Post-operative Quadriceps WeaknessNCT02058862
Effect of a Home-based Electrical Stimulation on Quadriceps Function After Knee Surgery
An observational study of Post-operative Quadriceps Weakness and Post-operative Quadriceps Inhibition, run by University of Kentucky at 2 sites in United States.
Trial summary
The purpose of this study is to determine if a home-based electrical stimulation (ES) program is more effective than the standard of care (SOC) at improving quadriceps function, functional outcomes, patient reported outcomes, and treatment compliance in patients recovering from knee surgery. Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Post-operative Quadriceps Weakness, Post-operative Quadriceps Inhibition, Adherence to Post-operative Treatment
- How many people
- 87 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2014to Oct 2018
- Phase
- Observational
- 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 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients from the University of Kentucky Orthopaedics and Sports Medicine Clinic who are seeking surgical treatment for a disease/injury of the knee.
Who may be able to join
- Must be scheduled for surgery to address pain, injury, or dysfunction of the knee joint.
- Must be able to communicate using the English language
Who cannot join
- Previous surgery to the contralateral ankle, hip, or knee
- Injury to the hip, ankle, or contralateral knee in the past six months
- Currently being treated for low back pain
- Presence of a heart condition/pacemaker
- History and/or family history of seizures/epilepsy
- Vestibular or other balance disorders
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kentucky Musculoskeletal Laboratory
Lexington, Kentucky, 40506
University of Kentucky Orthopaedics and Sports Medicine Clinic
Lexington, Kentucky, 40517
About this study
Official title: Effects of a Superimposed Electrical Stimulation Knee Garment on Strength, Function, Inhibition, Cortical Excitability, and Patient Reported Outcomes After Knee Surgery
The purpose of this study is to determine if a home-based electrical stimulation (ES) program is more effective than the standard of care (SOC) at improving quadriceps function, functional outcomes, patient reported outcomes, and treatment compliance in patients recovering from knee surgery. It is hypothesized that there will be significantly better outcomes and compliance in ES group when compared to the SOC group.
Read the detailed description
The purpose of this study is to evaluate the effect of home-based neuromuscular electrical stimulation applied via a knee sleeve on strength, function, inhibition, and patient reported outcomes. Strength will be evaluated via isometric knee extension, neuromuscular inhibition will be assessed via a superimposed burst technique, and cortical excitability will be assessed via transcranial magnetic stimulation. In addition, we will evaluate function through a single-leg hop task, star excursion balance test, and a step down task. Patient reported outcomes will be assessed via the: Veterans Rand 12 Item Health Survey (VR-12), Knee Osteoarthritis Outcomes Score (KOOS), the International Cartilage Repair Society (ICRS), the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form, and the Lysholm scale.
Once a participant is identified as eligible and consents to enroll in the study, they will be allocated to either an intervention or control group. The participants in the intervention group will receive a knee sleeve that has a neuromuscular ES unit embedded into the garment (EMPI Phoenix, DJO Global, Vista, California) in addition to SOC. A superimposed electrical signal (maximal toleration) will be utilized during treatment in order to successfully overload the muscle. During the electrical stimulation the participants will be instructed to perform an isometric contraction and hold this contraction through the length of the stimulation. Beginning one week post-operatively the participants will be instructed to perform NMES treatment 3 times a day for 20 minutes 5 times a week for 12 weeks. The stimulation will be delivered at a frequency of 75Hz with a duty cycle of 4 seconds on and 10 seconds off. The control group will be treated with the current SOC, performing a home-based treatment of volitional isometrics contractions without the addition of neuromuscular electrical stimulation beginning on the third day post-operatively. Participants will perform 20 isometric contractions holding each contraction for 10 seconds 3 times a day 5 times a week for 12 weeks. Participants will be instructed to keep a treatment log documenting at each session how many exercises and at what intensity they performed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Isometric knee extension torque
Knee extension torque derived from a maximal voluntary isometric contraction
Measured: Preoperative baseline, 1 month post-operative, 3-4 month post-operative, 6 month post-operative, and 12 month post-operative
Quadriceps activation
Central activation ratio of the quadriceps derived from the superimposed burst technique
Measured: Preoperative, 3-4 month post-operative, 6 month post-operative, and 12 month post-operative
Secondary outcomes (3)
Patient-reported outcomes
Patient-reported outcome measures will include the following: Veterans Rand 12 Item Health Survey (VR-12), Knee Osteoarthritis Outcomes Score (KOOS), the International Cartilage Repair Society (ICRS), the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form, and the Lysholm scale
Measured: Preoperative, 1 month post-operative, 3-4 month post-operative, 6 month post-operative, and 12 month post-operative
Functional outcomes
Functional outcome measures will include the following: Single-leg hop, 30-second step down, and star-excursion balance test.
Measured: Preoperative, 3-4 month post-operative, 6 month post-operative, and 12 month post-operative
Cortical excitability
Individuals who have been diagnosed with epilepsy or have a family history of epilepsy may be at risk of seizure during cortical excitability testing. Therefore, these individuals will be excluded from this study. Otherwise, this measure is considered to be safe and is used in the realms of both medicine and research.
