NCT02426190

Knee Arthroplasty Rehabilitation Outcomes Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 386 (actual)
• Sponsor: MedStar National Rehabilitation Network · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The objective of the KAROS study is to compare rehabilitation outcomes between 3 proposed protocols and a current standard of care protocol for the purpose of identifying better practice for outpatient rehabilitation among patients with single total knee replacement. The 3 advanced protocols involve use of an anti-gravity treadmill and/or the patterned electrical neuromuscular stimulation (PENS). Both medical modalities have been cleared by the FDA to be used in medical rehabilitation, including total knee replacement.

Conditions

• Total Knee Arthroplasty
• Rehabilitation

Interventions

Type	Name	Description
OTHER	Anti-gravity treadmill	The intervention is to ask study participants to ambulate using an anti-gravity treadmill that integrates patented, NASA Differential Air Pressure (DAP) technology -- a precise air calibration system -- to uniformly reduce gravitational load and body weight during the warm-up phase of an outpatient physical therapy following a single total knee replacement.
OTHER	PENS - neuro-muscular stimulation	The intervention is to ask study participants to warm up using Patterned Electrical Neuromuscular Stimulation (PENS) - that closely replicates the body's normal muscle and nerve firing patterns -- on his/her surgical leg in conjunction with a recumbent bike or a Nu-step bike during the warm-up phase of an outpatient physical therapy following a single total knee replacement.
OTHER	Anti-gravity treadmill & PENS - neuro-muscular stimulation	The intervention is to ask study participants to ambulate using an anti-gravity treadmill in conjunction with use of Patterned Electrical Neuromuscular Stimulation (PENS) during the warm-up phase of an outpatient physical therapy following a single total knee replacement.
OTHER	Recumbent or Nu-step bike	This is the active comparator of the trial that participants are asked to use either a recumbent or Nu-step bike normally seen in an outpatient physical therapy clinic to warm-up during a physical therapy session following a single total knee replacement.

Timeline

• Start date: 2014-10-01
• Primary completion: 2017-12-01
• Completion: 2017-12-31
• First posted: 2015-04-24
• Last updated: 2019-04-16

Locations

1 site across 1 country: United States