Adults 3 to 17, any sex, with Child, Preschool or Child. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed TasksPrimary· Up to 20 minutes on Day 1
Gait speed was the time taken to walk a specified distance. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walk
ActiGraph: Natural Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.83
± 0.192
Cohort A: Participants Aged 6-11 Years
1.00
± 0.142
Cohort A: Participants Aged 12-17 Years
1.04
± 0.174
GAITRite: Natural Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.93
± 0.234
Cohort A: Participants Aged 6-11 Years
1.13
± 0.127
Cohort A: Participants Aged 12-17 Years
1.21
± 0.177
APDM: Natural Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.81
± 0.213
Cohort A: Participants Aged 6-11 Years
1.02
± 0.119
Cohort A: Participants Aged 12-17 Years
1.10
± 0.171
ActiGraph: Fast Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
1.03
± 0.231
Cohort A: Participants Aged 6-11 Years
1.22
± 0.129
Cohort A: Participants Aged 12-17 Years
1.30
± 0.115
GAITRite: Fast Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
1.32
± 0.268
Cohort A: Participants Aged 6-11 Years
1.49
± 0.252
Cohort A: Participants Aged 12-17 Years
1.56
± 0.161
APDM: Fast Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
1.00
± 0.218
Cohort A: Participants Aged 6-11 Years
1.36
± 0.247
Cohort A: Participants Aged 12-17 Years
1.43
± 0.139
ActiGraph: Slow Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.56
± 0.150
Cohort A: Participants Aged 6-11 Years
0.58
± 0.173
Cohort A: Participants Aged 12-17 Years
0.64
± 0.173
GAITRite: Slow Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.57
± 0.164
Cohort A: Participants Aged 6-11 Years
0.54
± 0.151
Cohort A: Participants Aged 12-17 Years
0.75
± 0.204
Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed TasksPrimary· Up to 20 minutes on Day 1
Double support time referred to the phase during walking when both feet were in contact with the ground. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics d
ActiGraph: Natural Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.26
± 0.031
Cohort A: Participants Aged 6-11 Years
0.27
± 0.029
Cohort A: Participants Aged 12-17 Years
0.30
± 0.022
GAITRite: Natural Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.28
± 0.096
Cohort A: Participants Aged 6-11 Years
0.26
± 0.053
Cohort A: Participants Aged 12-17 Years
0.31
± 0.049
APDM: Natural Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.22
± 0.081
Cohort A: Participants Aged 6-11 Years
0.17
± 0.033
Cohort A: Participants Aged 12-17 Years
0.21
± 0.048
ActiGraph: Fast Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.23
± 0.020
Cohort A: Participants Aged 6-11 Years
0.24
± 0.028
Cohort A: Participants Aged 12-17 Years
0.27
± 0.020
GAITRite: Fast Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.18
± 0.048
Cohort A: Participants Aged 6-11 Years
0.20
± 0.057
Cohort A: Participants Aged 12-17 Years
0.24
± 0.042
APDM: Fast Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.16
± 0.027
Cohort A: Participants Aged 6-11 Years
0.13
± 0.031
Cohort A: Participants Aged 12-17 Years
0.14
± 0.039
ActiGraph: Slow Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.29
± 0.024
Cohort A: Participants Aged 6-11 Years
0.32
± 0.039
Cohort A: Participants Aged 12-17 Years
0.32
± 0.034
GAITRite: Slow Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.45
± 0.155
Cohort A: Participants Aged 6-11 Years
0.60
± 0.192
Cohort A: Participants Aged 12-17 Years
0.53
± 0.139
Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed TasksPrimary· Up to 20 minutes on Day 1
Single support time referred to the time when only one limb was in contact with the ground. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometery data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was dire
ActiGraph: Natural Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.36
± 0.054
Cohort A: Participants Aged 6-11 Years
0.38
± 0.050
Cohort A: Participants Aged 12-17 Years
0.42
± 0.028
GAITRite: Natural Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.36
± 0.034
Cohort A: Participants Aged 6-11 Years
0.37
± 0.037
Cohort A: Participants Aged 12-17 Years
0.40
± 0.027
APDM: Natural Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.39
± 0.045
Cohort A: Participants Aged 6-11 Years
0.42
± 0.042
Cohort A: Participants Aged 12-17 Years
0.46
± 0.022
ActiGraph: Fast Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.31
± 0.036
Cohort A: Participants Aged 6-11 Years
