| Primary | Hip Sway Change From Baseline to 6 Months | Hip sway (motion of hip joints in three dimensions) measured by wearable sensors while wearing their own shoes compared to the orthopedic shoes and compared to orthopedic shoes plus Ankle-Foot Orthosis (AFO) | Some participants in AFO and No AFO groups withdrew from study in 6 months. Mixed Model Analysis can handle such missing data | Posted | | Mean | Standard Deviation | degree^2 | | baseline to 6 months | | | | ID | Title | Description |
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| OG000 | Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | This group will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) for the duration of the study. Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO): Subjects will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) | | OG001 | No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | This group will be provided with a pair of New Balance 813 shoes for the duration of the study. Control: Subjects will be provided with a pair of New Balance 813 shoes |
| | | Title | Denominators | Categories |
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| Baseline | - ParticipantsOG00022
- ParticipantsOG00122
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Repeated measures to compare changes in two groups from baseline to 6 months | Mixed Models Analysis | | 0.040 | priori threshold for statistical significance= 0.05 | | | | | | | | | | | | | Superiority | | |
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| Primary | Ankle Sway Change From Baseline to 6 Months | Ankle sway (motion of ankle joint in three dimensions) measured by wearable inertial sensors while wearing their own shoes compared to the orthopedic shoes and compared to orthopedic shoes plus Ankle-Foot Orthosis (AFO) | Some participants in AFO and No AFO groups withdrew from study in 6 months. Mixed Model Analysis can handle such missing data | Posted | | Mean | Standard Deviation | degree^2 | | baseline to 6 months | | | | ID | Title | Description |
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| OG000 | Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | This group will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) for the duration of the study. Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO): Subjects will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) | | OG001 | No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | This group will be provided with a pair of New Balance 813 shoes for the duration of the study. Control: Subjects will be provided with a pair of New Balance 813 shoes |
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| Primary | Center of Mass (COM) Sway Change Baseline to 6 Months | Center of Mass (COM) sway measured by wearable inertial sensors while wearing their own shoes compared to the orthopedic shoes and compared to orthopedic shoes plus Ankle-Foot Orthosis (AFO) | Some participants in AFO and No AFO groups withdrew from study in 6 months. Mixed Model Analysis can handle such missing data | Posted | | Mean | Standard Deviation | cm^2 | | baseline to 6 months | | | | ID | Title | Description |
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| OG000 | Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | This group will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) for the duration of the study. Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO): Subjects will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) | | OG001 | No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | This group will be provided with a pair of New Balance 813 shoes for the duration of the study. Control: Subjects will be provided with a pair of New Balance 813 shoes |
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| Secondary | Adherence (Hours Per Day to Wear Ankle-Foot Orthosis (AFO)) | The adherence of participants to the prescribed Ankle-Foot Orthosis (AFO) plus walking shoes was quantified using the response to a self-reported question ("How many hours per day did you wear the prescribed footwear?"). | | Posted | | Mean | Standard Deviation | hours per day | | 6 months | | | | ID | Title | Description |
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| OG000 | Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | This group will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) for the duration of the study. Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO): Subjects will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) | | OG001 | No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | This group will be provided with a pair of New Balance 813 shoes for the duration of the study. Control: Subjects will be provided with a pair of New Balance 813 shoes |
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| Secondary | Fall Incidents | Fall incidents during the study | Some participants in AFO and No AFO groups withdrew from study in 6 and 12 months. Generalized Estimating Equation Analysis can handle such missing data | Posted | | Mean | Standard Deviation | falls per year precedent | | Baseline, 12 months | | | | ID | Title | Description |
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| OG000 | Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | This group will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) for the duration of the study. Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO): Subjects will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) | | OG001 | No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | This group will be provided with a pair of New Balance 813 shoes for the duration of the study. Control: Subjects will be provided with a pair of New Balance 813 shoes |
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| Secondary | Concern for Falling Change Form Baseline to 6 Months | Concern for falling is quantified by Falls Efficacy Scale - International (FES-I) questionnaire. Scores range from minimum 16 (no concern about falling) to maximum 64 (severe concern about falling). Higher score indicate worse performance. | Some participants in AFO and No AFO groups withdrew from study in 6 months. Mixed Model Analysis can handle such missing data | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, 6 months | | | | ID | Title | Description |
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| OG000 | Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | This group will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) for the duration of the study. Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) : Subjects will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) | | OG001 | No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | This group will be provided with a pair of New Balance 813 shoes for the duration of the study. Control: Subjects will be provided with a pair of New Balance 813 shoes |
