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The purpose of this study is to:
The study is a pilot study to determine the feasibility of a full trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical Therapy Rehab and Fitbit® | Experimental | Standard outpatient physical therapy rehabilitation after total knee replacement with the addition of a Fitbit® to promote physical activity. |
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| Physical Therapy Rehab | Active Comparator | Standard outpatient physical therapy rehabilitation after total knee replacement. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fitbit® | Behavioral | Participants can read how many steps/day they walked on the Fitbit® daily. The treating physical therapist reviews Fitbit® recorded steps from the previous week and together with the patient sets a new step goal. The physical therapist discusses barriers to meeting step goals are discussed. Self-reward for meeting step/goal is set weekly. Participants in this group will also receive 1-month phone calls for 6-months after completing physical therapy rehabilitation to discuss physical activity, set monthly step count goal, barriers to overcoming goal and to continue to develop a reward system for when the participant achieves their step count goal. |
| Measure | Description | Time Frame |
|---|---|---|
| Physical activity measured by the Actigraph GT3X monitor | This time frame is open-ended by design. The goal is to model current physical therapy practice, in which a patient after total knee replacement goes to outpatient physical therapy and receives physical therapy services based on a timeframe planned out by their treating physical therapist. Treatment is then discontinued based on the patient's clinical presentation (ie functional mobility, strength gains, range of motion gains, patient specific goals, etc). | Initial physical therapy evaluation to discharge from outpatient physical therapy rehab which is expected to be 8 weeks. Also at 6-months and 12-months from discharge from physical therapy rehab. |
| Measure | Description | Time Frame |
|---|---|---|
| Short term adherence to treatment as measured by physical therapist. | This time frame is open-ended by design. The goal is to model current physical therapy practice, in which a patient after total knee replacement goes to outpatient physical therapy and receives physical therapy services based on a timeframe planned out by their treating physical therapist. Treatment is then discontinued based on the patient's clinical presentation (ie functional mobility, strength gains, range of motion gains, patient specific goals, etc). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel K White, PT, ScD, MSc | University of Delaware | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Delaware | Newark | Delaware | 19713 | United States |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Physical Therapy Rehab | Other | Standard of care physical therapy after total knee replacement. The goals of physical therapy are to increase knee range of motion and strength, improve balance and agility, and increase daily walking. Physical therapy appointment times range from 45-60 minutes with appointments occurring 2 times a week for 6-8 weeks. |
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| Initial physical therapy evaluation to discharge from outpatient physical therapy rehab which is expected to be 8 weeks. |
| Self report long-term adherence to treatment as measured by research assistant. | This time frame is open-ended by design. The goal is to model current physical therapy practice, in which a patient after total knee replacement goes to outpatient physical therapy and receives physical therapy services based on a timeframe planned out by their treating physical therapist. Treatment is then discontinued based on the patient's clinical presentation (ie functional mobility, strength gains, range of motion gains, patient specific goals, etc). | 6 months after discharge from physical therapy rehab |
| Reporting of adverse events | This time frame is open-ended by design. The goal is to model our trial off of current physical therapy practice, in which a patient after total knee replacement goes to outpatient physical therapy and receives physical therapy services based on a timeframe planned out by their treating physical therapist. Treatment is then discontinued based on the patient's clinical presentation (ie functional mobility, strength gains, range of motion gains, patient specific goals, etc). | Initial physical therapy evaluation to discharge from outpatient physical therapy rehab which is expected to be 8 weeks. |
| Number participants excluded from study as measured by research assistant. | Number of participants that do not meet inclusion criteria. | At initial physical therapy evaluation. |
| Reason why the participant was excluded from the study. | Categories: 1) no time/too busy 2) too much trouble 3) illness (self) 4) illness family 5) not interested 6) concerned about injury/pain 7) concerned about quality of care 8) refused | At initial physical therapy evaluation. |
| Self reported kinesiophobia using the Tampa-15 Scale for Kinesiophobia. | This time frame is open-ended by design. The goal is to model current physical therapy practice, in which a patient after total knee replacement goes to outpatient physical therapy and receives physical therapy services based on a timeframe planned out by their treating physical therapist. Treatment is then discontinued based on the patient's clinical presentation (ie functional mobility, strength gains, range of motion gains, patient specific goals, etc). | Initial physical therapy evaluation to discharge from outpatient physical therapy rehab which is expected to be 8 weeks. |
| Self reported self-efficacy using the Self-Efficacy Scale for Exercise. | This time frame is open-ended by design. The goal is to model current physical therapy practice, in which a patient after total knee replacement goes to outpatient physical therapy and receives physical therapy services based on a timeframe planned out by their treating physical therapist. Treatment is then discontinued based on the patient's clinical presentation (ie functional mobility, strength gains, range of motion gains, patient specific goals, etc). | Initial physical therapy evaluation to discharge from outpatient physical therapy rehab which is expected to be 8 weeks. |
| Intervention Fidelity using electronic medical records and digital audio recordings. | The goal is to investigate how consistent the physical activity intervention is provided to the patients. Consistency will be measured using two methods. The first is to use the EMR to check if current steps/day were recorded by the treating PT. The second is to use the digital audio recording in a subset of patients to evaluate if steps/day from the past week were reviewed by the treating PT, and if a step goal was discussed for the next week. This time frame is open-ended by design. The goal is to model current physical therapy practice, in which a patient after total knee replacement goes to outpatient physical therapy and receives physical therapy services based on a timeframe planned out by their treating physical therapist. Treatment is then discontinued based on the patient's clinical presentation (ie functional mobility, strength gains, range of motion gains, patient specific goals, etc). | During outpatient physical therapy rehab which is expected to be 8 weeks. |
| Self reported pain catastrophizing using the Pain Catastrophizing Scale (PSC) | This time frame is open-ended by design. Our goal is to model current physical therapy practice, in which a patient after total knee replacement goes to outpatient physical therapy and receives physical therapy services based on a timeframe planned out by their treating physical therapist. Treatment is then discontinued based on the patient's clinical presentation (ie functional mobility, strength gains, range of motion gains, patient specific goals, etc). | Initial physical therapy evaluation to discharge from outpatient physical therapy rehab which is expected to be 8 weeks. |