Muscle WeaknessNCT01825135
Electrical Stimulation to Strengthen Muscles in the Lower Legs in Patients Requiring Prolonged Mechanical Ventilation
A study testing Neuromuscular electrical stimulation in people with Muscle Weakness, run by RML Specialty Hospital at 1 site in United States.
Trial summary
The primary aim of this proposal is to test the effectiveness of NMES in improving functional status and muscle function in patients requirng prolonged mechanical ventilation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Weakness
- What is being tested?
- Neuromuscular electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- duration of mechanical ventilation for 14 days or more
- sufficiently awake
- able to speak and comprehend English
Who cannot join
- known primary neuromuscular disease
- lower extremities paresis or amputee
- patients with left-ventricular assist device (LVAD)
- cardiopulmonary instability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electrical Stimulation to Strengthen the Quadriceps Muscles in Patients Requiring Prolonged Mechanical Ventilation
The primary aim of this proposal is to test the effectiveness of NMES in improving functional status and muscle function in patients requirng prolonged mechanical ventilation
- Conditions
- Muscle Weakness
- Being tested
- Neuromuscular electrical stimulation, sham stimulation
- Keywords
- muscle strength, muscle function, functional status
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular electrical stimulationDevice
Also called 300PV™ neuromuscular stimulation (NMES)device
sham stimulationDevice
Also called 300PV™ Neuromuscular Stimulation (NMES) device
sham stimulation will be applied to the quadriceps
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular electrical stimulation | Experimental | Neuromuscular electrical stimulation (NMES) will be applied to the quadriceps muscles for 30 minutes Receives: Device: Neuromuscular electrical stimulation |
| Sham stimulation | Sham comparator | Sham stimulation will be applied to the quadriceps for 30 minutes Receives: Device: sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Functional Independence Measurement (FIM) score
Functional status as measured by modified Functional Independence Measurement (FIM) score
Measured: Hospital discharge, an expected average stay of 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startMar 2011
- Primary completionOct 2014
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- RML Specialty Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal Jubran, RML Specialty Hospital
- Investigators
- Amal Jubran, MD, Principal investigator, RML Specialty Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825135
- Sponsor's protocol ID
- AXJ012
- Status last verified
- May 2017
- First submitted
- 28 Mar 2013
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Stimulation to Strengthen the Quadriceps Muscles in Patients Requiring Prolonged Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT01825135
- Acronym / sponsor ID
- AXJ012
- Conditions
- Muscle Weakness
- Keywords
- muscle strength, muscle function, functional status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- RML Specialty HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 5 Apr 2013 (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.
The primary aim of this proposal is to test the effectiveness of NMES in improving functional status and muscle function in patients requirng prolonged mechanical ventilation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular electrical stimulation | Experimental | Device: Neuromuscular electrical stimulationNeuromuscular electrical stimulation (NMES) will be applied to the quadriceps muscles for 30 minutes |
| Sham stimulation | Sham comparator | Device: sham stimulationSham stimulation will be applied to the quadriceps for 30 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- duration of mechanical ventilation for 14 days or more
- sufficiently awake
- able to speak and comprehend English
Key exclusion criteria (4 listed)
- known primary neuromuscular disease
- lower extremities paresis or amputee
- patients with left-ventricular assist device (LVAD)
- cardiopulmonary instability
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 stimulationAlso: 300PV™ neuromuscular stimulation (NMES)device | Device | Neuromuscular electrical stimulation |
| sham stimulationAlso: 300PV™ Neuromuscular Stimulation (NMES) devicesham stimulation will be applied to the quadriceps | Device | Sham stimulation |
Primary outcome
modified Functional Independence Measurement (FIM) score
Time frame: Hospital discharge, an expected average stay of 5 weeks
Functional status as measured by modified Functional Independence Measurement (FIM) score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
Related trials for Muscle Weakness
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Recruiting
Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients
Mobility Limitation, Frailty
Not yet recruiting
Virtual Reality Training Dose for Arm Recovery After Stroke: Clinical and Blood Biomarker Responses
Stroke, Upper Extremity Paresis
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.
Amal Jubran, MD principal investigator
RML Specialty Hospital
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 in people with Muscle Weakness, run by RML Specialty Hospital at 1 site in United States.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 3 May 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 United States. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
modified Functional Independence Measurement (FIM) score (time frame: Hospital discharge, an expected average stay of 5 weeks). 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 3 May 2017.