OHI--Randomized Control Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Custom AFO
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Hip Sway Change From Baseline to 6 Months
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65 or older
- •High concerns or high risk of fall
- •Ambulatory
排除标准
- •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
研究组 & 干预措施
MBB AFO Group
This group will be provided with a pair of New Balance 813 shoes plus a custom made MBB AFO for the duration of the study.
干预措施: MBB AFO (Device)
No MBB AFO Group
This group will be provided with a pair of New Balance 813 shoes for the duration of the study.
干预措施: Control (Other)
结局指标
主要结局
Hip Sway Change From Baseline to 6 Months
时间窗: 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
时间窗: 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
时间窗: 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)
次要结局
- Adherence (Hours Per Day to Wear Ankle-Foot Orthosis (AFO))(6 months)
- Fall Incidents(Baseline, 12 months)
- Concern for Falling Change Form Baseline to 6 Months(Baseline, 6 months)
- Physical Activity Level(baseline to 6 months)
- Number of Participants With Adverse Events(assessed at 1, 3, 6, and 12 months, month 12 reported)
- Stride Velocity(baseline, 6 months)
- Stride Time(baseline, 6 months)
- Percentage of Participants Who Found the Device Useful and Easy to Use(6 months)
- Stride Length(baseline, 6 months)
研究者
Bijan Najafi, PhD
Professor of Surgery
Baylor College of Medicine