Effect of BFR Rehab After Achilles Tendon Rupture

Achilles Tendon Rupture Clinical Trial

Official title:

Effect of Blood Flow Restriction (BFR) Rehabilitation After Achilles Tendon Rupture Reconstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06254794
• Other study ID #: Pro00019305
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2018
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: The Methodist Hospital Research Institute
• Contact: Haley Goble
• Phone: 713.441.3930
• Email: hmgoble[@]houstonmethodist.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if blood flow restriction therapy after Achilles tendon rupture reconstruction decreases post-operative calf atrophy, improves reported outcomes, and ultimately decreases return to play time.

Description:

The purpose of this research study is to determine if the use of Blood Flow Restriction, BFR, therapy in addition to standard physical therapy (PT) for post-Achilles tendon rupture reconstruction will decrease post-operative muscle atrophy (loss of muscle), increases dorsal and planar ankle flexion (range of motion), increase strength, and ultimately decrease return to play time for the BFR therapy group as compared to the control group.

Participants in this study will be randomly divided into either BFR group that will receive BFR therapy in addition to standard physical therapy protocol post-operatively or the control group which will undergo the standard PT protocol. All participants will complete full body composition scans (DEXA) and questionnaires before surgery, prior to physical therapy (three weeks post-op), eight weeks post-op, and 16 weeks post-op. Subjective and objective measures will be taken at physical therapy eight weeks and 16 weeks post-operatively.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 19
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Achilles Rupture confirmed by MRI or Thompson Test

• Adult

• Receiving Percutaneous Achilles Repair System (PARS) or open repair

• Proposed PT with Methodist Location

Exclusion Criteria:

• Obesity (BMI>35)

• Diabetes

• Cardiovascular, renal, liver or pulmonary disease

• Active infections

• Cancer (current or treated within the past 2 years) or coagulation disorder

• Physically unable to participate in the intervention

• Unable to complete a minimum of 85% of the assigned rehabilitation sessions

• Less than 18 years of age

• Pregnant

Related Conditions & MeSH terms

• Achilles Tendon Rupture
• Rupture

Intervention

Device:
• Blood flow restriction with Delfi Personalized Tourniquet System (PTS)
Standard of care physical therapy exercises with the use of the Delfi PTS cuff

Other:
• Physical therapy
Standard of care physical therapy exercises

Locations

Country	Name	City	State
United States	Houston Methodist Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The Methodist Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle mass preservation	Lean mass for lower extremity measured in kilograms (kg) using Dual-Energy-Xray-Absorptiometry (DEXA).	pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op
Primary	Bone density preservation	Bone mineral content measured in grams using Dual-Energy-Xray-Absorptiometry (DEXA).	pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op
Primary	Improve patient reported outcomes (Physical activity)	Digital RedCap survey tool sends Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function survey which consists of questions about their physical health and patient responds with Excellent, Very Good, Good, Fair or poor. Using healthmeasures.net, responses are converted to T-scores based on the general population. The highest the T-scores, the better physical health the patient has.	pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op
Primary	Improve patient reported outcomes (Pain)	Digital RedCap survey tool sends Pain Visual Analog Scale asking patients to rate their pain from 0 (no pain) to 100 (worst pain possible).	pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op
Primary	Improve patient reported outcomes (Achilles tendon survey)	Digital RedCap survey tool sends Achilles Tendon Rupture Score (ATRS) survey. This survey asks 10 questions where the patient answers from 0=major limitation to 10=No limitations. High scores point to better physical activity.	pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op
Primary	Change in range of motion	Physical therapy will do functional assessments including: leg squat depth, Y balance anterior, y balance posteromedial, y balance posterolateral and measure in centimeters (cm). The measurements will be taken at each physical therapy appointment and compared at the end of the study.	Starting 4 weeks post op, patient will go to physical therapy twice a week until week 16.
Primary	Change in single heel raise repetitions	Physical therapy will count how many heel raises can be done at each timepoint.	Starting 4 weeks post op, patient will go to physical therapy twice a week until week 16.