Trial Outcomes & Findings for Improving Spine Surgical Care With Real-Time Objective Patient Tracking Using the Apple Watch (NCT NCT04379921)
NCT ID: NCT04379921
Last Updated: 2025-12-19
Results Overview
Steps and distance (meters) collected by Apple Watch were averaged across the outcome measure time frame. Survey scores were collected at the end of the outcome measure time frame. * Short Form-36 (SF-36): Scores range from 0 to 100. Higher scores indicate better health outcomes. * EuroQOL-5 Dimensional Questionnaire (EQ-5D): Scores range from 0 to 100. Higher scores indicate better health outcomes. * Patient-Reported Outcomes Measurement Information System (PROMIS): Scores range from 41 to 78.3. Higher scores indicate worse health outcomes. * Neck Disability Index (NDI): Scores range from 0 to 100. Higher scores indicate worse health outcomes. * Oswestry Disability Index (ODI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.
COMPLETED
NA
255 participants
2-6 weeks pre-operatively
2025-12-19
Participant Flow
Participant milestones
| Measure |
Control
Participants receive standard care.
|
Apple Watch and App
Participants receive standard care, and an Apple Watch to record activity through the NeuroCoach App, recording patient's mobility information (e.g., step counts, heart rate, stairs climbed, distance traveled) as well as provide an additional platform for patients to complete questionnaires.
|
|---|---|---|
|
Overall Study
STARTED
|
122
|
133
|
|
Overall Study
COMPLETED
|
96
|
96
|
|
Overall Study
NOT COMPLETED
|
26
|
37
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Spine Surgical Care With Real-Time Objective Patient Tracking Using the Apple Watch
Baseline characteristics by cohort
| Measure |
Control
n=91 Participants
Participants receive standard care.
|
Apple Watch and App
n=96 Participants
Participants receive standard care, and an Apple Watch to record activity through the NeuroCoach App.
|
Total
n=187 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Region of Enrollment
United States
|
91 Participants
n=8 Participants
|
96 Participants
n=6 Participants
|
187 Participants
n=6 Participants
|
|
Age, Continuous
|
59.03 years
STANDARD_DEVIATION 13.22 • n=8 Participants
|
61.79 years
STANDARD_DEVIATION 13.28 • n=6 Participants
|
60.46 years
STANDARD_DEVIATION 13.29 • n=6 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=8 Participants
|
58 Participants
n=6 Participants
|
108 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=8 Participants
|
38 Participants
n=6 Participants
|
79 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=8 Participants
|
6 Participants
n=6 Participants
|
13 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=8 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Hispanic and Asian
|
2 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Hispanic and Latino
|
5 Participants
n=8 Participants
|
7 Participants
n=6 Participants
|
12 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiians and Other Pacific Islanders
|
0 Participants
n=8 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=8 Participants
|
8 Participants
n=6 Participants
|
15 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
White
|
67 Participants
n=8 Participants
|
67 Participants
n=6 Participants
|
134 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
White and Hispanic
|
2 Participants
n=8 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
White and Native American
|
0 Participants
n=8 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: 2-6 weeks pre-operativelyPopulation: Participants with data for the respective time frame and patient-reported outcome. This outcome was evaluated on the Apple Watch and App group only (the Control group was not assigned an Apple Watch).
Steps and distance (meters) collected by Apple Watch were averaged across the outcome measure time frame. Survey scores were collected at the end of the outcome measure time frame. * Short Form-36 (SF-36): Scores range from 0 to 100. Higher scores indicate better health outcomes. * EuroQOL-5 Dimensional Questionnaire (EQ-5D): Scores range from 0 to 100. Higher scores indicate better health outcomes. * Patient-Reported Outcomes Measurement Information System (PROMIS): Scores range from 41 to 78.3. Higher scores indicate worse health outcomes. * Neck Disability Index (NDI): Scores range from 0 to 100. Higher scores indicate worse health outcomes. * Oswestry Disability Index (ODI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.
Outcome measures
| Measure |
Apple Watch and App
n=90 Participants
Participants receive standard care, and an Apple Watch to record activity through the NeuroCoach App.
|
Apple Watch and App
Participants receive standard care, and an Apple Watch to record activity through the NeuroCoach App.
|
|---|---|---|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Steps to EQ-5D
|
0.170547163 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Steps to ODI
|
-0.245495419 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Distance traveled (meters) to SF-36
|
0.156072138 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Distance traveled (meters) to EQ-5D
|
0.165543596 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Steps to PROMIS
|
0.03133065 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Steps to NDI
|
-0.287227624 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Distance traveled (meters) to PROMIS
|
0.047067760 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Distance traveled (meters) to NDI
|
-0.288155169 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Distance traveled (meters) to ODI
|
-0.238599412 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Steps to SF-36
|
0.160804476 correlation coefficient
|
—
|
PRIMARY outcome
Timeframe: 4-6 weeks post-operativelyPopulation: Participants with data for the respective time frame and patient-reported outcome. This outcome was evaluated on the Apple Watch and App group only (the Control group was not assigned an Apple Watch).
