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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
386
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.
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.
MedStar National Rehabilitation Network
Washington D.C., District of Columbia, United States
AM-PAC (Activity Measure for Post Acute Care) Basic Mobility score: Baseline
The primary outcome measure is the AM-PAC Basic Mobility score. AM-PAC is a patient-reported instrument to measure functional level in 3 domains: basic mobility, daily activity, and applied cognition. For the purpose of the study, only the basic mobility domain was measured. Using item-response theory, the AM-PAC program selects the most representative questions from its extensive item bank to ask when measuring a patient's functional level. This study used the AM-PAC basic mobility paper short form designed for outpatient settings. The short-form consists of 18 questions and produces a raw score (18 to 72) transformed into a score ranging from 29.41 to 80.30 based on item-degree of difficulty. Higher transformed scores denote higher functional mobility: 34 - 51.9 = limited indoor mobility; 52 - 65.9 = enhanced indoor mobility; 66 and above = outdoor mobility.
Time frame: Baseline
AM-PAC (Activity Measure for Post Acute Care) Basic Mobility score: Discharge from outpatient rehabilitation
The primary outcome measure is the AM-PAC Basic Mobility score upon discharge from outpatient therapy. AM-PAC is a patient-reported instrument to measure functional level in 3 domains: basic mobility, daily activity, and applied cognition. For the purpose of the study, only the basic mobility domain was measured. Using item-response theory, the AM-PAC program selects the most representative questions from its extensive item bank to ask when measuring a patient's functional level. This study used the AM-PAC basic mobility paper short form designed for outpatient settings. The short-form consists of 18 questions and produces a raw score (18 to 72) transformed into a score ranging from 29.41 to 80.30 based on item-degree of difficulty. Higher transformed scores denote higher functional mobility: 34 - 51.9 = limited indoor mobility; 52 - 65.9 = enhanced indoor mobility; 66 and above = outdoor mobility.
Time frame: Discharge from outpatient rehabilitation (on average 2 months from baseline)
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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.
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.