Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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