0.34
± 0.042
Cohort A: Participants Aged 12-17 Years
0.37
± 0.026
GAITRite: Fast Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.30
± 0.031
Cohort A: Participants Aged 6-11 Years
0.34
± 0.039
Cohort A: Participants Aged 12-17 Years
0.38
± 0.029
APDM: Fast Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.36
± 0.027
Cohort A: Participants Aged 6-11 Years
0.39
± 0.042
Cohort A: Participants Aged 12-17 Years
0.42
± 0.024
ActiGraph: Slow Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.47
± 0.080
Cohort A: Participants Aged 6-11 Years
0.59
± 0.140
Cohort A: Participants Aged 12-17 Years
0.58
± 0.123
GAITRite: Slow Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.43
± 0.058
Cohort A: Participants Aged 6-11 Years
0.51
± 0.074
Cohort A: Participants Aged 12-17 Years
0.48
± 0.045
Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed TasksPrimary· Up to 20 minutes on Day 1
Stance duration was defined as the duration of time the foot is in contact with the ground in a step during gait. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait
ActiGraph: Natural Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.63
± 0.085
Cohort A: Participants Aged 6-11 Years
0.65
± 0.072
Cohort A: Participants Aged 12-17 Years
0.72
± 0.054
GAITRite: Natural Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.64
± 0.129
Cohort A: Participants Aged 6-11 Years
0.64
± 0.082
Cohort A: Participants Aged 12-17 Years
0.72
± 0.062
APDM: Natural Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.60
± 0.119
Cohort A: Participants Aged 6-11 Years
0.59
± 0.070
Cohort A: Participants Aged 12-17 Years
0.66
± 0.065
ActiGraph: Fast Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.56
± 0.063
Cohort A: Participants Aged 6-11 Years
0.58
± 0.075
Cohort A: Participants Aged 12-17 Years
0.65
± 0.046
GAITRite: Fast Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.49
± 0.070
Cohort A: Participants Aged 6-11 Years
0.55
± 0.087
Cohort A: Participants Aged 12-17 Years
0.62
± 0.057
APDM: Fast Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.52
± 0.050
Cohort A: Participants Aged 6-11 Years
0.50
± 0.075
Cohort A: Participants Aged 12-17 Years
0.56
± 0.056
ActiGraph: Slow Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.75
± 0.081
Cohort A: Participants Aged 6-11 Years
0.91
± 0.127
Cohort A: Participants Aged 12-17 Years
0.83
± 0.166
GAITRite: Slow Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.88
± 0.207
Cohort A: Participants Aged 6-11 Years
1.11
± 0.265
Cohort A: Participants Aged 12-17 Years
1.02
± 0.178
Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed TasksPrimary· Up to 20 minutes on Day 1
Swing time was defined as the time during which the foot was not in contact with the ground. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was dire
Swing Duration Measured by Actigraph for Walk at Natural Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.36
± 0.054
Cohort A: Participants Aged 6-11 Years
0.38
± 0.050
Cohort A: Participants Aged 12-17 Years
0.42
± 0.028
Swing Duration Measured by GAITRite for Walk at Natural Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.35
± 0.034
Cohort A: Participants Aged 6-11 Years
0.37
± 0.037
Cohort A: Participants Aged 12-17 Years
0.40
± 0.027
Swing Duration Measured by APDM for Walk at Natural Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.39
± 0.047
Cohort A: Participants Aged 6-11 Years
0.42
± 0.041
Cohort A: Participants Aged 12-17 Years
0.45
± 0.021
Swing Duration Measured by Actigraph for Walk at Fast Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.31
± 0.030
Cohort A: Participants Aged 6-11 Years
0.33
± 0.043
Cohort A: Participants Aged 12-17 Years
0.37
± 0.027
Swing Duration Measured by GAITRite for Walk at Fast Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.30
± 0.029
Cohort A: Participants Aged 6-11 Years
0.34
± 0.039
Cohort A: Participants Aged 12-17 Years
0.38
± 0.028
Swing Duration Measured by APDM for Walk at Fast Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.35
± 0.025
Cohort A: Participants Aged 6-11 Years
0.39
± 0.042
Cohort A: Participants Aged 12-17 Years
0.42
± 0.025
Swing Duration Measured by Actigraph for Walk at Slow Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.45
± 0.067
Cohort A: Participants Aged 6-11 Years
0.53
± 0.096
Cohort A: Participants Aged 12-17 Years
0.56
± 0.106
Swing Duration Measured by GAITRite for Walk at Slow Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.43
± 0.058
