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funding halted
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This is the research study of a rehabilitation tool that informs, guides and empowers clinicians to care for their patients. We hope to learn ways to improve patient outcomes, reduce costs and increase value to the healthcare system
The investigator hope to learn co-relation between the rehab tool and clinical findings and analyse association if any. Rehab tool 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, FDA- cleared Virtual Exercise Rehabilitation Assistant (VERA™) 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 |
|---|---|---|---|---|
| VERA clinic | Device | A software system used with the Microsoft Kinect intended to support the physical rehabilitation of adults in the clinic and at home. |
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| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay in Hospital Through Discharge | Up to 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Requiring Gait Aid Use | The gait aide use ranges in the order of decreasing performance as Nothing > Cane > crutch > walker. | 3 months post operative visit |
| Knee Society Score (KSS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford outpatient center | Redwood City | California | 94063 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental | Participants utilize FDA cleared Virtual Exercise Rehabilitation Assistant (VERA™) platform during pre-operative visit to obtain functional outcome scores. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | Participants utilize the VERA platform during pre-operative visit to obtain functional outcome scores. |
| 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, Categorical | Count of Participants |
| 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 | Posted | Median | Inter-Quartile Range | days | Up to 2 days |
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3 months
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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 | Experimental | Participants utilize the VERA platform during pre-operative visit to obtain functional outcome scores. |
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The study terminated early and did not meet its planned enrollment size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Derek Amanatullah, MD, PhD | 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 | May 3, 2019 | May 24, 2022 | Prot_000.pdf |
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To assess the effectiveness of the device by calculating knee society score (KSS) after 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
| 3 months post operative visit |
| Knee Range of Motion | To assess the effectiveness of the device by calculating range of motion (maximum degrees) | 3 months post operative visit |
| Participants |
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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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| Gait aide use | The gait aide use ranges in the order of decreasing performance as Nothing > Cane > crutch > walker. | Count of Participants | Participants |
|
| Range of motion ( maximum degrees) | Mean | Standard Deviation | degrees |
|
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| Secondary | Number of Participants Requiring Gait Aid Use | The gait aide use ranges in the order of decreasing performance as Nothing > Cane > crutch > walker. | Posted | Count of Participants | Participants | 3 months post operative visit |
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| Secondary | Knee Society Score (KSS) | To assess the effectiveness of the device by calculating knee society score (KSS) after 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 | Count of Participants | Participants | 3 months post operative visit |
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| Secondary | Knee Range of Motion | To assess the effectiveness of the device by calculating range of motion (maximum degrees) | Posted | Mean | Standard Deviation | degrees | 3 months post operative visit |
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| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
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| Walker |
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| Measurements |
|---|
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| Poor ( below 60) |
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