Knee Arthroplasty Rehabilitation Outcomes Study

NCT ID: NCT02426190

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 386 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2017-12-31

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.

Conditions

Total Knee Arthroplasty; Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm 1

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.

Group Type: ACTIVE_COMPARATOR

Recumbent or Nu-step bike

Intervention Type: OTHER

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.

Arm 2

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

Group Type: EXPERIMENTAL

Anti-gravity treadmill

Intervention Type: OTHER

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.

Arm 3

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.

Group Type: EXPERIMENTAL

PENS - neuro-muscular stimulation

Intervention Type: OTHER

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.

Arm 4

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.

Group Type: EXPERIMENTAL

Anti-gravity treadmill & PENS - neuro-muscular stimulation

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MedStar National Rehabilitation Network

OTHER

Sponsor Role: lead

Responsible Party

Jean Hsieh, PhD

Senior Research Associate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michele Vita, DPT

Role: PRINCIPAL_INVESTIGATOR

MedStar National Rehabilitation Network

Locations

MedStar National Rehabilitation Network

Washington D.C., District of Columbia, United States

Countries

United States

References

Hsieh CJ, DeJong G, Vita M, Zeymo A, Desale S. Effect of Outpatient Rehabilitation on Functional Mobility After Single Total Knee Arthroplasty: A Randomized Clinical Trial. JAMA Netw Open. 2020 Sep 1;3(9):e2016571. doi: 10.1001/jamanetworkopen.2020.16571.

Reference Type: DERIVED

PMID: 32940679 (View on PubMed)

DeJong G, Hsieh CJ, Vita MT, Zeymo A, Boucher HR, Thakkar SC. Innovative Devices Did Not Provide Superior Total Knee Arthroplasty Outcomes in Post-Operative Rehabilitation: Results From a Four-Arm Randomized Clinical Trial. J Arthroplasty. 2020 Aug;35(8):2054-2065. doi: 10.1016/j.arth.2020.03.048. Epub 2020 Apr 2.

Reference Type: DERIVED

PMID: 32360105 (View on PubMed)

Other Identifiers

2012-347

Identifier Type: -

Identifier Source: org_study_id