Cohort A: Participants Aged 6-11 Years
0.50
± 0.074
Cohort A: Participants Aged 12-17 Years
0.48
± 0.045
Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed TasksPrimary· Up to 20 minutes of Day 1
Stride length was defined as the distance covered when two steps were taken, one with each foot. It was measured from the heel of one foot to the heel of same foot when it came into contact with the ground. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) wa
ActiGraph: Natural Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.80
± 0.112
Cohort A: Participants Aged 6-11 Years
1.01
± 0.139
Cohort A: Participants Aged 12-17 Years
1.16
± 0.146
GAITRite: Natural Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.89
± 0.113
Cohort A: Participants Aged 6-11 Years
1.13
± 0.127
Cohort A: Participants Aged 12-17 Years
1.35
± 0.116
APDM: Natural Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.78
± 0.126
Cohort A: Participants Aged 6-11 Years
1.02
± 0.114
Cohort A: Participants Aged 12-17 Years
1.22
± 0.118
ActiGraph: Fast Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.88
± 0.141
Cohort A: Participants Aged 6-11 Years
1.12
± 0.155
Cohort A: Participants Aged 12-17 Years
1.31
± 0.109
GAITRite: Fast Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
1.02
± 0.130
Cohort A: Participants Aged 6-11 Years
1.32
± 0.195
Cohort A: Participants Aged 12-17 Years
1.54
± 0.104
APDM: Fast Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.85
± 0.144
Cohort A: Participants Aged 6-11 Years
1.20
± 0.196
Cohort A: Participants Aged 12-17 Years
1.40
± 0.110
ActiGraph: Slow Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.67
± 0.122
Cohort A: Participants Aged 6-11 Years
0.75
± 0.104
Cohort A: Participants Aged 12-17 Years
0.90
± 0.142
GAITRite: Slow Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.71
± 0.116
Cohort A: Participants Aged 6-11 Years
0.82
± 0.136
Cohort A: Participants Aged 12-17 Years
1.08
± 0.155
Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed TasksPrimary· Up to 20 minutes on Day 1
Step duration was the period between the first contact of a foot and the first following contact of the contralateral foot. Participants had a single in-laboratory visit on Day 1 during which they performed gait monitoring procedures. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiG
ActiGraph: Natural Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.50
± 0.072
Cohort A: Participants Aged 6-11 Years
0.51
± 0.061
Cohort A: Participants Aged 12-17 Years
0.57
± 0.046
GAITRite: Natural Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.49
± 0.080
Cohort A: Participants Aged 6-11 Years
0.51
± 0.058
Cohort A: Participants Aged 12-17 Years
0.56
± 0.043
APDM: Natural Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.50
± 0.081
Cohort A: Participants Aged 6-11 Years
0.50
± 0.055
Cohort A: Participants Aged 12-17 Years
0.56
± 0.041
ActiGraph: Fast Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.44
± 0.061
Cohort A: Participants Aged 6-11 Years
0.45
± 0.059
Cohort A: Participants Aged 12-17 Years
0.51
± 0.037
GAITRite: Fast Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.39
± 0.048
Cohort A: Participants Aged 6-11 Years
0.44
± 0.058
Cohort A: Participants Aged 12-17 Years
0.50
± 0.037
APDM: Fast Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.43
± 0.035
Cohort A: Participants Aged 6-11 Years
0.44
± 0.058
Cohort A: Participants Aged 12-17 Years
0.50
± 0.038
ActiGraph: Slow Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.62
± 0.088
Cohort A: Participants Aged 6-11 Years
0.76
± 0.142
Cohort A: Participants Aged 12-17 Years
0.74
± 0.109
GAITRite: Slow Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.65
± 0.128
Cohort A: Participants Aged 6-11 Years
0.80
± 0.163
Cohort A: Participants Aged 12-17 Years
0.75
± 0.116
Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed TasksPrimary· Up to 20 minutes on Day 1
Cadence referred to the number of steps taken per minute during gait cycle. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted fr
ActiGraph: Natural Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
123.07
± 17.515
Cohort A: Participants Aged 6-11 Years
118.17
± 13.763
Cohort A: Participants Aged 12-17 Years
106.00
± 7.971
GAITRite: Natural Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
120.57
± 17.555
Cohort A: Participants Aged 6-11 Years
117.97
± 14.652
Cohort A: Participants Aged 12-17 Years
104.23
± 9.496
APDM: Natural Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
