Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change from baseline in gait parameter - speed (m/s) - at 3 months |
The change will be defined by a 10% increase in speed (meters/second) at 3 months from baseline assessment. |
3 months |
|
Primary |
Change from baseline in gait parameter - speed (m/s) - at 6 months |
The change will be defined by a 10% increase in speed (meters/second) at 6 months from baseline assessment. |
6 months |
|
Primary |
Change from baseline in gait parameter - speed (m/s) - at 12 months |
The change will be defined by a 10% increase in speed (meters/second) at 12 months from baseline assessment. |
12 months |
|
Primary |
Change from baseline in gait parameter - step length (m) - at 3 months |
The change will be defined by a 10% increase in step length (meters) at 3 months from baseline assessment. |
3 months |
|
Primary |
Change from baseline in gait parameter - step length (m) - at 6 months |
The change will be defined by a 10% increase in step length (meters) at 6 months from baseline assessment. |
6 months |
|
Primary |
Change from baseline in gait parameter - step length (m) - at 12 months |
The change will be defined by a 10% increase in step length (meters) at 12 months from baseline assessment. |
12 months |
|
Primary |
Change from baseline in gait parameter - step width (m) - at 3 months |
The change will be defined by a 10% decrease in step width (meters) at 3 months from baseline assessment. |
3 months |
|
Primary |
Change from baseline in gait parameter - step width (m) - at 6 months |
The change will be defined by a 10% decrease in step width (meters) at 6 months from baseline assessment. |
6 months |
|
Primary |
Change from baseline in gait parameter - step width (m) - at 12 months |
The change will be defined by a 10% decrease in step width (meters) at 12 months from baseline assessment. |
12 months |
|
Secondary |
Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 3 months |
The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of =2 point in NRPS (range: 0 - 10 points). |
3 months |
|
Secondary |
Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 6 months |
The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of =2 point in NRPS (range: 0 - 10 points). |
6 months |
|
Secondary |
Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 12 months |
The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of =2 point in NRPS (range: 0 - 10 points). |
12 months |
|
Secondary |
Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 3 months |
The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of =27% in ODI (range: 0-50 and higher scores are indicative of more disability). |
3 months |
|
Secondary |
Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 6 months |
The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of =27% in ODI (range: 0-50 and higher scores are indicative of more disability). |
6 months |
|
Secondary |
Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 12 months |
The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of =27% in ODI (range: 0-50 and higher scores are indicative of more disability). |
12 months |
|
Secondary |
Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 3 months |
Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 3 months |
3 months |
|
Secondary |
Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 6 months |
Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 6 months |
6 months |
|
Secondary |
Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 12 months |
Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 12 months |
12 months |
|
Secondary |
Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 3 months |
In the core COMI-back, 1 question consists of 2 numerical rating scales to be answered from 0 to 10 and 5 questions to be answered by selecting 1 of 5 response options. The average of the 2 disability scores forms the disability dimension subscore. A total COMI score is determined by averaging the 5 dimension scores. |
3 months |
|
Secondary |
Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 6 months |
In the core COMI-back, 1 question consists of 2 numerical rating scales to be answered from 0 to 10 and 5 questions to be answered by selecting 1 of 5 response options. The average of the 2 disability scores forms the disability dimension subscore. A total COMI score is determined by averaging the 5 dimension scores. |
6 months |
|
Secondary |
Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 12 months |
In the core COMI-back, 1 question consists of 2 numerical rating scales to be answered from 0 to 10 and 5 questions to be answered by selecting 1 of 5 response options. The average of the 2 disability scores forms the disability dimension subscore. A total COMI score is determined by averaging the 5 dimension scores. |
12 months |
|