Steps and distance (meters) collected by Apple Watch were averaged across the outcome measure time frame. Survey scores were collected at the end of the outcome measure time frame. * Short Form-36 (SF-36): Scores range from 0 to 100. Higher scores indicate better health outcomes. * EuroQOL-5 Dimensional Questionnaire (EQ-5D): Scores range from 0 to 100. Higher scores indicate better health outcomes. * Patient-Reported Outcomes Measurement Information System (PROMIS): Scores range from 41 to 78.3. Higher scores indicate worse health outcomes. * Neck Disability Index (NDI): Scores range from 0 to 100. Higher scores indicate worse health outcomes. * Oswestry Disability Index (ODI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.
Outcome measures
| Measure |
Apple Watch and App
n=88 Participants
Participants receive standard care, and an Apple Watch to record activity through the NeuroCoach App.
|
Apple Watch and App
Participants receive standard care, and an Apple Watch to record activity through the NeuroCoach App.
|
|---|---|---|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Steps to SF-36
|
0.237509597 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Steps to EQ-5D
|
0.254596876 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Steps to PROMIS
|
-0.061318768 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Steps to NDI
|
-0.026754947 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Steps to ODI
|
-0.237678247 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Distance traveled (meters) to SF-36
|
0.251030049 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Distance traveled (meters) to EQ-5D
|
0.249053662 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Distance traveled (meters) to PROMIS
|
-0.044081635 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Distance traveled (meters) to NDI
|
-0.047181840 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Distance traveled (meters) to ODI
|
-0.234325616 correlation coefficient
|
—
|
PRIMARY outcome
Timeframe: 6 weeks-3 months post-operativelyPopulation: Participants with data for the respective time frame and patient-reported outcome. This outcome was evaluated on the Apple Watch and App group only (the Control group was not assigned an Apple Watch).
Steps and distance (meters) collected by Apple Watch were averaged across the outcome measure time frame. Survey scores were collected at the end of the outcome measure time frame. * Short Form-36 (SF-36): Scores range from 0 to 100. Higher scores indicate better health outcomes. * EuroQOL-5 Dimensional Questionnaire (EQ-5D): Scores range from 0 to 100. Higher scores indicate better health outcomes. * Patient-Reported Outcomes Measurement Information System (PROMIS): Scores range from 41 to 78.3. Higher scores indicate worse health outcomes. * Neck Disability Index (NDI): Scores range from 0 to 100. Higher scores indicate worse health outcomes. * Oswestry Disability Index (ODI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.
Outcome measures
| Measure |
Apple Watch and App
n=85 Participants
Participants receive standard care, and an Apple Watch to record activity through the NeuroCoach App.
|
Apple Watch and App
Participants receive standard care, and an Apple Watch to record activity through the NeuroCoach App.
|
|---|---|---|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Steps to SF-36
|
0.211745206 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Steps to EQ-5D
|
0.137757731 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Steps to PROMIS
|
-0.028651640 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Steps to NDI
|
-0.195235044 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Steps to ODI
|
-0.130278276 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Distance traveled (meters) to SF-36
|
0.205169697 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Distance traveled (meters) to EQ-5D
|
0.122267044 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Distance traveled (meters) to PROMIS
|
-0.004087870 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Distance traveled (meters) to NDI
|
-0.195274715 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Distance traveled (meters) to ODI
|
-0.102500089 correlation coefficient
|
—
|
PRIMARY outcome
Timeframe: 3-6 months post-operativelyPopulation: Participants with data for the respective time frame and patient-reported outcome. This outcome was evaluated on the Apple Watch and App group only (the Control group was not assigned an Apple Watch).
