Evaluating an Extension Assist Knee Ankle Foot Orthosis to Improve Gait in Children With Movement Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Peak knee angle
研究概览
简要总结
Background:
- Cerebral palsy (CP) is the most common motor disorder in children. CP often causes crouch gait, an abnormal way of walking. Knee crouch has many causes, so no single device or approach works best for everybody. This study s adjustable brace provides many types of walking assistance. Researchers will evaluate brace options to find the best solution for each participant, and whether one solution works best for the group.
Objective:
- To evaluate a new brace to improve crouch gait in children with CP.
Eligibility:
- Children 5 17 years old with CP.
- Healthy volunteers 5 17 years old.
Design:
- All participants will be screened with medical history and physical exam.
- Healthy volunteers will have 1 visit. They will do motion analysis, EMG, and EEG described below.
- Participants with CP will have 6 visits.
- Visit 1:
<TAB>1. Motion analysis: Balls will be taped to participants skin. This helps cameras follow their movement.
<TAB>2. EMG: Metal discs will be taped to participants skin. They measure electrical muscle activity.
<TAB>3. Participants knee movement will be tested.
<TAB>4. Participants will walk 50 meters.
<TAB>5. Participants legs will be cast to make custom braces.
- Visit 2:
- Participants will wear their new braces and have them adjusted.
- Steps 1 3 will be repeated.
- EEG: Small metal discs will be placed on the participants scalp. They record brain waves.
- Participants will have electrical stimulation of their knees and practice extending them.
- Participants will take several walks with the braces in different settings.
- Visits 3 5: participants will repeat the walking and some other steps from visit 2.
- Visit 6 will repeat visit 2.
详细描述
Objective
The purpose of this protocol is to evaluate several configurations of a prototype Extension Assist Knee-Ankle-Foot Orthosis (EA-KAFO) in patients with cerebral palsy (CP), muscular dystrophy (MD), spina bifida (SB), or incomplete spinal cord injury (iSCI) who have knee extension deficiency. Three forms of assistance will be provided at the knee joint including a passive-damper component, functional electrical stimulation (FES) to the quadriceps, and a motorized assist. One form will provide controllable resistance at the knee to strengthen muscles and promote knee extension after the resistance is removed. These will be compared to traditional bracing which typically improves crouch by blocking some or all motion at one or both joints. We hypothesize that all assistive configurations will improve gait alignment and performance compared to the non-assisted conditions. We further hypothesize that a best solution for each participant will exist, but may vary across subjects due to the heterogeneity of these movement disorders. Preliminary data on brain activation using EEG will be collected during all walking conditions.
Study population
Thirty (30) subjects, age 5 and above, diagnosed with crouch gait from diplegic CP, (30) subjects, age 5 and above, with knee extension deficiency from MD, SB, or iSCI (15 from each group) and 10 age-matched healthy volunteers will be recruited.
Design
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •Age 5 years and above
- •Either a healthy volunteer, have crouch gait with a diagnosis of spastic diplegic cerebral palsy, or have lower extremity weakness resulting in gait pathology from a diagnosis of muscular dystrophy, spina bifida, or incomplete spinal cord injury.
- •Able to understand and follow simple directions based on parent report and physician observation during history and physical examination.
- •Able to provide verbal/written assent.
- •Less than 5 degrees of knee flexion contracture with hip extended in supine position. Hamstring contracture as assessed by straight leg raising test does not limit ability to participate in the study.
- •Less than 10 degrees of plantar flexion contracture in neutral foot alignment.
- •A measured foot-thigh angle of -10 to 25 degrees in prone position.
- •Diagnosed with knee extension deficiency as indicated by a crouched posture during gait lacking at least 20 degrees of knee extension at mid stance during walking as assessed visually, knee extensor muscle weakness which prevents full extension of the limb, or reliance upon braces or other aids which lock the knee during walking. (The exact level of knee extension deficiency, or crouch, will be quantified after inclusion using gait analysis.)
- •Able to walk at least 10 feet without stopping with or without a walking aid
- •Agreement to not drink caffeine for 24 hours before each EEG assessment (CP only) visit because it can modify brain activity
排除标准
- •Any neurological, musculoskeletal or cardiorespiratory injury, health condition, or diagnosis other than cerebral palsy, muscular dystrophy, spina bifida, or incomplete spinal cord injury that would affect the ability to walk as directed for short periods of time.
- •Participation in this protocol within the previous 1 year.
- •ADDITIONAL EXCLUSION CRITERIA FOR INDIVIDUALS WITH CEREBRAL PALSY:
- •A history of a seizure in the past year.
- •Pregnancy
研究组 & 干预措施
There is a single study arm in this feasibility study.
All participants will be evaluated using the different configurations of the EA-KAFO (see Table 1 in the protocol), which includes the configuration that contains the Active Motorized KAFO and the configuration that contains the Powerwalk Knee Exoskeleton. Each subject will serve as their own control to assess the effect of each configuration of the EA-KAFO interventions.
干预措施: EA-KAFO (Device)
结局指标
主要结局
Peak knee angle
时间窗: This outcome will be assessed twice, at the initial and final data assessment visits, as indicated in the protocol.
The primary outcome measure will be the effect of the intervention on crouch, as measured by peak knee angle during walking with the EA-KAFO. the outcome description refers to the general Extension Assist Knee Ankle Foot Orthosis (EA-KAFO). The outcome measure will be assessed across the different configurations of the EA-KAFO, which includes the configuration that contains the Active Motorized KAFO and the configuration that contains the Powerwalk Knee Exoskeleton.
次要结局
- Secondary outcome measures(At the same time)