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| Name | Class |
|---|---|
| Scientific Motion Technologies, Inc. | INDUSTRY |
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This study involves the use of a newly designed shoe device for knee arthritis patients that may help reduce knee pain and improve function.
This study involves the use of a newly designed shoe device for knee arthritis patients that may help reduce knee pain and improve function. This is a 2-phase study designed to evaluate knee pain and function in healthy participants with a history of medial knee arthritis.
The purpose of this study is to evaluate: 1. how using the shoe device will affect a person's walking gait and balance over a single day; and 2. how using the shoe device over the course of a 12-week period will affect a person's walking gait and balance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 Short Term | Experimental | Participants will serve as their own control. Questionnaires and gait measures will be collected during an initial visit using the experimental shoe device. All subjects will perform the same procedures with all the experimental interventions (Sole 1 - Neutral, Sole 1--Offset, Sole 2 - Neutral, Sole 2 - Offset) |
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| Phase 2 Long Term | Experimental | Participants will serve as their own control. Questionnaires, balance, functional and gait measures will be collected during four different visits over a twelve week period (once at baseline visit, 4, 8, and 12 week visits) using the experimental shoe device. Patients will also complete a home walking program using the shoe device over the twelve week period. Subjects will be assigned one of two shoes/soles (either Sole 1-Offset or Sole 2- Offset) for home use. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sole 1 - Neutral | Device | Appropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in arthritic knee patients. The gait-modifying shoes will initially be neutrally aligned to create the smallest amount of instability. This is defined as the location which creates the smallest amount of instability. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in NRS pain (Pain Numeric Rating Scale) score. | Participants selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as one can imagine" or "worst pain imaginable"). | Baseline (Phase 1); Baseline (Phase 2), Week 4, Week 8, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in WOMAC (Western Ontario and McMaster Universities Arthritis Index) score | Self-administered questionnaire consisting of 24 items divided into 3 subscales [total score 0-96; subscales from 0-20 (pain)/0-8(stiffness)/0-68(physical function)]. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). | Baseline (Phase 2), Week 4, Week 8, Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hari K Parvataneni | University of Florida | Principal Investigator |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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Phase 1 All subjects will perform the same procedures with all the experimental interventions (Sole 1 - Neutral, Sole 1--Offset, Sole 2 - Neutral, Sole 2 - Offset)
Phase 2 Subjects will be assigned one of two shoes/soles (either Sole 1-Offset or Sole 2- Offset) for home use.
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| Sole 1 - Offset | Device | Appropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in arthritic knee patients. The offset sole will be placed in a position that may reduce the knee adduction moment. The anterior elements will be placed 1 cm medially from the neutral position and the posterior pod will be moved 1 cm laterally from the neutral position. |
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| Sole 2 - Neutral | Device | Appropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in arthritic knee patients. The gait-modifying shoes will initially be neutrally aligned to create the smallest amount of instability.This is defined as the location which creates the smallest amount of instability. |
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| Sole 2 - Offset | Device | Appropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in arthritic knee patients. The offset sole will be placed in a position that may reduce the knee adduction moment. The anterior elements will be placed 1 cm medially from the neutral position and the posterior pod will be moved 1 cm laterally from the neutral position. |
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| Change in SF-36 disability score. | Eight scaled scores, where each scale is directly transformed into a 0-100 scale. The lower the score the more disability. | Baseline (Phase 2), Week 4, Week 8, Week 12 |
| Change in Timed Up & Go (TUG) Test score. | Time it takes for participant to rise from chair, walk 3 meters, turn around, walk back and sit down. | Baseline (Phase 2), Week 4, Week 8, Week 12 |
| Change in Stair Climb time score. | Time it takes participant to walk up on flight of stairs (12 steps). | Baseline (Phase 2), Week 4, Week 8, Week 12 |