The Effects of AFO Heel Height and Stiffness on Gait
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Modified Socket Comfort Score (Comfort)
研究概览
简要总结
The proposed study evaluates the effect of ankle foot orthosis (AFO) heel height and stiffness on the forces and motion of the lower limb during over-ground walking in individuals who use an AFO for daily walking. Previous studies suggest that heel height and stiffness effect limb loading, but these data and the analysis techniques applied are limited. In this study, heel cushions with different height and stiffness's (4 conditions) will be placed in participants shoes and they will walk at controlled and self-selected speeds. Participants will also walk with their AFO as configured prior to enrollment, and with no AFO if possible. The proposed study will provide evidence that can be used by clinicians and researchers to align braces that most effectively improve function during every-day walking.
详细描述
In this study the investigators to evaluate the effect of ankle foot orthosis (AFO) heel height and stiffness on the forces and motion of the lower limb during over-ground walking in individuals who use an AFO for daily walking. Previous studies suggest that heel height and stiffness effect limb loading, but these data and the analysis techniques applied are limited.
Two groups of subjects with impairments below the knee, that result in functional deficits and require daily AFO use, will be recruited for this study. The first group will have unilateral deficits associated with musculoskeletal injury or disease (Group 1), and the second group will have bilateral or unilateral deficits associated with peripheral nervous system disease (Group 2).
Lower limb forces and body motion will be assessed using computerized motion capture and force plates in the floor, as individuals walk over-ground. Small reflective markers placed on the participant's skin and force measuring plates in the floor will be used. Participants will walk with their clinically provided AFO, with added heel cushions of two different heights and stiffness's (4 conditions) at a controlled velocity and self-selected velocity. If able, they will walk without their AFO at a self-selected pace. Participants will be asked to provide information regarding their health condition and opinions of the conditions tested.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Participants will be blinded to the heel wedge conditions.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GROUP 1 Patient Inclusion criteria
- •Ages: 18-70
- •Daily AFO use to address unilateral, below knee functional deficits that result from limb injury or musculoskeletal disease (e.g. fracture, muscle and/or nerve injury, ankle arthritis)
- •Greater than 2 weeks using their current AFO
- •Ability to walk 50 feet without use of an assistive device (Cane, crutch, etc.)
- •Ability to walk at a slow to moderate pace
- •AFO fits into traditional footwear
- •Able to read and write in English and provide written informed consent
- •GROUP 1 Patient
排除标准
- •Pain > 6/10 while walking during testing or an increase in pain during testing of > 2/
- •Central Nervous System disorder or disease (e.g. Stroke, Cerebral Palsy, Spinal Cord Injury, or other conditions that result in lower limb spasticity).
- •Disorder or disease that affects peripheral nerve function (e.g. diabetes, Charcot Marie Tooth).
- •Limited contralateral lower limb function due to injury or neurological/musculoskeletal disorder.
- •Use of a hinged/articulating AFO (e.g. Plantar flexion stop, Dorsiflexion assist/stop, free motion), Charcot Restraint Orthotic Walker (CROW) boot, AFOs that restrict all motion in the ankle and foot.
- •Use of an AFO that crosses the knee (Knee brace)
- •Insufficient space in shoe to accommodate the tallest heel wedge and their AFO
- •Visual or hearing impairments that limit walking ability or could limit the ability to comply with instructions given during testing
- •Pregnancy - Per participant self-report. Due the expected small number of pregnant individuals, and resulting inability to account for its effect on resulting outcomes participants will be withdrawn from the study.
- •Body Mass index >
- •GROUP 2 Patient Inclusion Criteria
- •Ages: 18-70
- •Daily AFO use to address below knee functional deficits that result from disease involving the peripheral nervous system (e.g. Charcot Marie Tooth, Multiple Sclerosis, diabetes)
- •Greater than 2 weeks using their current AFO (unilateral or bilateral)
- •Ability to walk 50 feet without use of an assistive device (Cane, crutch, etc.)
- •AFO fits into traditional footwear
- •Ability to walk at a slow to moderate pace
- •Able to read and write in English and provide written informed consent
- •GROUP 2 Patient Exclusion Criteria
- •Pain > 6/10 while walking or an increase in pain during testing of > 2/10
- •Central Nervous System disorder or disease (e.g. Stroke, Cerebral Palsy, Spinal Cord Injury, or other conditions that result in lower limb spasticity)
- •Limited function due to limb injury (e.g. fracture, muscle and/or nerve injury)
- •Use of a hinged/articulating AFO (e.g. Plantar flexion stop, Dorsiflexion assist/stop, free motion), Charcot Restraint Orthotic Walker (CROW) boot, AFOs that restrict all motion in the ankle and foot.