Steps and distance (meters) collected by Apple Watch were averaged across the outcome measure time frame. Survey scores were collected at the end of the outcome measure time frame. * Short Form-36 (SF-36): Scores range from 0 to 100. Higher scores indicate better health outcomes. * EuroQOL-5 Dimensional Questionnaire (EQ-5D): Scores range from 0 to 100. Higher scores indicate better health outcomes. * Patient-Reported Outcomes Measurement Information System (PROMIS): Scores range from 41 to 78.3. Higher scores indicate worse health outcomes. * Neck Disability Index (NDI): Scores range from 0 to 100. Higher scores indicate worse health outcomes. * Oswestry Disability Index (ODI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.
Outcome measures
| Measure |
Apple Watch and App
n=77 Participants
Participants receive standard care, and an Apple Watch to record activity through the NeuroCoach App.
|
Apple Watch and App
Participants receive standard care, and an Apple Watch to record activity through the NeuroCoach App.
|
|---|---|---|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Steps to SF-36
|
0.299619225 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Steps to EQ-5D
|
0.313524073 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Steps to PROMIS
|
-0.086753507 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Steps to NDI
|
-0.239505761 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Steps to ODI
|
-0.322504210 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Distance traveled (meters) to SF-36
|
0.293769111 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Distance traveled (meters) to EQ-5D
|
0.308525815 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Distance traveled (meters) to PROMIS
|
-0.067371364 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Distance traveled (meters) to NDI
|
-0.234173267 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Distance traveled (meters) to ODI
|
-0.325285216 correlation coefficient
|
—
|
PRIMARY outcome
Timeframe: 6-12 months post-operativelyPopulation: Participants with data for the respective time frame and patient-reported outcome. This outcome was evaluated on the Apple Watch and App group only (the Control group was not assigned an Apple Watch).
Steps and distance (meters) collected by Apple Watch were averaged across the outcome measure time frame. Survey scores were collected at the end of the outcome measure time frame. * Short Form-36 (SF-36): Scores range from 0 to 100. Higher scores indicate better health outcomes. * EuroQOL-5 Dimensional Questionnaire (EQ-5D): Scores range from 0 to 100. Higher scores indicate better health outcomes. * Patient-Reported Outcomes Measurement Information System (PROMIS): Scores range from 41 to 78.3. Higher scores indicate worse health outcomes. * Neck Disability Index (NDI): Scores range from 0 to 100. Higher scores indicate worse health outcomes. * Oswestry Disability Index (ODI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.
Outcome measures
| Measure |
Apple Watch and App
n=73 Participants
Participants receive standard care, and an Apple Watch to record activity through the NeuroCoach App.
|
Apple Watch and App
Participants receive standard care, and an Apple Watch to record activity through the NeuroCoach App.
|
|---|---|---|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Steps to SF-36
|
0.093993286 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Steps to EQ-5D
|
0.144224016 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Steps to PROMIS
|
-0.094520314 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Steps to NDI
|
0.055377523 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Steps to ODI
|
-0.257180828 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Distance traveled (meters) to SF-36
|
0.058395557 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Distance traveled (meters) to EQ-5D
|
0.153422291 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Distance traveled (meters) to PROMIS
|
-0.109789378 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Distance traveled (meters) to NDI
|
0.027880729 correlation coefficient
|
—
|
|
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
Distance traveled (meters) to ODI
|
-0.202307765 correlation coefficient
|
—
|
PRIMARY outcome
Timeframe: 2-6 weeks pre-operatively; 4-6 weeks, 6 weeks-3 months, 3-6 months, and 6-12 months post-operativelyPopulation: Participants with available data at the respective time point. This outcome was evaluated on the Apple Watch and App group only (the Control group was not assigned an Apple Watch).
Steps per day collected by Apple Watch were averaged across the respective outcome measure time frame. Change was calculated as the post-baseline value minus the baseline value (which was normalized to zero).
Outcome measures
| Measure |
Apple Watch and App
n=88 Participants
Participants receive standard care, and an Apple Watch to record activity through the NeuroCoach App.
|
Apple Watch and App
Participants receive standard care, and an Apple Watch to record activity through the NeuroCoach App.
|
|---|---|---|
|
Change in Objective Outcome Measures: Number of Steps After Surgery
4-6 weeks post-operatively
|
-1166.04 steps per day
Standard Deviation 2272.07
|
—
|
|
Change in Objective Outcome Measures: Number of Steps After Surgery
6 weeks-3 months post-operatively
|
764.68 steps per day
Standard Deviation 2066.11
|
—
|
|
Change in Objective Outcome Measures: Number of Steps After Surgery
3-6 months post-operatively
|
1212.10 steps per day
Standard Deviation 2177.45
|
—
|
|
Change in Objective Outcome Measures: Number of Steps After Surgery
6-12 months post-operatively
|
1068.73 steps per day
Standard Deviation 2048.83
|
—
|
PRIMARY outcome
Timeframe: 2-6 weeks pre-operatively; 4-6 weeks, 6 weeks-3 months, 3-6 months, and 6-12 months post-operativelyPopulation: Participants with available data at the respective time point. This outcome was evaluated on the Apple Watch and App group only (the Control group was not assigned an Apple Watch).
