Accidental Falls, Arthritis, Cancer, Diabetes, End Stage Renal Failure on Dialysis, Fall Due to Loss of Equilibrium, High Risk of Falls Due to Mobility Limitation, Parkinson's Disease, Peripheral Arterial Disease
Conditions
Keywords
Ankle Foot Orthoses, falls, Fall Prevention, Frailty, Concern for falls, Footwear, Mobility
Brief summary
The investigators propose a randomized control trial to evaluate long term effects and effectiveness of Moore Balance Brace (MBB) ankle foot orthoses (AFO) in reducing risk of falling in older adults. Primary Endpoints • Characterize the impact of MBB AFO on balance, gait, risk of falling, frailty status, and adverse events Secondary Endpoints • Characterize the Impact of MBB AFO on spontaneous daily physical activities • Characterize the feasibility of the MBB AFO device on patient adherence, acceptability, user-friendliness, and perception of benefit for daily usage
Interventions
OTHERControl
Subjects will be provided with a pair of New Balance 813 shoes
DEVICEMBB AFO
Subjects will be provided with a pair of New Balance 813 shoes plus a custom made MBB AFO
Sponsors
Orthotic Holdings, Inc.
Bijan Najafi, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 65 or older * High concerns or high risk of fall * Ambulatory
Exclusion criteria
* Presence of an active wound infection on either of the foot and ankle * Use of medication or a medical condition that may have unstable (fluctuate over time) or temporary (less than one month) impact on gait and balance * Acute fractures on the foot * Participant of an interventional study within the last 30 days * Non-ambulatory or unable to stand without help or walk a distance of at least 1.8 m (\ six feet) without assistance * Major foot amputation * Unable or unwilling to participate in all procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hip Sway Change From Baseline to 6 Months | 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) |
| Ankle Sway Change From Baseline to 6 Months | 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) |
| Center of Mass (COM) Sway Change Baseline to 6 Months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity Level | baseline to 6 months | 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). |
| Number of Participants With Adverse Events | assessed at 1, 3, 6, and 12 months, month 12 reported | 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. |
| Percentage of Participants Who Found the Device Useful and Easy to Use | 6 months | 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. |
| Adherence (Hours Per Day to Wear Ankle-Foot Orthosis (AFO)) | 6 months | 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?). |
| Stride Time | baseline, 6 months | stride time measured in single task walking with normal speed |
| Stride Length | baseline, 6 months | stride length measured in single-task walking with normal speed |
| Stride Velocity | baseline, 6 months | stride velocity measured in single-task walking with normal speed |
| Fall Incidents | Baseline, 12 months | Fall incidents during the study |
| Concern for Falling Change Form Baseline to 6 Months | Baseline, 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 22 |
| 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 | 22 |
| Total | 44 |
Baseline characteristics
| Characteristic | Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Total |
|---|---|---|---|
| Age, Continuous | 73.7 years STANDARD_DEVIATION 6.3 | 75.6 years STANDARD_DEVIATION 6.5 | 74.7 years STANDARD_DEVIATION 6.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 20 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 22 participants | 22 participants | 44 participants |
| Sex: Female, Male Female | 17 Participants | 14 Participants | 31 Participants |
| Sex: Female, Male Male | 5 Participants | 8 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
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)
Time frame: baseline to 6 months
Population: Some participants in AFO and No AFO groups withdrew from study in 6 months. Mixed Model Analysis can handle such missing data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Ankle Sway Change From Baseline to 6 Months | @6Month | 1.03 degree^2 | Standard Deviation 0.69 |
| Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Ankle Sway Change From Baseline to 6 Months | Baseline | 3.50 degree^2 | Standard Deviation 3.74 |
| No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Ankle Sway Change From Baseline to 6 Months | Baseline | 3.21 degree^2 | Standard Deviation 2.43 |
| No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Ankle Sway Change From Baseline to 6 Months | @6Month | 3.56 degree^2 | Standard Deviation 2.54 |
Comparison: Repeated measures to compare the changes in both groups from baseline to 6 monthsp-value: 0.005Mixed Models Analysis
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)
Time frame: baseline to 6 months
Population: Some participants in AFO and No AFO groups withdrew from study in 6 months. Mixed Model Analysis can handle such missing data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Center of Mass (COM) Sway Change Baseline to 6 Months | Baseline | 0.71 cm^2 | Standard Deviation 0.5 |
| Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Center of Mass (COM) Sway Change Baseline to 6 Months | @6Month | 0.32 cm^2 | Standard Deviation 0.18 |
| No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Center of Mass (COM) Sway Change Baseline to 6 Months | Baseline | 0.85 cm^2 | Standard Deviation 0.65 |
| No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Center of Mass (COM) Sway Change Baseline to 6 Months | @6Month | 0.76 cm^2 | Standard Deviation 0.54 |
Comparison: Repeated measures to compare the changes in both groups from baseline to 6 monthsp-value: 0.019Mixed Models Analysis
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)
Time frame: baseline to 6 months
Population: Some participants in AFO and No AFO groups withdrew from study in 6 months. Mixed Model Analysis can handle such missing data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Hip Sway Change From Baseline to 6 Months | Baseline | 3.65 degree^2 | Standard Deviation 3.22 |
| Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Hip Sway Change From Baseline to 6 Months | @6Month | 2.15 degree^2 | Standard Deviation 1.24 |
| No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Hip Sway Change From Baseline to 6 Months | Baseline | 3.75 degree^2 | Standard Deviation 3.63 |
| No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Hip Sway Change From Baseline to 6 Months | @6Month | 3.89 degree^2 | Standard Deviation 2.15 |
Comparison: Repeated measures to compare changes in two groups from baseline to 6 monthsp-value: 0.04Mixed Models Analysis
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?).
