Effects of Contralateral Strength Training on Postoperative Strength Deficits in the Immobilized Lower Extremity

NCT ID: NCT03650374

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2025-12-01

Brief Summary

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.

Detailed Description

Group I will receive knee flexion and extension strength training exercises for the contralateral (non-operative) lower extremity in addition to standard of care postoperative rehabilitation. The 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.

Conditions

Meniscus; Detachment, Current Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

standard of care postoperative rehabilitation.

Group Type: ACTIVE_COMPARATOR

Standard of Care Rehabilitation

Intervention Type: OTHER

Knee flexion and extension strength training exercises for the contralateral (non-operative) lower extremity in addition to standard of care postoperative rehabilitation.

Group 2

experimental strength training

Group Type: EXPERIMENTAL

Experimental Strength Training

Intervention Type: OTHER

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.

Interventions

Standard of Care Rehabilitation

Knee flexion and extension strength training exercises for the contralateral (non-operative) lower extremity in addition to standard of care postoperative rehabilitation.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillem Gonzalez-Lomas, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Zachary Li

Role: CONTACT

zachary.li@nyulangone.org

317-517-0426

Facility Contacts

Sam Baron

Role: primary

sam.baron@nyumc.org

646-501-7223

Other Identifiers

18-01100

Identifier Type: -

Identifier Source: org_study_id