Knee Arthroplasty Rehabilitation Outcomes Study (KAROS)

MedStar National Rehabilitation Network

Status: Completed

Conditions: Rehabilitation; Total Knee Arthroplasty

Treatments: Other: Anti-gravity treadmill & PENS - neuro-muscular stimulation; Other: PENS - neuro-muscular stimulation; Other: Anti-gravity treadmill; Other: Recumbent or Nu-step bike

Study type: Interventional

Funder types: Other

Identifiers

NCT02426190

2012-347

Details and patient eligibility

About

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.

Enrollment: 386 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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386 participants in 4 patient groups

Arm 1

Active Comparator group

Description:

Patients in Arm 1 receive standard of care rehabilitation protocol using a recumbent or Nu-step bike during warm-up, followed by individualized therapeutic exercise, and cool-down protocols. The warm-up phase in the study refers to therapeutic exercise. The therapeutic exercise aims to condition and prepare patients for subsequent functional or therapeutic activities. The active comparator (Arm 1) is to ask participants to use modalities, such as a recumbent bike or a Nu-step bike during the warm-up phase of an outpatient physical therapy following a single total knee replacement.

Treatment:

Other: Recumbent or Nu-step bike

Arm 2

Experimental group

Description:

Patients in Arm 2 will use an anti-gravity treadmill (AlterG) during warm-up, followed by individualized therapeutic exercise and cool-down protocols.

Treatment:

Other: Anti-gravity treadmill

Arm 3

Experimental group

Description:

Patients in Arm 3 will use a recumbent or Nu-step bike along with the PENS neuromuscular stimulation modality during warm-up, followed by individualized therapeutic exercise and cool-down protocols.

Treatment:

Other: PENS - neuro-muscular stimulation

Arm 4

Experimental group

Description:

Patients in Arm 4 will use both an anti-gravity treadmill (AlterG) and the PENS neuromuscular stimulation modality during warm-up, followed by individualized therapeutic exercise and cool-down protocols.

Treatment:

Other: Anti-gravity treadmill & PENS - neuro-muscular stimulation