Meters per day collected by Apple Watch were averaged across the respective outcome measure time frame. Change was calculated as the post-baseline value minus the baseline value (which was normalized to zero).
Outcome measures
| Measure |
Apple Watch and App
n=88 Participants
Participants receive standard care, and an Apple Watch to record activity through the NeuroCoach App.
|
Apple Watch and App
Participants receive standard care, and an Apple Watch to record activity through the NeuroCoach App.
|
|---|---|---|
|
Change in Objective Outcome Measures: Distance Traveled (Meters) After Surgery
4-6 weeks post-operatively
|
-792.29 meters per day
Standard Deviation 1586.98
|
—
|
|
Change in Objective Outcome Measures: Distance Traveled (Meters) After Surgery
3 months post-operatively
|
591.27 meters per day
Standard Deviation 1502.72
|
—
|
|
Change in Objective Outcome Measures: Distance Traveled (Meters) After Surgery
6 months post-operatively
|
915.26 meters per day
Standard Deviation 1584.86
|
—
|
|
Change in Objective Outcome Measures: Distance Traveled (Meters) After Surgery
12 months post-operatively
|
858.99 meters per day
Standard Deviation 1705.98
|
—
|
PRIMARY outcome
Timeframe: 2-6 weeks pre-operativelyPopulation: Participants with available data. This outcome was evaluated on the Apple Watch and App group only (the Control group was not assigned an Apple Watch).
Average hours wear time per day across the outcome measure time frame.
Outcome measures
| Measure |
Apple Watch and App
n=90 Participants
Participants receive standard care, and an Apple Watch to record activity through the NeuroCoach App.
|
Apple Watch and App
Participants receive standard care, and an Apple Watch to record activity through the NeuroCoach App.
|
|---|---|---|
|
Patient Compliance With Wearing Apple Watch - Wear Time
|
14.05 hours per day
Standard Deviation 3.0
|
—
|
PRIMARY outcome
Timeframe: 4-6 weeks post-operativelyPopulation: Participants with available data. This outcome was evaluated on the Apple Watch and App group only (the Control group was not assigned an Apple Watch).
Average hours wear time per day across the outcome measure time frame.
Outcome measures
| Measure |
Apple Watch and App
n=88 Participants
Participants receive standard care, and an Apple Watch to record activity through the NeuroCoach App.
|
Apple Watch and App
Participants receive standard care, and an Apple Watch to record activity through the NeuroCoach App.
|
|---|---|---|
|
Patient Compliance With Wearing Apple Watch - Wear Time
|
14.26 hours per day
Standard Deviation 3.37
|
—
|
PRIMARY outcome
Timeframe: 6 weeks-3 months post-operativelyPopulation: Participants with available data. This outcome was evaluated on the Apple Watch and App group only (the Control group was not assigned an Apple Watch).
Average hours wear time per day across the outcome measure time frame.
Outcome measures
| Measure |
Apple Watch and App
n=85 Participants
Participants receive standard care, and an Apple Watch to record activity through the NeuroCoach App.
|
Apple Watch and App
Participants receive standard care, and an Apple Watch to record activity through the NeuroCoach App.
|
|---|---|---|
|
Patient Compliance With Wearing Apple Watch - Wear Time
|
14.47 hours per day
Standard Deviation 3.63
|
—
|
PRIMARY outcome
Timeframe: 3-6 months post-operativelyPopulation: Participants with available data. This outcome was evaluated on the Apple Watch and App group only (the Control group was not assigned an Apple Watch).
Average hours wear time per day across the outcome measure time frame.
Outcome measures
| Measure |
Apple Watch and App
n=77 Participants
Participants receive standard care, and an Apple Watch to record activity through the NeuroCoach App.
|
Apple Watch and App
Participants receive standard care, and an Apple Watch to record activity through the NeuroCoach App.
|
|---|---|---|
|
Patient Compliance With Wearing Apple Watch - Wear Time
|
14.49 hours per day
Standard Deviation 3.3
|
—
|
PRIMARY outcome
Timeframe: 6-12 months post-operativelyPopulation: Participants with available data. This outcome was evaluated on the Apple Watch and App group only (the Control group was not assigned an Apple Watch).
