- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03650374
Effects of Contralateral Strength Training on Postoperative Strength Deficits in the Immobilized Lower Extremity
This is a prospective, randomized controlled trial that will enroll patients undergoing unilateral meniscal root repair or meniscus transplant. The objective of this study is to determine if immediate postoperative strength training of the contralateral (non-surgical) lower extremity reduces postoperative loss of strength in an immobilized lower extremity.
After the completion of surgery, patients will be randomized to either the experimental treatment (Group 1) or control group (Group II)for postoperative rehabilitation.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- New York University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient is indicated for meniscal root repair
- Patient is indicated for meniscus transplant
- Patient is at least 18 years of age
- Patient is expected to survive at least 1 year beyond surgery
- Patient has intact lower extremities bilaterally
- Patient is willing to participate by complying with pre-and post-operative visit requirements
- Patient is willing and able to review and sign a study informed consent form
Exclusion Criteria:
- Lower extremity musculoskeletal defects
- Systemic neuromuscular disorders
- Failure to complete pre-operative BIDOEX strength assessment
- Failure to complete pre-operative self-assessment score intake forms
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group 1
standard of care postoperative rehabilitation.
|
Knee flexion and extension strength training exercises for the contralateral (non-operative) lower extremity in addition to standard of care postoperative rehabilitation.
|
|
Experimental: Group 2
experimental strength training
|
Will be performed with moderate resistance and will require moderate effort.
Exercises will include unilateral leg presses, lunges, step ups, and step downs.
These exercises are performed as standard of care but are not typically introduced into the physical therapy regimen until 10-12 weeks postoperatively.
In the experimental group, these exercises will be introduced starting with the first postoperative physical therapy session, but only for the contralateral (non-operative) leg.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
KOOS
Time Frame: 6 Weeks, 3 Months, 6 Months
|
A patient-reported outcome measurement instrument, developed to assess the patient's opinion about their knee and associated problems.
|
6 Weeks, 3 Months, 6 Months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Guillem Gonzalez-Lomas, MD, NYU Langone Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 18-01100
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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