Knee Arthroplasty Rehabilitation Outcomes Study

Rehabilitation Clinical Trial

— KAROS  

Official title:

Knee Arthroplasty Rehabilitation Outcomes Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02426190
• Other study ID #: 2012-347
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: December 31, 2017

Study information

• Verified date: April 2019
• Source: MedStar National Rehabilitation Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 386
• Est. completion date: December 31, 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rehabilitation
• Total Knee Arthroplasty

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	MedStar National Rehabilitation Network	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
MedStar National Rehabilitation Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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.	Discharge from outpatient rehabilitation (on average 2 months from baseline)