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PAS Intervention for Total Knee Replacement (PAS-TKA Trial)
N/A
Waitlist Available
Led By Kelli D Allen, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 6
Awards & highlights
PAS-TKA Trial Summary
This trial is testing whether a physical activity program can help people with new knee implants to improve their activity and movement.
Eligible Conditions
- Total Knee Replacement
- Total Knee Arthroplasty
PAS-TKA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change From Baseline to Month 3 in Objectively Assessed Physical Activity (Accelerometer)
Change From Baseline to Month 3 in Peak Joint Load Symmetry During Walking
Change From Baseline to Month 6 in Objectively Assessed Physical Activity (Accelerometer)
+1 moreSecondary outcome measures
Change From Baseline Month 6 in Self-Reported Physical Activity.
Change From Baseline to Month 3 in Berg Balance Scale
Change From Baseline to Month 3 in Brief Balance Evaluation Systems Test
+13 morePAS-TKA Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Physical Activity and Symmetry (PAS) InterventionExperimental Treatment1 Intervention
Participants assigned to the PAS intervention will receive 4 sessions on balance training and physical activity coaching delivered by a physical therapist, in addition to their usual post-TKA physical therapy (PT) care.
Group II: Attention ControlPlacebo Group1 Intervention
Participants assigned to the ATT group will receive usual post-TKA physical therapy (PT) care, followed by two additional sessions with their physical therapist.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PAS Intervention
2019
N/A
~60
Find a Location
Who is running the clinical trial?
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
484 Previous Clinical Trials
1,086,947 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,190,556 Total Patients Enrolled
Kelli D Allen, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
8 Previous Clinical Trials
1,761 Total Patients Enrolled
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