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Neuromuscular Electrical Stimulation
Electrical Stimulation for Ruptured Achilles Tendon
N/A
Recruiting
Research Sponsored by Penn State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Achilles tendon rupture
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1, 6, 12
Awards & highlights
Study Summary
This trial will test a new rehabilitation protocol using electrical stimulation to improve outcomes for patients who have ruptured their Achilles tendon.
Who is the study for?
This trial is for individuals who have experienced an Achilles tendon rupture and are undergoing recovery. It's not suitable for those who can't understand English, were treated non-operatively, had ruptures related to fluoroquinolone antibiotics use, or have conditions like diabetes or poor leg circulation that affect healing. People with augmented surgical repairs or allergies to ultrasound gel aren't eligible either.Check my eligibility
What is being tested?
The study is testing a new rehab method using Neuromuscular Electrical Stimulation (NMES) on patients with Achilles tendon ruptures. The aim is to see if NMES helps reduce muscle loss and improve the quality of the repaired tendon compared to standard care.See study design
What are the potential side effects?
While NMES is generally safe, potential side effects may include discomfort at the stimulation site, skin irritation from electrode placement, muscle fatigue after treatment sessions, and in rare cases mild pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a ruptured Achilles tendon.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 1, 6, 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1, 6, 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ability to perform a single heel rise
Secondary outcome measures
Achilles Total Rupture Score
Foot and Ankle Outcome Score (FAOS)
Gastrocnemius muscle cross-sectional area
+4 moreTrial Design
2Treatment groups
Active Control
Group I: ControlActive Control1 Intervention
Patients will follow standard therapy for Achilles tendon repair.
Group II: Neuromuscular Electrical StimulationActive Control1 Intervention
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.
Find a Location
Who is running the clinical trial?
Penn State UniversityLead Sponsor
355 Previous Clinical Trials
125,707 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot understand spoken English.I have had tendon ruptures from taking certain antibiotics.I am being treated without surgery.I have a ruptured Achilles tendon.I have a condition that affects my ability to walk or jump.My surgery involved adding extra tissue at the repair site.I am unable to give consent by myself.I do not have diabetes or heart conditions that affect my legs.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Neuromuscular Electrical Stimulation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the trial open to participants who are over 30 years of age?
"This trial is looking for patients aged 18 to 65; there are 19 separate studies recruiting prepubescent individuals and a further 49 trials that focus on seniors."
Answered by AI
Have any new volunteers been accepted into this research trial recently?
"Clinicaltrials.gov states that this particular trial, which was launched on July 15th 2022 and modified lastly on April 28th 2022 is no longer open for recruitment. Nonetheless, there are a total of 96 other active studies searching for participants at the moment."
Answered by AI
Is it possible to partake in this research study?
"This medical trial seeks a cohort of 50 individuals aged 18-65 that have experienced an Achilles tendon rupture. Besides meeting the age criteria, patients must satisfy all other prerequisites related to this condition."
Answered by AI
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