Knee Arthroplasty Rehabilitation Outcomes Study

NCT02426190 | Completed

• 1 other identifier: 2012-347
• Study Type: interventional
• Target: 386
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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)

Study Arms (4)

Arm 1

ACTIVE COMPARATOR

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.

Other: Recumbent or Nu-step bike

Arm 2

EXPERIMENTAL

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

Other: Anti-gravity treadmill

Arm 3

EXPERIMENTAL

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.

Other: PENS - neuro-muscular stimulation

Arm 4

EXPERIMENTAL

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.

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

Interventions

Anti-gravity treadmill 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 2

PENS - neuro-muscular stimulation 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 3

Anti-gravity treadmill & PENS - neuro-muscular stimulation 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.

Arm 4

Recumbent or Nu-step bike 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 1

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MedStar National Rehabilitation Network: lead

Study Sites (1)

MedStar National Rehabilitation Network

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (2)

• 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.

  PMID: 32940679 DERIVED

• 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.

  PMID: 32360105 DERIVED

Study Officials

• Michele Vita, DPT

  MedStar National Rehabilitation Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Associate

Study Record Dates

• First Submitted: April 8, 2015
• First Posted: April 24, 2015
• Study Start: October 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 31, 2017
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

US (1)