Average hours wear time per day across the outcome measure time frame.
Outcome measures
| Measure |
Apple Watch and App
n=73 Participants
Participants receive standard care, and an Apple Watch to record activity through the NeuroCoach App.
|
Apple Watch and App
Participants receive standard care, and an Apple Watch to record activity through the NeuroCoach App.
|
|---|---|---|
|
Patient Compliance With Wearing Apple Watch - Wear Time
|
14.15 hours per day
Standard Deviation 3.62
|
—
|
PRIMARY outcome
Timeframe: 6 weeks post-operativelyPopulation: Participants who completed the survey at this time point
Reported as the number of participants, by response category.
Outcome measures
| Measure |
Apple Watch and App
n=91 Participants
Participants receive standard care, and an Apple Watch to record activity through the NeuroCoach App.
|
Apple Watch and App
n=84 Participants
Participants receive standard care, and an Apple Watch to record activity through the NeuroCoach App.
|
|---|---|---|
|
Patient Satisfaction With Their Spine Care
Extremely satisfied
|
63 Participants
|
51 Participants
|
|
Patient Satisfaction With Their Spine Care
Very satisfied
|
6 Participants
|
7 Participants
|
|
Patient Satisfaction With Their Spine Care
Somewhat satisfied
|
20 Participants
|
23 Participants
|
|
Patient Satisfaction With Their Spine Care
Neutral
|
2 Participants
|
2 Participants
|
|
Patient Satisfaction With Their Spine Care
Not at all satisfied
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 3 months post-operativelyPopulation: Participants who completed the survey at this time point
Reported as the number of participants, by response category.
Outcome measures
| Measure |
Apple Watch and App
n=74 Participants
Participants receive standard care, and an Apple Watch to record activity through the NeuroCoach App.
|
Apple Watch and App
n=66 Participants
Participants receive standard care, and an Apple Watch to record activity through the NeuroCoach App.
|
|---|---|---|
|
Patient Satisfaction With Their Spine Care
Extremely satisfied
|
49 Participants
|
39 Participants
|
|
Patient Satisfaction With Their Spine Care
Very satisfied
|
17 Participants
|
19 Participants
|
|
Patient Satisfaction With Their Spine Care
Somewhat satisfied
|
4 Participants
|
4 Participants
|
|
Patient Satisfaction With Their Spine Care
Neutral
|
4 Participants
|
4 Participants
|
|
Patient Satisfaction With Their Spine Care
Not at all satisfied
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 months post-operativelyPopulation: Participants who completed the survey at this time point
Reported as the number of participants, by response category.
Outcome measures
| Measure |
Apple Watch and App
n=66 Participants
Participants receive standard care, and an Apple Watch to record activity through the NeuroCoach App.
|
Apple Watch and App
n=52 Participants
Participants receive standard care, and an Apple Watch to record activity through the NeuroCoach App.
|
|---|---|---|
|
Patient Satisfaction With Their Spine Care
Somewhat satisfied
|
5 Participants
|
2 Participants
|
|
Patient Satisfaction With Their Spine Care
Neutral
|
3 Participants
|
2 Participants
|
|
Patient Satisfaction With Their Spine Care
Not at all satisfied
|
0 Participants
|
2 Participants
|
|
Patient Satisfaction With Their Spine Care
Extremely satisfied
|
39 Participants
|
29 Participants
|
|
Patient Satisfaction With Their Spine Care
Very satisfied
|
19 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: 12 months post-operativelyPopulation: Participants who completed the survey at this time point
Reported as the number of participants, by response category.
Outcome measures
| Measure |
Apple Watch and App
n=82 Participants
Participants receive standard care, and an Apple Watch to record activity through the NeuroCoach App.
|
Apple Watch and App
n=68 Participants
Participants receive standard care, and an Apple Watch to record activity through the NeuroCoach App.
|
|---|---|---|
|
Patient Satisfaction With Their Spine Care
Extremely satisfied
|
52 Participants
|
33 Participants
|
|
Patient Satisfaction With Their Spine Care
Very satisfied
|
22 Participants
|
17 Participants
|
|
Patient Satisfaction With Their Spine Care
Somewhat satisfied
|
4 Participants
|
13 Participants
|
|
Patient Satisfaction With Their Spine Care
Neutral
|
1 Participants
|
1 Participants
|
|
Patient Satisfaction With Their Spine Care
Not at all satisfied
|
3 Participants
|
4 Participants
|
Adverse Events
Control
Apple Watch and App
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place