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| Secondary | Physical Activity Level | Physical activity level for 24 hours while wearing their own shoes compared to the walking shoes and compared to walking shoes plus Ankle-Foot Orthosis (AFO). To quantify physical activity, number of taken steps per day was monitored using a pendant wearable sensor called, PAMSys (Biosensics, MA, USA). | Some participants in AFO and No AFO groups withdrew from study in 6 months. Mixed Model Analysis can handle such missing data | Posted | | Mean | Standard Deviation | number of steps per day | | baseline to 6 months | | | | ID | Title | Description |
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| OG000 | Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | This group will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) for the duration of the study. Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO): Subjects will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) | | OG001 | No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | This group will be provided with a pair of New Balance 813 shoes for the duration of the study. Control: Subjects will be provided with a pair of New Balance 813 shoes |
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| Secondary | Number of Participants With Adverse Events | Number of participants with adverse events reported during the study. Adverse events was inquired at 1 months, 3 months, 6 months, 12 months after the baseline, and summed at 12 months. If the participant has at least one adverse event reported in any assessed time frame, the participant will be categorized as the participant with adverse event. | | Posted | | Count of Participants | | Participants | | assessed at 1, 3, 6, and 12 months, month 12 reported | | | | ID | Title | Description |
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| OG000 | Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | This group will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) for the duration of the study. Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO): Subjects will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) | | OG001 | No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | This group will be provided with a pair of New Balance 813 shoes for the duration of the study. Control: Subjects will be provided with a pair of New Balance 813 shoes |
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| Secondary | Percentage of Participants Who Found the Device Useful and Easy to Use | The participants perceived usefulness of ease of use of wearing Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) based on questionnaires of A technology acceptance model (TAM). Perceived usefulness was assessed using two questions (i.e., "I feel more stable when standing," and "I feel more stable when walking"). Perceived ease of use was assessed using two questions (i.e., "Was easy to take on and off," and "Was comfortable to wear"). The Likert scale (6-point scale from 0-5) was used to quantify how much they disagreed with each statement, including "strongly disagree," "disagree," "somewhat disagree," "somewhat agree," "agree," and "strongly agree," respectively. In this paper, responses were only categorized as positive (3-5 points) or negative (0-2 points) attitudes towards the use of AFO plus walking shoes. | | Posted | | Number | | percentage of participants | | 6 months | | | | ID | Title | Description |
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| OG000 | Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | This group will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) for the duration of the study. Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO): Subjects will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) |
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| Secondary | Stride Velocity | stride velocity measured in single-task walking with normal speed | Some participants in AFO and No AFO groups withdrew from study in 6 months. Mixed Model Analysis can handle such missing data | Posted | | Mean | Standard Deviation | m/sec | | baseline, 6 months | | | | ID | Title | Description |
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| OG000 | Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | This group will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) for the duration of the study. Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO): Subjects will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) | | OG001 | No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | This group will be provided with a pair of New Balance 813 shoes for the duration of the study. Control: Subjects will be provided with a pair of New Balance 813 shoes |
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| Secondary | Stride Time | stride time measured in single task walking with normal speed | Some participants in AFO and No AFO groups withdrew from study in 6 months. Mixed Model Analysis can handle such missing data | Posted | | Mean | Standard Deviation | seconds | | baseline, 6 months | | | | ID | Title | Description |
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| OG000 | Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | This group will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) for the duration of the study. Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO): Subjects will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) | | OG001 | No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | This group will be provided with a pair of New Balance 813 shoes for the duration of the study. Control: Subjects will be provided with a pair of New Balance 813 shoes |
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| Secondary | Stride Length | stride length measured in single-task walking with normal speed | Some participants in AFO and No AFO groups withdrew from study in 6 months. Mixed Model Analysis can handle such missing data | Posted | | Mean | Standard Deviation | meters | | baseline, 6 months | | | | ID | Title | Description |
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| OG000 | Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | This group will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) for the duration of the study. Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO): Subjects will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) | | OG001 | No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | This group will be provided with a pair of New Balance 813 shoes for the duration of the study. Control: Subjects will be provided with a pair of New Balance 813 shoes |
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