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Adherence (Hours Per Day to Wear Ankle-Foot Orthosis (AFO)) | 5.4 hours per day | Standard Deviation 3.3 |
| No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Adherence (Hours Per Day to Wear Ankle-Foot Orthosis (AFO)) | 5.6 hours per day | Standard Deviation 3.2 |
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.
Time frame: Baseline, 6 months
Population: Some participants in AFO and No AFO groups withdrew from study in 6 months. Mixed Model Analysis can handle such missing data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Concern for Falling Change Form Baseline to 6 Months | Baseline | 32.8 score on a scale | Standard Deviation 10.7 |
| Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Concern for Falling Change Form Baseline to 6 Months | @6Month | 27.0 score on a scale | Standard Deviation 9 |
| No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Concern for Falling Change Form Baseline to 6 Months | Baseline | 33.3 score on a scale | Standard Deviation 11.5 |
| No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Concern for Falling Change Form Baseline to 6 Months | @6Month | 30.1 score on a scale | Standard Deviation 13.9 |
Comparison: Repeated measures to compare the changes between groups from baseline to 6 monthsp-value: 0.65Mixed Models Analysis
Secondary
Fall Incidents
Fall incidents during the study
Time frame: Baseline, 12 months
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Fall Incidents | Baseline | 2.27 falls per year precedent | Standard Deviation 4.17 |
| Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Fall Incidents | @12Month | 0.80 falls per year precedent | Standard Deviation 1.27 |
| No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Fall Incidents | Baseline | 1.82 falls per year precedent | Standard Deviation 4.19 |
| No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Fall Incidents | @12Month | 0.94 falls per year precedent | Standard Deviation 1.25 |
Comparison: Repeated measures to compare the changes of both groups from pre-intervention to post-intervention year.p-value: 0.572Generalized Estimating Equations
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.
Time frame: assessed at 1, 3, 6, and 12 months, month 12 reported
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Number of Participants With Adverse Events | 0 Participants |
| No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Number of Participants With Adverse Events | 0 Participants |
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.
Time frame: 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Percentage of Participants Who Found the Device Useful and Easy to Use | perceived usefulness | 79 percentage of participants |
| Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Percentage of Participants Who Found the Device Useful and Easy to Use | perceived ease of use | 93 percentage of participants |
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).
Time frame: baseline to 6 months
Population: Some participants in AFO and No AFO groups withdrew from study in 6 months. Mixed Model Analysis can handle such missing data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Physical Activity Level | Baseline | 4017 number of steps per day | Standard Deviation 2008 |
| Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Physical Activity Level | @6Month | 4872 number of steps per day | Standard Deviation 2657 |
| No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Physical Activity Level | Baseline | 3847 number of steps per day | Standard Deviation 3645 |
| No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Physical Activity Level | @6Month | 4297 number of steps per day | Standard Deviation 2735 |
Comparison: Repeated measures to compare the changes between groups from baseline to 6 monthsp-value: 0.756Mixed Models Analysis
Secondary
Stride Length
stride length measured in single-task walking with normal speed
Time frame: baseline, 6 months
Population: Some participants in AFO and No AFO groups withdrew from study in 6 months. Mixed Model Analysis can handle such missing data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Stride Length | Baseline | 0.98 meters | Standard Deviation 0.17 |
| Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Stride Length | 6 months | 1.05 meters | Standard Deviation 0.22 |
| No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Stride Length | Baseline | 0.96 meters | Standard Deviation 0.22 |
| No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Stride Length | 6 months | 1.01 meters | Standard Deviation 0.27 |
Comparison: Repeated measures to compare the changes between groups from baseline to 6 monthsp-value: 0.829Mixed Models Analysis
Secondary
Stride Time
stride time measured in single task walking with normal speed
Time frame: baseline, 6 months
Population: Some participants in AFO and No AFO groups withdrew from study in 6 months. Mixed Model Analysis can handle such missing data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Stride Time | Baseline | 1.27 seconds | Standard Deviation 0.18 |
| Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Stride Time | 6 months | 1.25 seconds | Standard Deviation 0.23 |
| No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Stride Time | Baseline | 1.24 seconds | Standard Deviation 0.21 |
| No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Stride Time | 6 months | 1.21 seconds | Standard Deviation 0.18 |
Comparison: Repeated measures to compare the changes between groups from baseline to 6 monthsp-value: 0.857Mixed Models Analysis
Secondary
Stride Velocity
stride velocity measured in single-task walking with normal speed
Time frame: baseline, 6 months
Population: Some participants in AFO and No AFO groups withdrew from study in 6 months. Mixed Model Analysis can handle such missing data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Stride Velocity | Baseline | 0.80 m/sec | Standard Deviation 0.23 |
| Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Stride Velocity | 6 months | 0.88 m/sec | Standard Deviation 0.27 |
| No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Stride Velocity | Baseline | 0.81 m/sec | Standard Deviation 0.27 |
| No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group | Stride Velocity | 6 months | 0.88 m/sec | Standard Deviation 0.3 |
Comparison: Repeated measures to compare the changes between groups from baseline to 6 monthsp-value: 0.769Mixed Models Analysis