124.09
± 20.093
Cohort A: Participants Aged 6-11 Years
120.04
± 13.073
Cohort A: Participants Aged 12-17 Years
107.97
± 7.556
ActiGraph: Fast Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
139.59
± 17.740
Cohort A: Participants Aged 6-11 Years
134.16
± 17.301
Cohort A: Participants Aged 12-17 Years
118.24
± 8.667
GAITRite: Fast Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
147.26
± 19.313
Cohort A: Participants Aged 6-11 Years
130.42
± 16.612
Cohort A: Participants Aged 12-17 Years
113.16
± 9.725
APDM: Fast Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
139.50
± 10.993
Cohort A: Participants Aged 6-11 Years
137.06
± 17.574
Cohort A: Participants Aged 12-17 Years
122.30
± 9.326
ActiGraph: Slow Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
98.12
± 14.187
Cohort A: Participants Aged 6-11 Years
81.48
± 16.704
Cohort A: Participants Aged 12-17 Years
82.59
± 11.866
GAITRite: Slow Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
91.77
± 16.656
Cohort A: Participants Aged 6-11 Years
76.61
± 17.346
Cohort A: Participants Aged 12-17 Years
81.53
± 11.926
Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed TasksPrimary· Up to 20 minutes on Day 1
Stride duration refers to the duration between successive heel contacts of the same foot. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directl
ActiGraph: Natural Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.99
± 0.150
Cohort A: Participants Aged 6-11 Years
1.02
± 0.118
Cohort A: Participants Aged 12-17 Years
1.13
± 0.082
GAITRite: Natural Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.99
± 0.162
Cohort A: Participants Aged 6-11 Years
1.01
± 0.118
Cohort A: Participants Aged 12-17 Years
1.12
± 0.091
APDM: Natural Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.99
± 0.163
Cohort A: Participants Aged 6-11 Years
1.01
± 0.111
Cohort A: Participants Aged 12-17 Years
1.12
± 0.084
ActiGraph: Fast Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.88
± 0.132
Cohort A: Participants Aged 6-11 Years
0.91
± 0.115
Cohort A: Participants Aged 12-17 Years
1.01
± 0.073
GAITRite: Fast Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.78
± 0.093
Cohort A: Participants Aged 6-11 Years
0.89
± 0.123
Cohort A: Participants Aged 12-17 Years
0.99
± 0.079
APDM: Fast Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.87
± 0.070
Cohort A: Participants Aged 6-11 Years
0.89
± 0.113
Cohort A: Participants Aged 12-17 Years
0.99
± 0.076
ActiGraph: Slow Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
1.22
± 0.155
Cohort A: Participants Aged 6-11 Years
1.39
± 0.210
Cohort A: Participants Aged 12-17 Years
1.41
± 0.149
GAITRite: Slow Speed
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
1.30
± 0.258
Cohort A: Participants Aged 6-11 Years
1.61
± 0.327
Cohort A: Participants Aged 12-17 Years
1.49
± 0.226
Cohort A: Double Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated ActivitiesPrimary· Up to 20 minutes on Day 1
Double support time referred to the phase during walking when both feet were in contact with the ground. Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \[activity block 1\], approximately 5 minutes of break and approximately 7 minutes of activities \[activity block 2\]). Activities: 2
APDM: Activity Block 1
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.22
± 0.029
Cohort A: Participants Aged 6-11 Years
0.21
± 0.061
Cohort A: Participants Aged 12-17 Years
0.22
± 0.046
ActiGraph Lumbar: Activity Block 1
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.25
± 0.013
Cohort A: Participants Aged 6-11 Years
0.26
± 0.022
Cohort A: Participants Aged 12-17 Years
0.30
± 0.022
APDM: Activity Block 2
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.21
± 0.034
Cohort A: Participants Aged 6-11 Years
0.19
± 0.19
Cohort A: Participants Aged 12-17 Years
0.21
± 0.039
ActiGraph Lumbar: Activity Block 2
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.24
± 0.012
Cohort A: Participants Aged 6-11 Years
0.27
± 0.020
Cohort A: Participants Aged 12-17 Years
0.30
± 0.023
Cohort A: Single Limb Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated ActivitiesPrimary· Up to 20 minutes on Day 1
Single support time referred to the time when only one limb was in contact with the ground. Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \[activity block 1\], approximately 5 minutes of break and approximately 7 minutes of activities \[activity block 2\]). Activities: 2 sitting (e.g.
