery

Study Record Dates

First Submitted

January 13, 2026

First Posted

March 5, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(5)