Effect of a Home-based Electrical Stimulation on Quadriceps Function After Knee Surgery

NCT02058862 | Completed

• 1 other identifier: 13-0776-F2L
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 2

Brief 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. It is hypothesized that there will be significantly better outcomes and compliance in ES group when compared to the SOC group.

Conditions

Post-operative Quadriceps Weakness; Post-operative Quadriceps Inhibition; Adherence to Post-operative Treatment; Post-operative Lower Extremity Function

Outcome Measures

Primary Outcomes (2)

• Isometric knee extension torque

  Knee extension torque derived from a maximal voluntary isometric contraction

  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

  Preoperative, 3-4 month post-operative, 6 month post-operative, and 12 month post-operative

Secondary Outcomes (3)

• Patient-reported outcomes

  Preoperative, 1 month post-operative, 3-4 month post-operative, 6 month post-operative, and 12 month post-operative

• Functional outcomes

  Preoperative, 3-4 month post-operative, 6 month post-operative, and 12 month post-operative

• Cortical excitability

  Preoperative, 1 month post-operative, 3-4 month post-operative, 6 month post-operative, and 12 month post-operative

Other Outcomes (1)

• Treatment compliance

  Preoperative, 1 month post-operative, 3-4 month post-operative, 6 month post-operative, and 12 month post-operative

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Must be scheduled for surgery to address pain, injury, or dysfunction of the knee joint.
• Must be able to communicate using the English language

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kentucky: lead
• DonJoy Orthopedics: collaborator

Study Sites (2)

University of Kentucky Musculoskeletal Laboratory

Lexington, Kentucky, 40506, United States

Location

University of Kentucky Orthopaedics and Sports Medicine Clinic

Lexington, Kentucky, 40517, United States

Location

Study Officials

• Conrad M Gabler, PhD, ATC

  University of Kentucky

  PRINCIPAL INVESTIGATOR

• Caitlin E Whale Conley, PhD, ATC

  University of Kentucky

  PRINCIPAL INVESTIGATOR

• Carl G Mattacola, PhD, ATC

  University of Kentucky

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, ATC

Study Record Dates

• First Submitted: February 6, 2014
• First Posted: February 10, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: October 1, 2018
• Last Updated: October 9, 2018

Record last verified: 2018-10

Locations

US (2)