Clinical trial NCT04727047: NMES for Achilles Tendon Rupture
Official title: Neuromuscular Electrical Stimulation for Achilles Tendon Rupture Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Achilles Tendon Rupture
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The majority of patients suffering an Achilles tendon rupture develop long term functional deficits in the affected leg. The goal of the proposed study is to evaluate a new rehabilitation protocol using Neuromuscular Electrical Stimulation (NMES) for reducing muscle atrophy and improving tendon properties. If proven beneficial, the proposed protocol can be easily adopted and incorporated as part of routine care for Achilles tendon rupture.

Detailed description: Achilles Tendon Ruptures (ATR) are common and permanently affect the function of the lower leg. Regardless of treatment approach the majority of patients develop long term functional deficits, which include decreased plantar flexion strength, lower heel-rise height, and altered gait patterns. It is believed that tendon lengthening and calf muscle atrophy, which develop during the first few weeks of recovery, are major factors contributing to these functional deficits. The initial development of atrophy is likely caused by reduced loading and muscle activity of the affected leg. However, long-term atrophy may be related to tendon elongation. On the other hand, tendon elongation initially rises during the first few weeks of unloading and slowly reduces, but not completely, when loading is resumed. However, atrophied calf muscles may not provide sufficient loading for optimal tendon recovery. Therefore, there seems to be vicious spiral between tendon elongation and muscle atrophy.

The objective of this study is to develop a neuromuscular electrical stimulation (NMES) rehabilitation protocol for Achilles tendon ruptures. Our preliminary data has shown that force applied to the tendon can be modulated using electrical intensity and pad placement. Therefore, NMES can produce significant contraction in the calf muscles and induce controllable, low-magnitude, cyclic loading to the tendon; which cannot be achieved with voluntary muscle contractions. This approach can potentially overcome limitations of the current rehabilitation protocols.

Eligibility criteria: Inclusion Criteria:

* Achilles tendon rupture

Exclusion Criteria:

1. Those unable to understand spoken English.
2. Participants treated non-operatively
3. Augmented surgical repair (i.e., use of additional tissue at the repair site)
4. Tendon ruptures associated with the use of fluoroquinolones (Examples include ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), and ofloxacin (Floxin))
5. Allergy to ultrasound gel
6. Any other condition affecting the ability of the participant to walk or jump
7. Any other health conditions known to impair normal healing: Diabetes, Cardiovascular conditions decreasing blood supply to the leg
8. Those unable to consent

Primary outcomes:
measure: Ability to perform a single heel rise
timeFrame: Week 12
Secondary outcomes:
measure: Tendon length
timeFrame: Week 6 and12
measure: Tendon cross-sectional area
timeFrame: Week 6, 12
measure: Gastrocnemius muscle cross-sectional area
timeFrame: Week 1, 6, 12
measure: Soleus muscle cross-sectional area
timeFrame: Week 1, 6, 12
measure: Foot and Ankle Outcome Score (FAOS)
timeFrame: Week 6, 12
measure: Achilles Total Rupture Score
timeFrame: Week 6, 12
measure: Tampa Scale for Kinesiophobia (TSK)
timeFrame: Week 6, 12
Other outcomes:
Locations:
city: State College
country: United States
facility: Penn State University
state: Pennsylvania
Study officials:
References: