Fracture of Foot
Conditions
Brief summary
The purpose of the study is to determine the role of blood flow restriction (BFR) + neuromuscular electrical stimulation (NMES) in improving post-operative physical therapy and recovery after ankle fracture surgery. We expect to see improved muscle strength, less muscle wasting, and improved functional recovery after surgery when making these additions to routine post-operative (postop) physical therapy protocols.
Detailed description
Few studies have examined BFR in patients sustaining operative foot and ankle injuries. Due to the weight bearing limitations and prolonged immobilization following these injuries, patients often experience increased time away from work and delays with return to sport. These factors are responsible for the rapid muscle atrophy that occurs in the immediate post injury period because of immobility and disuse. Recently, blood flow restriction (BFR) therapy has been shown to be effective in improving muscle strength and preventing atrophy when combined with low load resistance training physical therapy programs.7,8 Neuromuscular electrical stimulation (NMES) is an adjunctive agent that has been show to augment the effects of BFR alone.4 The null hypothesis is that a 2 week BFR + NMES + low load resistance training program in patients age \>= 18 recovering from foot and ankle surgery will have no effect on short term (2 weeks postop) lower extremity muscle hypertrophy or atrophy, patient pain and satisfaction, or functional recovery after foot and ankle surgery.
Interventions
PROCEDUREBFR+NMES at therapeutic level
This group will receive therapy with BFR+NMES devices used at settings that are deemed by prior studies to be therapeutic.
PROCEDUREBFR+NMES at sub therapeutic level
This means that the BFR tourniquet and the NMES device will be at such low settings as to not create the treatment effect but subject will have the equipments on their thigh during exercise
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* isolated, closed low-energy rotational ankle fracture without prior surgery or implants to injured area
Exclusion criteria
* history of Deep Vein Thrombosis in affected extremity * history of significant cardiac disease defined as a recent stent placement in past * history of peripheral arterial disease * history of sickle cell disease * history of coagulopathy * presenting to surgery \>14 days after injury
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess for calf muscle atrophy as measured by calf circumference | 2 weeks postop | Calf circumference will be measured using a measuring tape |
| Assess for calf muscle atrophy as measured by hand held dynamometry | 2 weeks postop | Hand held Dynamometry will be used to measure the length-tension relationship of the muscle in pounds |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient tolerance of the BFR treatment using the Visual Analogue Pain Scale. | 2 weeks postop | The Visual Analogue Pain Scale is used during the beginning, midpoint, and end of a session. This scale ranges from 0-10 which 0 being no pain and 10 being worst pain |
| Patient tolerance of the BFR treatment using the the Borg Rating of Perceived Exertion f | 2 weeks postop | The Borg Rating of Perceived Exertion will be used for each session and exercise. This rating ranges from 6-20 with 6 being no exertion at all, and 20 being maximum effort |
Outcome results
None listed