- •Use of an AFO that crosses the knee (Knee brace)
- •Insufficient space in shoe to accommodate the tallest heel wedge and their AFO
- •Visual or hearing impairment that limit walking ability or limit the ability to comply with instructions given during testing
- •Pregnancy - Per participant self-report. Due the expected small number of pregnant individuals, and resulting inability to account for its effect on resulting outcomes participants will be withdrawn from the study
- •Body Mass index > 40.
研究组 & 干预措施
Arm 1:
Testing Order: Clinical AFO, Tall Soft, Tall Firm, Short Soft, Short Firm, NoAFO
干预措施: Short Soft (Device)
Arm 1:
Testing Order: Clinical AFO, Tall Soft, Tall Firm, Short Soft, Short Firm, NoAFO
干预措施: Tall Soft (Device)
Arm 1:
Testing Order: Clinical AFO, Tall Soft, Tall Firm, Short Soft, Short Firm, NoAFO
干预措施: Tall Firm (Device)
Arm 1:
Testing Order: Clinical AFO, Tall Soft, Tall Firm, Short Soft, Short Firm, NoAFO
干预措施: Short Firm (Device)
Arm 2:
Testing Order: Clinical AFO, Tall Soft, Tall Firm, Short Firm, Short Soft, NoAFO
干预措施: Tall Soft (Device)
Arm 2:
Testing Order: Clinical AFO, Tall Soft, Tall Firm, Short Firm, Short Soft, NoAFO
干预措施: Tall Firm (Device)
Arm 3:
Testing Order: Clinical AFO, Tall Soft, Short Soft, Tall Firm, Short Firm, NoAFO
干预措施: Tall Firm (Device)
Arm 3:
Testing Order: Clinical AFO, Tall Soft, Short Soft, Tall Firm, Short Firm, NoAFO
干预措施: Short Soft (Device)
Arm 3:
Testing Order: Clinical AFO, Tall Soft, Short Soft, Tall Firm, Short Firm, NoAFO
干预措施: Short Firm (Device)
Arm 4:
Testing Order: Clinical AFO, Tall Soft, Short Soft, Short Firm, Tall Firm, NoAFO
干预措施: Tall Soft (Device)
Arm 2:
Testing Order: Clinical AFO, Tall Soft, Tall Firm, Short Firm, Short Soft, NoAFO
干预措施: Short Soft (Device)
Arm 2:
Testing Order: Clinical AFO, Tall Soft, Tall Firm, Short Firm, Short Soft, NoAFO
干预措施: Short Firm (Device)
Arm 3:
Testing Order: Clinical AFO, Tall Soft, Short Soft, Tall Firm, Short Firm, NoAFO
干预措施: Tall Soft (Device)
Arm 4:
Testing Order: Clinical AFO, Tall Soft, Short Soft, Short Firm, Tall Firm, NoAFO
干预措施: Tall Firm (Device)
Arm 4:
Testing Order: Clinical AFO, Tall Soft, Short Soft, Short Firm, Tall Firm, NoAFO
干预措施: Short Soft (Device)
Arm 4:
Testing Order: Clinical AFO, Tall Soft, Short Soft, Short Firm, Tall Firm, NoAFO
干预措施: Short Firm (Device)
Arm 5:
Testing Order: Clinical AFO, Tall Soft, Short Firm, Tall Firm, Short Soft, NoAFO
干预措施: Tall Soft (Device)
Arm 5:
Testing Order: Clinical AFO, Tall Soft, Short Firm, Tall Firm, Short Soft, NoAFO
干预措施: Tall Firm (Device)
Arm 5:
Testing Order: Clinical AFO, Tall Soft, Short Firm, Tall Firm, Short Soft, NoAFO
干预措施: Short Soft (Device)
Arm 5:
Testing Order: Clinical AFO, Tall Soft, Short Firm, Tall Firm, Short Soft, NoAFO
干预措施: Short Firm (Device)
Arm 6:
Testing Order: Clinical AFO, Tall Soft, Short Firm, Short Soft, Tall Firm, NoAFO
干预措施: Tall Soft (Device)
Arm 6:
Testing Order: Clinical AFO, Tall Soft, Short Firm, Short Soft, Tall Firm, NoAFO
干预措施: Tall Firm (Device)
Arm 6:
Testing Order: Clinical AFO, Tall Soft, Short Firm, Short Soft, Tall Firm, NoAFO
