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

Sponsor
Maastricht University Medical Center (Other)
Overall Status
Terminated
CT.gov ID
NCT02469506
Collaborator
(none)
1
Enrollment
1
Location
2
Arms
18.9
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Neuromuscular Electrical Stimulation (NMES)
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Effects of Daily Neuromuscular Electrical Stimulation on Muscle Mass During Long-term Unilateral Ankle Immobilization in Adults With Ankle Fractures
Study Start Date :
Feb 1, 2015
Actual Primary Completion Date :
Aug 29, 2016
Actual Study Completion Date :
Aug 30, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: NMES group

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

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.
No Intervention: Control group

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Maastricht University Medical Centre Maastricht Limburg Netherlands 6229ER

Sponsors and Collaborators

  • Maastricht University Medical Center

Investigators

  • Principal Investigator: Luc van Loon, Prof, Maastricht University Medical Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lex Verdijk, Prof. Dr. Luc. J.C. van Loon, Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT02469506
Other Study ID Numbers:
  • METC 14-3-050
First Posted:
Jun 11, 2015
Last Update Posted:
Sep 6, 2017
Last Verified:
Sep 1, 2017
Additional relevant MeSH terms:
Muscular Disorders, Atrophic
Ankle Fractures

Study Results

No Results Posted as of Sep 6, 2017