Device Requirement | Validation Activity |
1. Device will operate under a maximum angular velocity for the knee joint corresponding to specific gait velocities | User will attempt to exceed maximum angular velocities specified. If maximum angular velocity is exceeded the device will fail the requirement. If the device prevents the user from exceeding the angular velocity the device passes. |
2.1 Device must provide resistance during active flexion 2.2 Device must provide assistance during active extension | User walks with the load cell recording the tension dynamically. The tension will be compared with the joint angles to determine the moments over walking gait |
3. Device must allow normative knee joint angles for the four phases of walking gait | Subject will attempt to move their leg outside of the 65o range of motion. If they move past the 65o range, this fails. If the individual is restrained at 65o, this passes. |
4. Must accommodate the middle 90% of adults 60 years old and up | Conduct a survey asking users the level of comfort experienced while wearing the device. |