Effect of BFR Rehab After Achilles Tendon Rupture
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood flow restriction with Delfi Personalized Tourniquet System (PTS), Physical therapy.
- Who it may be relevant to
- Registry conditions: Achilles Tendon Rupture. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Blood Flow Restriction (BFR) Rehabilitation After Achilles Tendon Rupture Reconstruction
Overview
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.
Detailed 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.
Interventions
- 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
Primary outcome measures
- Muscle mass preservation [Time frame: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op]
- Bone density preservation [Time frame: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op]
- Improve patient reported outcomes (Physical activity) [Time frame: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op]
- Improve patient reported outcomes (Pain) [Time frame: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op]
- Improve patient reported outcomes (Achilles tendon survey) [Time frame: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op]
- Change in range of motion [Time frame: Starting 4 weeks post op, patient will go to physical therapy twice a week until week 16.]
- Change in single heel raise repetitions [Time frame: Starting 4 weeks post op, patient will go to physical therapy twice a week until week 16.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Houston Methodist Hospital — Houston
Identifiers
NCT: NCT06254794 · Pro00019305