Rehabilitation, Total Knee Arthroplasty
Conditions
Brief 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.
Interventions
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.
OTHERPENS - 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.
OTHERAnti-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.
OTHERRecumbent 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.
Sponsors
MedStar National Rehabilitation Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who undergo an elective single total knee arthroplasty and initiate their outpatient rehabilitation therapy within 3 weeks after surgery. * Patients who are 40 years old or older. * Patients who weight less than 320 lb to accommodate the weight limit to use the anti-gravity treadmill.
Exclusion criteria
* Patients who had any lower extremity joint replacement less than 1 year prior the current total knee replacement. * Patients who are pregnant or may be pregnant. * Patients who have a medical history of neurologic disorders. * Patients who have received more than 2 weeks of other formats of rehabilitation prior their outpatient rehabilitation program. * Patients who received any cancer treatment in the past year prior the current surgery. * Patients who have uncontrolled cardiovascular hypertension. * Patients who have cardiac demand pacemakers and/or implanted defibrillators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AM-PAC (Activity Measure for Post Acute Care) Basic Mobility score: Baseline | 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. |
| AM-PAC (Activity Measure for Post Acute Care) Basic Mobility score: Discharge from outpatient rehabilitation | Discharge from outpatient rehabilitation (on average 2 months from baseline) | 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. |
Countries
United States
Outcome results
None listed