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Terminated

NCT Number: NCT04727047

NMES for Achilles Tendon Rupture

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.

Why the study stopped: Recruitment of the number of required patients not completed
Terminated

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State University

State College, Pennsylvania, 16802, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Achilles tendon rupture

Exclusion criteria

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

Treatment and study plan

Neuromuscular Electrical Stimulation

Device

All subjects will receive standard rehabilitation for Achilles tendon repair. In addition, neuromuscular electrical stimulation will be applied to the calf muscles of the injured leg. The stimulation volume, the electrode placement and the intensity of the stimulation will be selected based on the mechanical strength of healing Achilles tendon. The intervention will be applied for 6 weeks after repair.

Primary outcomes

  1. Ability to Perform a Single Heel Rise

    Time frame: Week 12

    The ability of patients to perform a single heel rise using the injured will be tested.

Secondary outcomes

  1. Tendon Length

    Time frame: Week12

    Length from the tendon insertion to the myotendinous junction

  2. Tendon Thickness

    Time frame: Week 6, 12

    Tendon thickness measured via ultrasound imaging at the rupture location

  3. Gastrocnemius Muscle Cross-sectional Area

    Time frame: Week 6, 12

    Area of the tendon measured via ultrasound imaging at the rupture location

  4. Soleus Muscle Estimated Volume

    Time frame: Week 6, 12

    Muscle volume estimated from ultrasound imaging

  5. Foot and Ankle Outcome Score (FAOS)

    Time frame: Week 6, 12

    Score that assesses patient pain, other symptoms, function in daily living, function in sport and recreation, and foot/ankle related quality of life. Scores range from 0 to 100 with a score of 0 indicating the worst possible foot/ankle symptoms and 100 indicating no foot/ankle symptoms.

  6. Achilles Total Rupture Score

    Time frame: Week 6, 12

    It consists of ten items evaluating aspects of symptoms and function. Each item has scores ranging between 0 and 10 on a Likert scale. The instrument therefore has a maximum score of 100, which corresponds to no symptoms and full function.

  7. Tampa Scale for Kinesiophobia (TSK)

    Time frame: Week 6, 12

    Questionnaire based on evaluation of fear of movement, fear of physical activity, and fear avoidance. The total score of the scale range from 17- 68, where 17 means no kinesiophobia, 68 means severe kinesiophobia, and score ± 37 indicates there is kinesiophobia.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Penn State University

Other

Registry information

Official study title

Neuromuscular Electrical Stimulation for Achilles Tendon Rupture Rehabilitation

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 27, 2021
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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