Knee Arthroplasty, Total Clinical Trial
— PAS-TKAOfficial title:
Improving Physical Activity and Gait Symmetry After Total Knee Arthroplasty
Verified date | December 2022 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | July 26, 2023 |
Est. primary completion date | July 26, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients receiving post-total knee arthroplasty (TKA) physical therapy (PT) at a University of North Carolina (UNC) Healthcare System clinic Exclusion Criteria: - significant cognitive impairment - neurological disorders affecting gait - systemic rheumatic disease - hospitalization for a cardiovascular condition the past six months - psychosis - substance abuse disorder - lower extremity surgery in the past year - any other health conditions determined to be contraindications to a home exercise program |
Country | Name | City | State |
---|---|---|---|
United States | UNC Thurston Arthritis Research Center | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline to Month 3 in Objectively Assessed Physical Activity (Accelerometer) | Minutes of moderate to vigorous intensity PA (MVPA) per week measured via accelerometer.
A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here. |
Baseline, Month 3 | |
Primary | Change From Baseline to Month 6 in Objectively Assessed Physical Activity (Accelerometer) | Minutes of moderate to vigorous intensity PA (MVPA) per week measured via accelerometer.
A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here. |
Baseline, Month 6 | |
Primary | Change From Baseline to Month 3 in Peak Joint Load Symmetry During Walking | Participants will complete a 10 meter walking test while load beneath each foot is recorded using an instrumented insole. Loading symmetry (peak ground reaction force) will be assessed using the limb symmetry index (LSI (|Surgical/Non-Surgical|*100), values lower than 100% indicate less loading of the surgical limb.
A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here. |
Baseline, Month 3 | |
Primary | Change From Baseline to Month 6 in Peak Joint Load Symmetry During Walking | Participants will complete a 10 meter walking test while load beneath each foot is recorded using an instrumented insole. Loading symmetry (peak ground reaction force) will be assessed using the limb symmetry index (LSI (|Surgical/Non-Surgical|*100), values lower than 100% indicate less loading of the surgical limb.
A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here. |
Baseline, Month 6 | |
Secondary | Change From Baseline to Month 3 in Self-Reported Physical Activity. | Self-Reported Physical Activity will be assessed using the Modified version of the CHAMPS (Community Health Activities Model Program for Seniors) Physical Activity Measure. Data from the questionnaire is used to determine variety, frequency, and minutes per week from physical activity. This outcome pertains to minutes of physical activity of moderate or greater intensity (metabolic equivalents = 3.0). A square root transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here. | Baseline, Month 3 | |
Secondary | Change From Baseline Month 6 in Self-Reported Physical Activity. | Self-Reported Physical Activity will be assessed using the Modified version of the CHAMPS (Community Health Activities Model Program for Seniors) Physical Activity Measure. Data from the questionnaire is used to determine variety, frequency, and minutes per week from physical activity. This outcome pertains to minutes of physical activity of moderate or greater intensity (metabolic equivalents = 3.0). A square root transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here. | Baseline to Month 6 | |
Secondary | Change From Baseline to Month 3 in Steps Per Day | Step counts measured via accelerometer. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here. | Baseline, Month 3 | |
Secondary | Change From Baseline to Month 6 in Steps Per Day | Step counts measured via accelerometer. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here. | Baseline, Month 6 | |
Secondary | Change From Baseline to Month 3 in Minutes of Any Physical Activity (PA) | Minutes of any PA measured via accelerometer. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here. | Baseline, Month 3 | |
Secondary | Change From Baseline to Month 6 in Minutes of Any Physical Activity (PA) | Minutes of any PA measured via accelerometer. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here. | Baseline, Month 6 | |
Secondary | Change From Baseline to Month 3 in Sedentary Minutes | Minutes of sedentary activity per day, measured via accelerometer | Baseline, Month 3 | |
Secondary | Change From Baseline to Month 6 in Sedentary Minutes | Minutes of sedentary activity per day, measured via accelerometer | Baseline, Month 6 | |
Secondary | Change From Baseline to Month 3 in Berg Balance Scale | Berg Balance Scale includes 14 tests of static and dynamic balance. Each item is scored along a 5-point scale, ranging from 0 to 4. Zero indicates the lowest level of function and 4 the highest level of function. The total score ranges from 0 to 56. Lower scores indicate reduced functional mobility. | Baseline, Month 3 | |
Secondary | Change From Baseline to Month 6 in Berg Balance Scale | Berg Balance Scale includes 14 tests of static and dynamic balance. Each item is scored along a 5-point scale, ranging from 0 to 4. Zero indicates the lowest level of function and 4 the highest level of function. The total score ranges from 0 to 56. Lower scores indicate reduced functional mobility. | Baseline, Month 6 | |
Secondary | Change From Baseline to Month 3 in Brief Balance Evaluation Systems Test | Brief Balance Evaluation Systems includes 8 tasks across 6 domains. Each item is scored: 0-3 points (0 representing severe impairment and 3 representing no balance impairment), score range is 0-24). Lower scores indicate higher levels of balance impairment. | Baseline, Month 3 | |
Secondary | Change From Baseline to Month 6 in Brief Balance Evaluation Systems Test | Brief Balance Evaluation Systems includes 8 tasks across 6 domains. Each item is scored: 0-3 points (0 representing severe impairment and 3 representing no balance impairment), score range is 0-24. Lower scores indicate higher levels of balance impairment. | Baseline, Month 6 | |
Secondary | Change From Baseline to Month 3 in Knee Injury and Osteoarthritis Outcome Score (KOOS) | The KOOS is a patient-reported outcome measurement instrument, developed to assess the patient's opinion about their knee and associated problems. Five KOOS subscale scores were administered: Pain (9 items), Symptoms (7 items), Function in daily living (17 items), Function in Sport and Recreation (5 items), and knee-related Quality of Life (4 items). All items are scored on 5-point Likert scales. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. | Baseline, Month 3 | |
Secondary | Change From Baseline to Month 6 in Knee Injury and Osteoarthritis Outcome Score (KOOS) | The KOOS is a patient-reported outcome measurement instrument, developed to assess the patient's opinion about their knee and associated problems. Five KOOS subscale scores were administered: Pain (9 items), Symptoms (7 it4ems) Function in daily living (17 items), Function in Sport and Recreation (5 items), and knee-related Quality of Life (4 items). All items are scored on 5-point Likert scales. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. | Baseline, Month 6 | |
Secondary | Change From Baseline to Month 3 in Tampa Scale for Kinesiophobia | The Tampa Scale of Kinesiophobia is a 17 item scale for assessing fear of movement. The scale specifically assesses activity avoidance due to pain-related fear of movement. All items are measured on a 4-point scale from "strongly agree" to "strongly disagree." A score of 17 is the lowest possible score, and indicates no kinesiophobia or negligible. A score of 68 is the highest possible score and indicates extreme fear of pain with movement. | Baseline, Month 3 | |
Secondary | Change From Baseline to Month 6 in Tampa Scale for Kinesiophobia | The Tampa Scale of Kinesiophobia is a 17 item scale for assessing fear of movement. The scale specifically assesses activity avoidance due to pain-related fear of movement. All items are measured on a 4-point scale from "strongly agree" to "strongly disagree." A score of 17 is the lowest possible score, and indicates no kinesiophobia or negligible. A score of 68 is the highest possible score and indicates extreme fear of pain with movement. | Baseline, Month 6 |
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