Measured: Preoperative, 1 month post-operative, 3-4 month post-operative, 6 month post-operative, and 12 month post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2017
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative Quadriceps 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Collaborators
- DonJoy Orthopedics
- Responsible party
- Principal investigator, Caitin Conley, University of Kentucky
- Investigators
- Conrad M Gabler, PhD, ATC, Principal investigator, University of KentuckyCaitlin E Whale Conley, PhD, ATC, Principal investigator, University of KentuckyCarl G Mattacola, PhD, ATC, Study chair, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058862
- Sponsor's protocol ID
- 13-0776-F2L
- Status last verified
- Oct 2018
- First submitted
- 6 Feb 2014
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Superimposed Electrical Stimulation Knee Garment on Strength, Function, Inhibition, Cortical Excitability, and Patient Reported Outcomes After Knee Surgery
- ClinicalTrials.gov ID
- NCT02058862
- Acronym / sponsor ID
- 13-0776-F2L
- Conditions
- Post-operative Quadriceps Weakness, Post-operative Quadriceps Inhibition, Adherence to Post-operative Treatment, Post-operative Lower Extremity Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Collaborators
- DonJoy Orthopedics
- Study start
- May 2014 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 10 Feb 2014 (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 purpose of this study is to determine if a home-based electrical stimulation (ES) program is more effective than the standard of care (SOC) at improving quadriceps function, functional outcomes, patient reported outcomes, and treatment compliance in patients recovering from knee surgery. It is hypothesized that there will be significantly better outcomes and compliance in ES group when compared to the SOC group.
Detailed description
The purpose of this study is to evaluate the effect of home-based neuromuscular electrical stimulation applied via a knee sleeve on strength, function, inhibition, and patient reported outcomes. Strength will be evaluated via isometric knee extension, neuromuscular inhibition will be assessed via a superimposed burst technique, and cortical excitability will be assessed via transcranial magnetic stimulation. In addition, we will evaluate function through a single-leg hop task, star excursion balance test, and a step down task. Patient reported outcomes will be assessed via the: Veterans Rand 12 Item Health Survey (VR-12), Knee Osteoarthritis Outcomes Score (KOOS), the International Cartilage Repair Society (ICRS), the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form, and the Lysholm scale.
Once a participant is identified as eligible and consents to enroll in the study, they will be allocated to either an intervention or control group. The participants in the intervention group will receive a knee sleeve that has a neuromuscular ES unit embedded into the garment (EMPI Phoenix, DJO Global, Vista, California) in addition to SOC. A superimposed electrical signal (maximal toleration) will be utilized during treatment in order to successfully overload the muscle. During the electrical stimulation the participants will be instructed to perform an isometric contraction and hold this contraction through the length of the stimulation. Beginning one week post-operatively the participants will be instructed to perform NMES treatment 3 times a day for 20 minutes 5 times a week for 12 weeks. The stimulation will be delivered at a frequency of 75Hz with a duty cycle of 4 seconds on and 10 seconds off. The control group will be treated with the current SOC, performing a home-based treatment of volitional isometrics contractions without the addition of neuromuscular electrical stimulation beginning on the third day post-operatively. Participants will perform 20 isometric contractions holding each contraction for 10 seconds 3 times a day 5 times a week for 12 weeks. Participants will be instructed to keep a treatment log documenting at each session how many exercises and at what intensity they performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients from the University of Kentucky Orthopaedics and Sports Medicine Clinic who are seeking surgical treatment for a disease/injury of the knee.
Key inclusion criteria (2 listed)
- Must be scheduled for surgery to address pain, injury, or dysfunction of the knee joint.
- Must be able to communicate using the English language
Key exclusion criteria (6 listed)
- Previous surgery to the contralateral ankle, hip, or knee
- Injury to the hip, ankle, or contralateral knee in the past six months
- Currently being treated for low back pain
- Presence of a heart condition/pacemaker
- History and/or family history of seizures/epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Isometric knee extension torque
Time frame: Preoperative baseline, 1 month post-operative, 3-4 month post-operative, 6 month post-operative, and 12 month post-operative
Knee extension torque derived from a maximal voluntary isometric contraction
Quadriceps activation
Time frame: Preoperative, 3-4 month post-operative, 6 month post-operative, and 12 month post-operative
Central activation ratio of the quadriceps derived from the superimposed burst technique
3 secondary outcomes
Patient-reported outcomes
Time frame: Preoperative, 1 month post-operative, 3-4 month post-operative, 6 month post-operative, and 12 month post-operative
Functional outcomes
Time frame: Preoperative, 3-4 month post-operative, 6 month post-operative, and 12 month post-operative
Cortical excitability
Time frame: Preoperative, 1 month post-operative, 3-4 month post-operative, 6 month post-operative, and 12 month post-operative
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 9 Oct 2018.
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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.
Conrad M Gabler, PhD, ATC principal investigator
University of Kentucky
Caitlin E Whale Conley, PhD, ATC principal investigator
University of Kentucky
Carl G Mattacola, PhD, ATC study chair
University of Kentucky
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-operative Quadriceps Weakness and Post-operative Quadriceps Inhibition, run by University of Kentucky at 2 sites 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 2 inclusion and 6 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 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Isometric knee extension torque (time frame: Preoperative baseline, 1 month post-operative, 3-4 month post-operative, 6 month post-operative, and 12 month post-operative). The study lists 2 primary outcomes in all. 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 9 Oct 2018.