干预措施: Short Soft (Device)
Arm 6:
Testing Order: Clinical AFO, Tall Soft, Short Firm, Short Soft, Tall Firm, NoAFO
干预措施: Short Firm (Device)
Arm 7:
Testing Order: Clinical AFO, Tall Firm, Tall Soft, Short Soft, Short Firm, NoAFO
干预措施: Tall Soft (Device)
Arm 7:
Testing Order: Clinical AFO, Tall Firm, Tall Soft, Short Soft, Short Firm, NoAFO
干预措施: Tall Firm (Device)
Arm 7:
Testing Order: Clinical AFO, Tall Firm, Tall Soft, Short Soft, Short Firm, NoAFO
干预措施: Short Soft (Device)
Arm 7:
Testing Order: Clinical AFO, Tall Firm, Tall Soft, Short Soft, Short Firm, NoAFO
干预措施: Short Firm (Device)
Arm 8:
Testing Order: Clinical AFO, Tall Firm, Tall Soft, Short Firm, Short Soft, NoAFO
干预措施: Tall Soft (Device)
Arm 8:
Testing Order: Clinical AFO, Tall Firm, Tall Soft, Short Firm, Short Soft, NoAFO
干预措施: Tall Firm (Device)
Arm 8:
Testing Order: Clinical AFO, Tall Firm, Tall Soft, Short Firm, Short Soft, NoAFO
干预措施: Short Soft (Device)
Arm 8:
Testing Order: Clinical AFO, Tall Firm, Tall Soft, Short Firm, Short Soft, NoAFO
干预措施: Short Firm (Device)
Arm 9:
Testing Order: Clinical AFO, Tall Firm, Short Soft, Tall Soft, Short Firm, NoAFO
干预措施: Tall Soft (Device)
Arm 9:
Testing Order: Clinical AFO, Tall Firm, Short Soft, Tall Soft, Short Firm, NoAFO
干预措施: Tall Firm (Device)
Arm 9:
Testing Order: Clinical AFO, Tall Firm, Short Soft, Tall Soft, Short Firm, NoAFO
干预措施: Short Soft (Device)
Arm 9:
Testing Order: Clinical AFO, Tall Firm, Short Soft, Tall Soft, Short Firm, NoAFO
干预措施: Short Firm (Device)
Arm 10:
Testing Order: Clinical AFO, Tall Firm, Short Soft, Short Firm, Tall Soft, NoAFO
干预措施: Tall Soft (Device)
Arm 10:
Testing Order: Clinical AFO, Tall Firm, Short Soft, Short Firm, Tall Soft, NoAFO
干预措施: Tall Firm (Device)
Arm 10:
Testing Order: Clinical AFO, Tall Firm, Short Soft, Short Firm, Tall Soft, NoAFO
干预措施: Short Soft (Device)
Arm 10:
Testing Order: Clinical AFO, Tall Firm, Short Soft, Short Firm, Tall Soft, NoAFO
干预措施: Short Firm (Device)
Arm 11:
Testing Order: Clinical AFO, Tall Firm, Short Firm, Tall Soft, Short Soft, NoAFO
干预措施: Tall Soft (Device)
Arm 11:
Testing Order: Clinical AFO, Tall Firm, Short Firm, Tall Soft, Short Soft, NoAFO
干预措施: Tall Firm (Device)
Arm 11:
Testing Order: Clinical AFO, Tall Firm, Short Firm, Tall Soft, Short Soft, NoAFO
干预措施: Short Soft (Device)
Arm 11:
Testing Order: Clinical AFO, Tall Firm, Short Firm, Tall Soft, Short Soft, NoAFO
干预措施: Short Firm (Device)
Arm 12:
Testing Order: Clinical AFO, Tall Firm, Short Firm, Short Soft, Tall Soft, NoAFO
干预措施: Tall Soft (Device)
Arm 12:
Testing Order: Clinical AFO, Tall Firm, Short Firm, Short Soft, Tall Soft, NoAFO
干预措施: Tall Firm (Device)
Arm 12:
Testing Order: Clinical AFO, Tall Firm, Short Firm, Short Soft, Tall Soft, NoAFO
干预措施: Short Soft (Device)
Arm 12:
Testing Order: Clinical AFO, Tall Firm, Short Firm, Short Soft, Tall Soft, NoAFO
干预措施: Short Firm (Device)
Arm 13:
Testing Order: Clinical AFO, Short Soft, Tall Soft, Short Firm, Tall Firm, NoAFO
干预措施: Tall Soft (Device)
Arm 13:
Testing Order: Clinical AFO, Short Soft, Tall Soft, Short Firm, Tall Firm, NoAFO
干预措施: Tall Firm (Device)
Arm 13:
