Neuromuscular Electrical Stimulation During Immobilization Due to Ankle Fractures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-08-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Immobilization Muscle Disuse Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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NMES group

Patients will receive twice daily sessions of neuromuscular electrical stimulation (NMES).

Group Type EXPERIMENTAL

Neuromuscular Electrical Stimulation (NMES)

Intervention Type DEVICE

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.

Control group

Patients will receive daily visits by the investigator to check progress.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No