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SPARTA force plate is used as rehabilitation tool in this study. The device is Force Plate coupled with SPARTA scan software that enables quick assessment of individual movement and balance within minutes. The magnitude as well as efficiency of force production is analyzed to determine an patient recovery graph.
The investigator hope to learn co-relation between the rehab tool and clinical findings and analyse association if any. In this study, force plate is rehab tool, which will optimize care according to the patient's specific needs and provided insights to patients length of stay in the hospital. these data driven insights will be used to observe correlation between machine and clinic data
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | The application used is build upon the company's category-defining, SPARTA Platform and create a platform that streamlines the performance and management of post-acute care physical therapy. The rehab tool will provide us with functional outcome score. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPARTA force plate | Device | The Sparta Platform includes force plate hardware coupled with Sparta Scan software that enables quick assessment of an individual's movement and balance within minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay in Hospital Through Discharge | Length of stay will depend on the score generated by device. | Up to 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Gait Aid Use | The gait aide use ranges in the order of decreasing performance as Nothing > Cane/Walking Sticks > crutch > walker. | Preoperative and month 3 post-surgery |
| Knee Society Score (KSS) |
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Inclusion Criteria:
Exclusion Criteria:
Patients not willing and capable to sign the written informed consent
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| Name | Affiliation | Role |
|---|---|---|
| Derek Amanatullah, M.D. PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
55 participants signed informed consent; 40 were allocated to the study arm
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| ID | Title | Description |
|---|---|---|
| FG000 | Sparta Force Plate | The Sparta platform includes force plate hardware coupled with Sparta Scan software that enables assessment of an individual's movement and balance |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sparta Force Plate | The Sparta platform includes force plate hardware coupled with Sparta Scan software that enables assessment of an individual's movement and balance |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Length of Stay in Hospital Through Discharge | Length of stay will depend on the score generated by device. | Participants with available data are included in the analysis. | Posted | Median | Inter-Quartile Range | days | Up to 8 days |
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Up to 1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sparta Force Plate | The Sparta platform includes force plate hardware coupled with Sparta Scan software that enables assessment of an individual's movement and balance |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Derek F. Amanatullah | Stanford University | (650) 723-2257 | dfa@stanford.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 8, 2021 | Feb 24, 2023 | Prot_000.pdf |
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To assess the effectiveness of the device by calculating Knee Society Score (KSS) at 3 months following surgery. The scale ranges from 0-100 with grading as: Score 80-100 - Excellent; Score 70-79 - Good; Score 60-69 - Fair; Score below 60 - Poor.
| Month 3 post-surgery |
| Range of Motion | To assess the effectiveness of the device by calculating range of motion (extension and flexion). Higher extension scores and lower flexion scores represent greater flexibility. | Preoperative and month 3 post-surgery |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Gait Aid Use | The gait aide use ranges in the order of decreasing performance as Nothing > Cane/Walking Sticks > crutch > walker. | Participants with available data at each time point are included in the analysis. | Posted | Count of Participants | Participants | Preoperative and month 3 post-surgery |
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| Secondary | Knee Society Score (KSS) | To assess the effectiveness of the device by calculating Knee Society Score (KSS) at 3 months following surgery. The scale ranges from 0-100 with grading as: Score 80-100 - Excellent; Score 70-79 - Good; Score 60-69 - Fair; Score below 60 - Poor. | Posted | Mean | Standard Deviation | score on a scale | Month 3 post-surgery |
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| Secondary | Range of Motion | To assess the effectiveness of the device by calculating range of motion (extension and flexion). Higher extension scores and lower flexion scores represent greater flexibility. | Participants with available data at each time point are included in the analysis. | Posted | Mean | Standard Deviation | degrees | Preoperative and month 3 post-surgery |
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| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
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| Month 3 |
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| Flexion - preoperative |
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| Flexion - month 3 |
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