APDM: Activity Block 1
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.37
± 0.024
Cohort A: Participants Aged 6-11 Years
0.41
± 0.038
Cohort A: Participants Aged 12-17 Years
0.45
± 0.021
ActiGraph Lumbar: Activity Block 1
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.34
± 0.017
Cohort A: Participants Aged 6-11 Years
0.36
± 0.031
Cohort A: Participants Aged 12-17 Years
0.40
± 0.022
APDM: Activity Block 2
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.36
± 0.015
Cohort A: Participants Aged 6-11 Years
0.41
± 0.028
Cohort A: Participants Aged 12-17 Years
0.44
± 0.017
ActiGraph Lumbar: Activity Block 2
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.34
± 0.020
Cohort A: Participants Aged 6-11 Years
0.36
± 0.032
Cohort A: Participants Aged 12-17 Years
0.40
± 0.024
Cohort A: Stance Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated ActivitiesPrimary· Up to 20 minutes on Day 1
Stance duration was defined as the duration of time the foot is in contact with the ground in a step during gait. Participants had a single in-lab visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \[activity block 1\], approximately 5 minutes of break and approximately 7 minutes of activities \[activity block 2\]). Activities:
APDM: Activity Block 1
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.59
± 0.044
Cohort A: Participants Aged 6-11 Years
0.62
± 0.072
Cohort A: Participants Aged 12-17 Years
0.66
± 0.060
ActiGraph Lumbar: Activity Block 1
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.60
± 0.022
Cohort A: Participants Aged 6-11 Years
0.63
± 0.055
Cohort A: Participants Aged 12-17 Years
0.72
± 0.046
APDM: Activity Block 2
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.57
± 0.042
Cohort A: Participants Aged 6-11 Years
0.60
± 0.053
Cohort A: Participants Aged 12-17 Years
0.65
± 0.053
ActiGraph Lumbar: Activity Block 2
Group
Value
95% CI
Cohort A: Participants Aged 3-5 Years
0.60
± 0.029
Cohort A: Participants Aged 6-11 Years
0.63
± 0.051
Cohort A: Participants Aged 12-17 Years
0.71
± 0.041
Adverse events — posted to ClinicalTrials.gov
Time frame: From Day 1 to Day 15 (+3 days).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
COHORT A: To study whether a digital health tool called Actigraph can be used to collect information on gait and physical activity in healthy children aged 3-17. The study will be conducted at the Pfizer Innovation Research Laboratory (PfIRe Lab) in Cambridge MA. In the lab at the first visit, we will ask participants to do activities such as walking on different surfaces as well as to roll a dice and move between different activity stations. Children will wear 2 Actigraph devices, one as a watch and one as a belt. They will then go home and do usual daily activities while answering a brief daily activity diary for approximately 2 weeks. The conclusion of the study will be over the telephone and include questions on the comfort and wearability of the device. The analysis of gait and physical activity as well as adherence and wearability will be looked across three different age groups 3-5, 6-11, and 12-17.
COHORT B: Cohort B of the study aims to evaluate the feasibility of the Panoramic Bracelet and associated algorithms such as SleepPy and GaitPy compared to the GENEActiv device and to evaluate the comfort and wearability of the Panoramic Bracelet. The results of this study will enable the use of novel devices in future clinical trials measuring scratch and sleep. . In the lab at the first visit, we will ask participants to do activities such as walking on different surfaces as well as to roll a dice and move between different activity stations. They will then go home and do usual daily activities while wearing both devices in the same wrist at different times stipulated in the protocol, answering a brief daily activity and sleep diary for approximately 2 weeks. Cohort B includes questions on the comfort and wearability of the Panoramic device on Day 7 approximately. The conclusion of the study will be over the telephone.The analysis will be looked across three different age groups 3-5, 6-11, and 12-17
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 11 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04823650.