Neuromuscular Electrical Stimulation During Immobilization Due to Ankle Fractures

Immobilization Clinical Trial

— ANKL-ES  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02469506
• Other study ID #: METC 14-3-050
• Status: Terminated
• Phase: N/A
• First received: June 4, 2015
• Last updated: September 4, 2017
• Start date: February 2015
• Est. completion date: August 30, 2016

Study information

• Verified date: September 2017
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 30, 2016
• Est. primary completion date: August 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Unilateral closed ankle fracture (Weber type A, B or C)

• Aged from 18-65 years

• 18.5 < BMI < 30 kg/m2

• Undergoing surgical treatment

Exclusion Criteria:

• Additional fractures beside ankle fracture (e.g. multi-trauma following a car accident)

• Use of oral anticoagulants such as vitamin K-antagonists (e.g. acenocoumarol and fenprocoumon) and direct-acting or new oral anticoagulants (e.g. apixaban, dabigatran and rivaroxaban).

• Any family history of thrombosis

• All co-morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthritis, spasticity/rigidity, all neurological disorders and paralysis).

• Myocardial infarction within the last 3 years

Related Conditions & MeSH terms

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

Intervention

Device:
• Neuromuscular Electrical Stimulation (NMES)
The protocol will consist of a warm-up period (5 min), a stimulation period (30min), and a cooling-down period (5min). Stimulation will be provided by an Enraf Nonius TensMed S84 stimulation device.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change in calf muscle cross sectional area	Measured by a single slice CT-scan of the calf muscle.	Baseline measurements will be performed at the day of the surgical intervention for the ankle fracture. Post measurements will be performed at the last day of the subsequent 2-week period of immobilization with a lower leg cast.
Secondary	Percentage change in type I and II muscle fiber cross sectional area	Measured by immunohistochemical analyses of the muscle biopsies.	Baseline measurements will be performed at the day of the surgical intervention for the ankle fracture. Post measurements will be performed at the last day of the subsequent 2-week period of immobilization with a lower leg cast.
Secondary	Percentage change in type I and II muscle fiber satellite cell content	Measured by immunohistochemical analyses of the muscle biopsies.	Baseline measurements will be performed at the day of the surgical intervention for the ankle fracture. Post measurements will be performed at the last day of the subsequent 2-week period of immobilization with a lower leg cast.
Secondary	Percentage change in type I and II muscle fiber intramuscular triglyceride content	Measured by immunohistochemical analyses of the muscle biopsies.	Baseline measurements will be performed at the day of the surgical intervention for the ankle fracture. Post measurements will be performed at the last day of the subsequent 2-week period of immobilization with a lower leg cast.