ImmobilizationANKL-ESNCT02469506
Neuromuscular Electrical Stimulation During Immobilization Due to Ankle Fractures
A study testing Neuromuscular Electrical Stimulation (NMES) in people with Immobilization and Muscle Disuse Atrophy, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Immobilization, Muscle Disuse Atrophy
- What is being tested?
- Neuromuscular Electrical Stimulation (NMES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2015to 30 Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral closed ankle fracture (Weber type A, B or C)
- Aged from 18-65 years
- 18.5 < BMI < 30 kg/m2
- Undergoing surgical treatment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre
Maastricht, Limburg, 6229ER
About this study
Official title: The Effects of Daily Neuromuscular Electrical Stimulation on Muscle Mass During Long-term Unilateral Ankle Immobilization in Adults With Ankle Fractures
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.
Read more
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.
- Conditions
- Immobilization, Muscle Disuse Atrophy
- Being tested
- Neuromuscular Electrical Stimulation (NMES)
- Medical subject headings
- Muscular Disorders, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Electrical Stimulation (NMES)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.
| Study group | Role | What they receive |
|---|---|---|
| NMES group | Experimental | Patients will receive twice daily sessions of neuromuscular electrical stimulation (NMES). Receives: Device: Neuromuscular Electrical Stimulation (NMES) |
| Control group | No intervention | Patients will receive daily visits by the investigator to check progress. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in calf muscle cross sectional area
Measured by a single slice CT-scan of the calf muscle.
Measured: 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 outcomes (3)
Percentage change in type I and II muscle fiber cross sectional area
Measured by immunohistochemical analyses of the muscle biopsies.
Measured: 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.
Percentage change in type I and II muscle fiber satellite cell content
Measured by immunohistochemical analyses of the muscle biopsies.
Measured: 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.
Percentage change in type I and II muscle fiber intramuscular triglyceride content
Measured by immunohistochemical analyses of the muscle biopsies.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startFeb 2015
- Primary completion29 Aug 2016
- Study completion30 Aug 2016
Why it stopped: Minimal to no inclusion.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmobilizationStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lex Verdijk, Maastricht University Medical Center
- Investigators
- Luc van Loon, Prof, Principal investigator, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02469506
- Sponsor's protocol ID
- METC 14-3-050
- Acronym
- ANKL-ES
- Status last verified
- Sep 2017
- First submitted
- 4 Jun 2015
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Daily Neuromuscular Electrical Stimulation on Muscle Mass During Long-term Unilateral Ankle Immobilization in Adults With Ankle Fractures
- ClinicalTrials.gov ID
- NCT02469506
- Acronym / sponsor ID
- ANKL-ES / METC 14-3-050
- Conditions
- Immobilization, Muscle Disuse Atrophy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Minimal to no inclusion.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- 29 Aug 2016 (actual)
- Study completion
- 30 Aug 2016 (actual)
- First posted
- 11 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NMES group | Experimental | Device: Neuromuscular Electrical Stimulation (NMES)Patients will receive twice daily sessions of neuromuscular electrical stimulation (NMES). |
| Control group | No intervention | –Patients will receive daily visits by the investigator to check progress. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Unilateral closed ankle fracture (Weber type A, B or C)
- Aged from 18-65 years
- 18.5 < BMI < 30 kg/m2
- Undergoing surgical treatment
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | NMES group |
Primary outcome
Percentage change in calf muscle cross sectional area
Time frame: 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.
3 secondary outcomes
Percentage change in type I and II muscle fiber cross sectional area
Time frame: 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.
Percentage change in type I and II muscle fiber satellite cell content
Time frame: 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.
Percentage change in type I and II muscle fiber intramuscular triglyceride content
Time frame: 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.
Results and safety
The study was stopped early (reason given: Minimal to no inclusion.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc van Loon, Prof principal investigator
Maastricht University Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular Electrical Stimulation (NMES) in people with Immobilization and Muscle Disuse Atrophy, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Minimal to no inclusion.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in calf muscle cross sectional area (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2017.