Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Speed |
The BTS G-Walk (BTS Bioengineering S.p.A., GarbagnateMilanese, Italy), a wearable sensor device, will be used to assess gait speed (m/sec) during usual walking condition and fast walking condition through a Bluetooth®3.0 connection (G-Studio®software). |
Change from Baseline at 8 weeks |
|
Primary |
Cadence |
The BTS G-Walk (BTS Bioengineering S.p.A., GarbagnateMilanese, Italy), a wearable sensor device, will be used to assess cadence (steps/min) during the usual walking condition and fast walking condition through a Bluetooth®3.0 connection (G-Studio®software). |
Change from Baseline at 8 weeks |
|
Primary |
Stride length |
The BTS G-Walk (BTS Bioengineering S.p.A., GarbagnateMilanese, Italy), a wearable sensor device, will be used to assess stride length (m) during the usual walking condition and fast walking condition through a Bluetooth®3.0 connection (G-Studio®software). |
Change from Baseline at 8 weeks |
|
Primary |
Step lenght |
The BTS G-Walk (BTS Bioengineering S.p.A., GarbagnateMilanese, Italy), a wearable sensor device, will be used to assess step length (% stride length) during in usual walking condition and fast walking condition through a Bluetooth®3.0 connection (G-Studio®software). |
Change from Baseline at 8 weeks |
|
Primary |
Gait Symmetry |
The BTS G-Walk (BTS Bioengineering S.p.A., GarbagnateMilanese, Italy), a wearable sensor device, will be used to assess gait symmetry. Gait symmetry index of the right and left sides are obtained during walking. The score is calculated by the device as a percentage score out of 100. The higher score indicates more symmetrical gait. |
Change from Baseline at 8 weeks |
|
Primary |
Pelvic angles |
The BTS G-Walk (BTS Bioengineering S.p.A., GarbagnateMilanese, Italy), a wearable sensor device, will be used to assess pelvic movements (tilt (°), obliquity(°), rotation(°)) during gait through a Bluetooth®3.0 connection (G-Studio®software). The device provides the data for these pelvic angles in one single report. |
Change from Baseline at 8 weeks |
|
Primary |
Pelvic symmetry |
The BTS G-Walk (BTS Bioengineering S.p.A., GarbagnateMilanese, Italy), a wearable sensor device, will be used to assess pelvic symmetry (%) during gait through a Bluetooth®3.0 connection (G-Studio®software). The score is calculated by the device as a percentage score out of 100. The higher score indicates more pelvic symmetry. |
Change from Baseline at 8 weeks |
|
Primary |
Postural stability |
A computerized test of the Biodex Balance System will be used to assess postural stability. Subjects will stand on the platform and try to maintain their stability while trying to control their center of pressure which is shown as a point on the screen. The postural stability test assesses the patient's ability to control static balance on a stable platform. The test protocol is performed for 20 seconds with 3 trials. The mean value of the trials is taken as a score. Higher stability index score indicates poor balance and stability. |
Change from Baseline at 8 weeks |
|
Primary |
Limits of stability |
A computerized test of limits of stability will be performed using Biodex Balance System®. Subjects will stand on a stable platform and try to maintain their balance while trying to reach in different directions spot that is shown on the screen. The test results present scores for all directions. Higher scores show better performance (0= worst performance; 100= perfect performance). |
Change from Baseline at 8 weeks |
|
Secondary |
Neck Disability Index |
Neck Disability Index will be used to evaluate the effects of neck pain on functional disability. |
Change from Baseline at 8 weeks |
|
Secondary |
Visual Analog Scale (VAS) |
It consists of a 10 cm horizontal or vertically positioned line on the page. The number '0', which is the starting point on this line, represents the patient's no pain, and the number '10' represents the worst pain experienced by the patient. |
Change from Baseline at 8 weeks |
|
Secondary |
Beck Depression Inventory |
It is designed to measure the severity of depression, to assess changes with treatment, and to identify the disease. |
Change from Baseline at 8 weeks |
|