Testing Order: Clinical AFO, Short Soft, Tall Soft, Short Firm, Tall Firm, NoAFO
干预措施: Short Soft (Device)
Arm 13:
Testing Order: Clinical AFO, Short Soft, Tall Soft, Short Firm, Tall Firm, NoAFO
干预措施: Short Firm (Device)
Arm 14:
Testing Order: Clinical AFO, Short Soft, Tall Soft, Tall Firm, Short Firm, NoAFO
干预措施: Tall Soft (Device)
Arm 14:
Testing Order: Clinical AFO, Short Soft, Tall Soft, Tall Firm, Short Firm, NoAFO
干预措施: Tall Firm (Device)
Arm 14:
Testing Order: Clinical AFO, Short Soft, Tall Soft, Tall Firm, Short Firm, NoAFO
干预措施: Short Soft (Device)
Arm 14:
Testing Order: Clinical AFO, Short Soft, Tall Soft, Tall Firm, Short Firm, NoAFO
干预措施: Short Firm (Device)
Arm 15:
Testing Order: Clinical AFO, Short Soft, Tall Firm, Short Firm, Tall Soft, NoAFO
干预措施: Tall Soft (Device)
Arm 15:
Testing Order: Clinical AFO, Short Soft, Tall Firm, Short Firm, Tall Soft, NoAFO
干预措施: Tall Firm (Device)
Arm 15:
Testing Order: Clinical AFO, Short Soft, Tall Firm, Short Firm, Tall Soft, NoAFO
干预措施: Short Soft (Device)
Arm 15:
Testing Order: Clinical AFO, Short Soft, Tall Firm, Short Firm, Tall Soft, NoAFO
干预措施: Short Firm (Device)
Arm 16:
Testing Order: Clinical AFO, Short Soft, Tall Firm, Tall Soft, Short Firm, NoAFO
干预措施: Tall Soft (Device)
Arm 16:
Testing Order: Clinical AFO, Short Soft, Tall Firm, Tall Soft, Short Firm, NoAFO
干预措施: Tall Firm (Device)
Arm 16:
Testing Order: Clinical AFO, Short Soft, Tall Firm, Tall Soft, Short Firm, NoAFO
干预措施: Short Soft (Device)
Arm 16:
Testing Order: Clinical AFO, Short Soft, Tall Firm, Tall Soft, Short Firm, NoAFO
干预措施: Short Firm (Device)
Arm 17:
Testing Order: Clinical AFO, Short Soft, Short Firm, Tall Soft, Tall Firm, NoAFO
干预措施: Tall Soft (Device)
Arm 17:
Testing Order: Clinical AFO, Short Soft, Short Firm, Tall Soft, Tall Firm, NoAFO
干预措施: Tall Firm (Device)
Arm 17:
Testing Order: Clinical AFO, Short Soft, Short Firm, Tall Soft, Tall Firm, NoAFO
干预措施: Short Soft (Device)
Arm 17:
Testing Order: Clinical AFO, Short Soft, Short Firm, Tall Soft, Tall Firm, NoAFO
干预措施: Short Firm (Device)
Arm 18:
Testing Order: Clinical AFO, Short Soft, Short Firm, Tall Firm, Tall Soft, NoAFO
干预措施: Tall Soft (Device)
Arm 18:
Testing Order: Clinical AFO, Short Soft, Short Firm, Tall Firm, Tall Soft, NoAFO
干预措施: Tall Firm (Device)
Arm 21:
Testing Order: Clinical AFO, Short Firm, Tall Firm, Short Soft, Tall Soft, NoAFO
干预措施: Tall Firm (Device)
Arm 18:
Testing Order: Clinical AFO, Short Soft, Short Firm, Tall Firm, Tall Soft, NoAFO
干预措施: Short Soft (Device)
Arm 18:
Testing Order: Clinical AFO, Short Soft, Short Firm, Tall Firm, Tall Soft, NoAFO
干预措施: Short Firm (Device)
Arm 19:
Testing Order: Clinical AFO, Short Firm, Tall Soft, Tall Firm, Short Soft, NoAFO
干预措施: Tall Soft (Device)
Arm 19:
Testing Order: Clinical AFO, Short Firm, Tall Soft, Tall Firm, Short Soft, NoAFO
干预措施: Tall Firm (Device)
Arm 19:
Testing Order: Clinical AFO, Short Firm, Tall Soft, Tall Firm, Short Soft, NoAFO
干预措施: Short Soft (Device)
Arm 19:
Testing Order: Clinical AFO, Short Firm, Tall Soft, Tall Firm, Short Soft, NoAFO
干预措施: Short Firm (Device)
Arm 20:
Testing Order: Clinical AFO, Short Firm, Tall Soft, Short Soft, Tall Firm, NoAFO
干预措施: Tall Soft (Device)
Arm 20:
Testing Order: Clinical AFO, Short Firm, Tall Soft, Short Soft, Tall Firm, NoAFO
干预措施: Tall Firm (Device)
Arm 20:
Testing Order: Clinical AFO, Short Firm, Tall Soft, Short Soft, Tall Firm, NoAFO
干预措施: Short Soft (Device)
Arm 20:
Testing Order: Clinical AFO, Short Firm, Tall Soft, Short Soft, Tall Firm, NoAFO
干预措施: Short Firm (Device)
Arm 21:
Testing Order: Clinical AFO, Short Firm, Tall Firm, Short Soft, Tall Soft, NoAFO
干预措施: Tall Soft (Device)
Arm 21:
Testing Order: Clinical AFO, Short Firm, Tall Firm, Short Soft, Tall Soft, NoAFO
干预措施: Short Soft (Device)
Arm 21:
Testing Order: Clinical AFO, Short Firm, Tall Firm, Short Soft, Tall Soft, NoAFO
干预措施: Short Firm (Device)
Arm 22:
Testing Order: Clinical AFO, Short Firm, Tall Firm, Tall Soft, Short Soft, NoAFO
干预措施: Tall Soft (Device)
Arm 22:
Testing Order: Clinical AFO, Short Firm, Tall Firm, Tall Soft, Short Soft, NoAFO
干预措施: Tall Firm (Device)
Arm 22:
Testing Order: Clinical AFO, Short Firm, Tall Firm, Tall Soft, Short Soft, NoAFO
干预措施: Short Soft (Device)
Arm 22:
Testing Order: Clinical AFO, Short Firm, Tall Firm, Tall Soft, Short Soft, NoAFO
干预措施: Short Firm (Device)
Arm 23:
Testing Order: Clinical AFO, Short Firm, Short Soft, Tall Firm, Tall Soft, NoAFO
干预措施: Tall Soft (Device)
Arm 23:
Testing Order: Clinical AFO, Short Firm, Short Soft, Tall Firm, Tall Soft, NoAFO
干预措施: Tall Firm (Device)
Arm 23:
Testing Order: Clinical AFO, Short Firm, Short Soft, Tall Firm, Tall Soft, NoAFO
干预措施: Short Soft (Device)
Arm 23:
Testing Order: Clinical AFO, Short Firm, Short Soft, Tall Firm, Tall Soft, NoAFO
干预措施: Short Firm (Device)
Arm 24:
Testing Order: Clinical AFO, Short Firm, Short Soft, Tall Soft, Tall Firm, NoAFO
干预措施: Tall Soft (Device)
Arm 24:
Testing Order: Clinical AFO, Short Firm, Short Soft, Tall Soft, Tall Firm, NoAFO
干预措施: Tall Firm (Device)
Arm 24:
Testing Order: Clinical AFO, Short Firm, Short Soft, Tall Soft, Tall Firm, NoAFO
干预措施: Short Soft (Device)
Arm 24:
Testing Order: Clinical AFO, Short Firm, Short Soft, Tall Soft, Tall Firm, NoAFO
干预措施: Short Firm (Device)
结局指标
主要结局
Modified Socket Comfort Score (Comfort)
时间窗: Baseline
Comfort scores range from 0 = most uncomfortable to 10 = most comfortable.
Center of pressure velocity timing
时间窗: Baseline
Timing of peak center of pressure velocity (percent stance) during gait.
Numerical Pain Rating Scale
时间窗: Baseline
Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable.
Center of pressure velocity magnitude
时间窗: Baseline
Magnitude of peak center of pressure velocity (m/s) during gait.
Modified Socket Comfort Score (Smoothness)
时间窗: Baseline
Smoothness scores range from 0 = least smooth to 10 = most smooth.
Participant wedge preference
时间窗: Baseline
The participant will rank order their preference for their Clinical AFO, Tall Soft, Tall Firm, Short Soft, or Short Firm wedge on a questionnaire.
次要结局
- Peak Ankle Power(Baseline)
- Ankle Range of Motion(Baseline)
- Peak Ankle Moment(Baseline)
研究者
Jason Wilken
Associate Professor
University of Iowa