Neuromuscular Electrical Stimulation During Immobilization Due to Ankle Fractures — ANKL-ES  

Immobilization Clinical Trial

Official title: The Effects of Daily Neuromuscular Electrical Stimulation on Muscle Mass During Long-term Unilateral Ankle Immobilization in Adults With Ankle Fractures

Status Terminated

Clinical Trial Summary

Rationale: Situations such as fractures of the lower extremity can necessitate a prolonged period of immobilization in otherwise healthy individuals. Long-term immobilization of the lower extremity has shown to cause significant reductions in skeletal muscle mass, already occurring during the early stages of disuse. Accordingly, feasible strategies for attenuating this loss of muscle during disuse need to be pursued. Local neuromuscular electrical stimulation (NMES) offers such a potential strategy but, as yet, remains untested during prolonged muscle disuse in a clinical setting.

Objective: To investigate whether twice daily local (gastrocnemius/soleus) NMES attenuates muscle loss during 2 weeks of unilateral ankle immobilization.

Study design: Randomized, parallel (two groups) study design.

Study population: 30 adults (18-65 y) with any form of closed ankle fractures needing surgical treatment.

Intervention: Twice daily neuromuscular electrical stimulation (NMES) or no intervention.

Main study parameters/endpoints: Primary: Calf muscle (gastrocnemius) cross sectional area (CSA) as determined by CT scan. Secondary: type I and II muscle fiber CSA and SC content, intramuscular triglyceride content and mRNA and protein expression of anabolic signaling proteins.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Ankle Fractures
• Atrophy
• Immobilization
• Muscle Disuse Atrophy
• Muscular Disorders, Atrophic

• NCT number: NCT02469506
• Study type: Interventional
• Source: Maastricht University Medical Center
• Status: Terminated
• Phase: N/A
• Start date: February 2015
• Completion date: August 30, 2016