Neuromuscular Electrical Stimulation During Immobilization Due to Ankle Fractures

Not Applicable

Terminated

• Conditions: Immobilization; Muscle Disuse Atrophy
• Interventions: Device: Neuromuscular Electrical Stimulation (NMES)

• Registration Number: NCT02469506
• Lead Sponsor: Maastricht University Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-06-04
• Study First Submitted QC: 2015-06-08
• Study First Posted: 2015-06-11
• Primary Completion: 2016-08-29
• Study Completion: 2016-08-30
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-04
• Last Update Posted: 2017-09-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NMES group	Neuromuscular Electrical Stimulation (NMES)	Patients will receive twice daily sessions of neuromuscular electrical stimulation (NMES).

Primary Outcome Measures

Name	Time	Method
Percentage change in calf muscle cross sectional area	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.	Measured by a single slice CT-scan of the calf muscle.

Secondary Outcome Measures

Name	Time	Method
Percentage change in type I and II muscle fiber cross sectional area	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.	Measured by immunohistochemical analyses of the muscle biopsies.
Percentage change in type I and II muscle fiber satellite cell content	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.	Measured by immunohistochemical analyses of the muscle biopsies.
Percentage change in type I and II muscle fiber intramuscular triglyceride content	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.	Measured by immunohistochemical analyses of the muscle biopsies.

Trial Locations

Locations (1)

Maastricht University Medical Centre; 🇳🇱 Maastricht, Limburg, Netherlands