NMES for Achilles Tendon Rupture

NCT04727047 | Terminated FDA Device

• 1 other identifier: STUDY00016121
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Achilles Tendon Rupture

Outcome Measures

Primary Outcomes (1)

• Ability to perform a single heel rise

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

  Week 12

Secondary Outcomes (7)

• Tendon length

  Week 6 and12

• Tendon cross-sectional area

  Week 6, 12

• Gastrocnemius muscle cross-sectional area

  Week 1, 6, 12

• Soleus muscle cross-sectional area

  Week 1, 6, 12

• Foot and Ankle Outcome Score (FAOS)

  Week 6, 12

Study Arms (2)

Neuromuscular Electrical Stimulation

ACTIVE COMPARATOR

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.

Device: neuromuscular electrical stimulation

Control

NO INTERVENTION

Patients will follow standard therapy for Achilles tendon repair.

Interventions

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.

Neuromuscular Electrical Stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Achilles tendon rupture

You may not qualify if:

• 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

Sponsors & Collaborators

• Penn State University: lead

Study Sites (1)

Penn State University

State College, Pennsylvania, 16802, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: January 27, 2021
• Study Start: February 15, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

US (1)