NMES for Achilles Tendon Rupture

NCT ID: NCT04727047

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-15
• Study Completion Date: 2024-12-31

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.

Conditions

Achilles Tendon Rupture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neuromuscular Electrical Stimulation

Neuromuscular electrical stimulation will be applied to the calf muscles. The level of stimulation will be increased weekly from 10 to 30 mA during the first 6 weeks after surgery.

In addition, patients will follow standard therapy for Achilles tendon repair.

Group Type: ACTIVE_COMPARATOR

neuromuscular electrical stimulation

Intervention Type: 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.

Control

Patients will follow standard therapy for Achilles tendon repair.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

neuromuscular electrical stimulation

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Penn State University

OTHER

Sponsor Role: lead

Responsible Party

Daniel Cortes

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Penn State University

State College, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY00016121

Identifier Type: -

Identifier Source: org_study_id