N/A
Completed N=87
Monitoring Activity And Gait In Children
Child, Preschool · Child · Adolescent
Source: ClinicalTrials.gov NCT04823650 ↗
Enrolled (actual)
87
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcomePrimary: Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks — 0.83; 1.00; 1.04; 0.93 Meters per second
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks |
0.83; 1.00; 1.04; 0.93; 1.13; 1.21 | — |
| PRIMARY Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks |
0.26; 0.27; 0.30; 0.28; 0.26; 0.31 | — |
| PRIMARY Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks |
0.36; 0.38; 0.42; 0.36; 0.37; 0.40 | — |
| PRIMARY Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks |
0.63; 0.65; 0.72; 0.64; 0.64; 0.72 | — |
| PRIMARY Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks |
0.36; 0.38; 0.42; 0.35; 0.37; 0.40 | — |
| PRIMARY Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks |
0.80; 1.01; 1.16; 0.89; 1.13; 1.35 | — |
| PRIMARY Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks |
0.50; 0.51; 0.57; 0.49; 0.51; 0.56 | — |
| PRIMARY Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks |
123.07; 118.17; 106.00; 120.57; 117.97; 104.23 | — |
| PRIMARY Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks |
0.99; 1.02; 1.13; 0.99; 1.01; 1.12 | — |
| PRIMARY Cohort A: Double Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities |
0.22; 0.21; 0.22; 0.25; 0.26; 0.30 | — |
| PRIMARY Cohort A: Single Limb Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities |
0.37; 0.41; 0.45; 0.34; 0.36; 0.40 | — |
| PRIMARY Cohort A: Stance Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities |
0.59; 0.62; 0.66; 0.60; 0.63; 0.72 | — |
| PRIMARY Cohort A: Swing Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities |
0.36; 0.40; 0.44; 0.33; 0.36; 0.40 | — |
| PRIMARY Cohort A: Stride Length Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities |
0.73; 0.89; 1.12; 0.86; 0.99; 1.05 | — |
| PRIMARY Cohort A: Step Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities |
0.46; 0.50; 0.55; 0.47; 0.49; 0.56 | — |
| PRIMARY Cohort A: Cadence Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities |
126.97; 118.54; 109.47; 128.71; 122.32; 108.15 | — |
| PRIMARY Cohort A: Gait Speed Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities |
0.72; 0.80; 0.97; 0.91; 0.98; 0.95 | — |
| PRIMARY Cohort A: Total Number of Steps Measured by APDM, ActiGraph Lumbar and ActiGraph Wrist for In-lab Simulated Activities |
109.23; 123.00; 154.62; 103.00; 163.43; 114.46 | — |
| PRIMARY Cohort A: Stride Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities |
0.95; 1.02; 1.10; 0.94; 0.99; 1.10 | — |
| PRIMARY Cohort B: Total Sleep Time During the At-Home Period |
561.21; 520.34; 459.92; 567.48; 524.57; 450.53 | — |
| PRIMARY Cohort B: Percentage of Time Asleep During the At-Home Period |
95.65; 94.93; 94.85; 94.85; 94.94; 94.08 | — |
| PRIMARY Cohort B: Number of Wake Bouts During the At-Home Period |
8.74; 9.59; 9.40; 9.69; 9.57; 9.37 | — |
| PRIMARY Cohort B: Sleep Onset Latency During the At-Home Period |
2.64; 3.82; 2.39; 3.69; 4.01; 3.64 | — |
| PRIMARY Cohort B: Wake After Sleep Onset During the At-Home Period |
22.38; 24.36; 21.62; 26.44; 23.58; 22.01 | — |
| PRIMARY Cohort B: Total Scratch Duration During the At-Home Period |
2.45; 3.29; 3.35; 3.17; 3.19; 3.75 | — |
| PRIMARY Cohort B: Total Scratch Episodes During the At-Home Period |
34.74; 45.60; 46.04; 43.81; 43.45; 49.74 | — |
| PRIMARY Cohort B: Number of Available Minutes During the At-Home Period |
1389.08; 1386.44; 1385.76; 1234.49; 1260.18; 1310.20 | — |
| PRIMARY Cohort B: Number of Minutes of Wear During the At-Home Period |
1095.45; 1099.07; 1044.66; 727.98; 785.81; 789.37 | — |
| PRIMARY Cohort B: Number of Wear Minutes While Awake During the At-Home Period |
813.15; 883.23; 845.01; 706.48; 768.64; 775.16 | — |
| PRIMARY Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7 |
0; 0; 0; 1; 1; 0 | — |
| PRIMARY Cohort A: Number of Days to Complete Enrollment |
232; 101; 77 | — |
| SECONDARY Cohort A: Number of Participants Enrolled Over Time |
