Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06009978

The Effect of Early Treatment With Neuromuscular Electrical Stimulation (NMES) After Achilles Tendon Rupture

Led by Vastra Gotaland Region · Updated on 2024-11-14

70

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

V

Vastra Gotaland Region

Lead Sponsor

G

Göteborg University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating new ways to treat patients who have suffered an Achilles tendon rupture (ATR), aiming to improve and personalize treatment beyond the current question of whether surgery should be used. This study focuses on the early use of Neuromuscular Electrical Stimulation (NMES) applied to calf muscles of the injured leg to see how it affects tendon length, functional performance, biomechanical factors, and patient-reported outcomes over both short and long terms. The research will also study how the healthy limb is affected by the injury to help prevent overuse injuries. The trial is a randomized controlled study involving 70 patients who will be divided into two groups. One group will receive NMES treatment at home, using a device applied to the calf muscles twice daily for 15 minutes during weeks 3 to 8 after injury, alongside standard rehabilitation. The other group will receive standard rehabilitation alone. Outcomes will be assessed at 3, 6, and 12 months, including measures like heel-rise height, tendon length via ultrasound, jumping ability, biomechanical data, and muscle recruitment patterns. Participants will undergo various tests including heel-rise work tests, ultrasound imaging of the tendon, and biomechanical evaluations during walking, running, and jumping. Muscle activity will also be measured with electromyography. These assessments will occur across multiple time points up to one year after injury. The study aims to gather detailed information to help guide rehabilitation and support patients in returning to their previous or higher physical activity levels.

CONDITIONS

Brief Title

Effect of Additional Treatment With NMES After Achilles Tendon Rupture

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with Achilles tendon rupture
  • Injury treated within two days of trauma
  • Rupture located in the mid portion of the tendon
  • Age between 18 and 65 years
  • Able to understand study instructions and provide consent
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Presence of pacemaker, intra cardiac defibrillator, or other active implants
  • Previous Achilles tendon rupture on either side
  • Earlier injury affecting lower leg function
  • Diabetes
  • Neurovascular disease
  • Immunosuppressive treatment
  • Difficulty understanding the language or study instructions
  • Unable to provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 5 weeks (weeks 3 to 8 after injury)

Participants use neuromuscular electrical stimulation (NMES) on the injured calf at home twice daily for 15 minutes from week 3 to week 8 after their Achilles tendon rupture, alongside standard rehabilitation.

1 baseline visit and multiple follow-up visits at 3, 6, and 12 months for assessment

Follow-up

Duration - Up to 12 months after injury

Participants attend follow-up visits to assess calf muscle function, tendon length, biomechanical variables, and patient-reported outcomes up to 12 months after injury.

Visits at 3, 6, and 12 months after injury

Trial Site Locations

Total: 1 location

1

Forskningsenhet Ortopedi, Sahlgrenska universitetssjukhuset, Mölndal

Mölndal, VGregion, Sweden, 43180

Actively Recruiting

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Research Team

K

Katarina Nilsson Helander, Ass.prof.

A

Annelie Brorsson, Ass.prof

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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