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Improving Physical Activity and Gait Symmetry After Total Knee Arthroplasty

NCT04090125 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-03-05

Study results available
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Summary

The purpose of this pilot study is to examine the effectiveness of the Physical Activity and Symmetry (PAS) program, compared to an attention (ATT)control group, for patients with post-total knee arthroplasty (TKA). The investigators hypothesize that the PAS treatment will result in meaningful improvements in physical activity (PA) and joint loading symmetry compared to the ATT group.

Conditions

  • Knee Replacement, Total
  • Knee Arthroplasty, Total

Interventions

BEHAVIORAL

PAS Intervention

The PAS program will be initiated during the final usual care PT visits. The PAS content will be included within the last two routine PT visits (Sessions 1 and 2). Session 1 will emphasize the importance of PA in TKA recovery, work with participants to establish SMART goals regarding overall PA and provide community-based and other resources to support overall PA. Session 2 will include balance exercise content to improve joint loading symmetry and home exercises will be assigned. Then, PAS participants will receive a follow-up phone call after 4 weeks (to assist with activity progression and problem-solving) and an additional in-person visit after 8 weeks (to visually monitor exercise performance and re-assess proportional weight-bearing ability).

BEHAVIORAL

Attention Control

This will include usual in-person post TKA PT followed by 2 additional contacts (Session 1 and 2) with the physical therapist. Session 1 (phone) will review recovery benchmarks, assessment of participants' daily activities and reminders about symptoms that should trigger contacting a medical professional. Session 2 (in-person) will involve physical performance tests and comparison to appropriate normative values.

Sponsors & Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    collaborator NIH

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Kelli D Allen, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-08
Primary Completion
2023-07-26
Completion
2023-07-26

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04090125 on ClinicalTrials.gov