NCT02945553

Prevention of Skeletal Muscle Adaptations to Traumatic Knee Injury and Surgery

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: University of Vermont · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Traumatic knee injury is common and highly debilitating. Surgical reconstruction/repair improves knee biomechanics and function, but neuromuscular dysfunction persist for years despite rehabilitation, hindering resumption of normal activities, increasing risk of further injury and, in a majority of patients, hastening the development of knee osteoarthritis (OA). Our goal in this research study is to evaluate the utility of neuromuscular electrical stimulation (NMES), initiated following injury and maintained through the early post-surgical period, to prevent muscle atrophy and intrinsic contractile dysfunction compared to active control intervention of micro-electrical stimulation.

Conditions

• Anterior Cruciate Ligament Reconstruction

Interventions

Type	Name	Description
DEVICE	Neuromuscular electrical stimulation	Neuromuscular electrical stimulation (NMES) will be performed 5 times/week for one hour each day. NMES will start within 1 week of injury and continue till 3 weeks following surgery.
DEVICE	Microstimulation	Microstimulation will be performed 5 times/week for one hour each day. Microstimulation will start within 1 week of injury and continue till 3 weeks following surgery.

Timeline

• Start date: 2016-10-01
• Primary completion: 2019-09-01
• Completion: 2019-09-01
• First posted: 2016-10-26
• Last updated: 2021-01-05
• Results posted: 2021-01-05

Locations

1 site across 1 country: United States