5; 3; 5; 2; 6; 5 | — |
| SECONDARY Cohort A: Number of Participants Able to Perform Each of the 7 Lab-Based Tasks |
13; 14; 13; 13; 14; 13 | — |
| SECONDARY Cohort A: Percentage of Tasks Completed (From a Total of 7 Tasks) |
100; 100; 100 | — |
| SECONDARY Cohort A: Number of Hours Per Day Wearing the Lumbar and Wrist Devices |
21.05; 21.80; 22.01; 7.24; 12.51; 14.24 | — |
| SECONDARY Cohort A: Number of Days With More Than 10 Hours of Wear Time for Lumbar Device |
6.15; 11.71; 11.69 | — |
| SECONDARY Cohort A: Number of Days With More Than 18 Hours of Wear Time for Wrist Device |
12.38; 13.21; 12.54 | — |
| SECONDARY Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1 |
1; 0; 0; 0; 0; 1 | — |
| SECONDARY Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation |
1; 0; 0; 2; 0; 2 | — |
| SECONDARY Cohort A: Double Support Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis |
0.28; 0.20; 0.28; 0.19 | — |
| SECONDARY Cohort A: Single Limb Support Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis |
0.39; 0.42; 0.38; 0.42 | — |
| SECONDARY Cohort A: Stance Time Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis |
0.67; 0.62; 0.66; 0.61 | — |
| SECONDARY Cohort A: Swing Time Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis |
0.39; 0.42; 0.38; 0.42 | — |
| SECONDARY Cohort A: Stride Length Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis |
1.00; 1.01; 1.00; 1.01 | — |
| SECONDARY Cohort A: Step Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis |
0.53; 0.52; 0.52; 0.51 | — |
| SECONDARY Cohort A: Cadence Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis |
115.08; 116.79; 117.56; 119.62 | — |
| SECONDARY Cohort A: Gait Speed Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis |
0.95; 0.97; 0.97; 1.00 | — |
| SECONDARY Cohort A: Stride Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis |
1.05; 1.04; 1.04; 1.02 | — |
| SECONDARY Cohort B: Number of Hours Per Day Wearing the Panoramic Bracelet Devices at Home |
22.65; 22.80; 22.60 | — |
| SECONDARY Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks |
0.29; 0.32; 0.34; 0.20; 0.25; 0.31 | — |
| SECONDARY Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks |
0.31; 0.34; 0.39; 0.31; 0.37; 0.39 | — |
| SECONDARY Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks |
0.61; 0.66; 0.73; 0.52; 0.63; 0.71 | — |
| SECONDARY Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks |
0.30; 0.34; 0.38; 0.32; 0.37; 0.39 | — |
| SECONDARY Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks |
1.01; 1.24; 1.29; 0.88; 1.20; 1.37 | — |
| SECONDARY Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks |
0.46; 0.50; 0.55; 0.42; 0.49; 0.55 | — |
| SECONDARY Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks |
138.45; 119.94; 108.89; 144.80; 122.16; 109.98 | — |
| SECONDARY Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task |
1.15; 1.24; 1.17; 1.07; 1.21; 1.25 | — |
| SECONDARY Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks |
0.90; 1.00; 1.11; 0.84; 0.99; 1.10 | — |
Eligibility Criteria
Inclusion Criteria
- Ambulatory
- No significant health problems that would impair the completion of the physical activity tasks, does not carry any diagnosis of developmental delay and/or significant co-morbid medical conditions as determined by a medically qualified individual during medical history review
Exclusion Criteria
- Participation in other studies involving digital devices within 1 week and/or treatment with an investigational drug (Phases 1-4) within 30 days or 5 half-lives before the current study begins and/or during study participation.
- Participants with implanted medical devices.
- Minor participants who reach the age of majority during the study, as recognized under local law.
- Any medical or psychiatric condition that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Participants with known allergies to components as specified by device manufacturer if applicable (eg, plastic, stainless steel and silicone).
Data sourced from ClinicalTrials.gov (NCT04823650). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.