Single Case Experimental Design (SCED) Comparing an Off-the-shelf Carbon Ankle Foot Orthosis (SPRYSTEP) Versus an off-the Shelf Standard Plastic Ankle Foot Orthosis in the Treatment of Walking Functional Impairment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Thuasne
- 入组人数
- 20
- 试验地点
- 8
- 主要终点
- Comparison of the ability to achieve personal goals while wearing carbon or standard plastic ankle foot orthosis
研究概览
简要总结
The objective of this study is to assess the superiority in achieving personal goals (set by the patient and the medical team) according to the GAS scale (Goal Attainment Scaling) while wearing the carbon medical device Ankle Foot Orthosis (AFO) compared to a standard plastic ankle foot orthosis.
详细描述
Foot drop is a symptom observed in various pathologies including neuro-muscular pathologies of peripheral or central origin. It is a walking disability, causing a deterioration in the patients autonomy and quality of life.
The current medical strategy focuses on various off-the-shelf or custom made devices, depending on the walking functional impairment and the characteristics of foot deformities.
The objective of this study is to assess the superiority in achieving personal goals (set by the patient and the medical team) according to the GAS scale (Goal Attainment Scaling) while wearing the carbon medical device ankle foot orthosis compared to a standard plastic ankle foot orthosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with a foot levator muscles impairment (single or bilateral drop foot) and / or instability of the back of the foot, associated with a deficit of the triceps
- •Patient with inability to stand on tip-toe on one foot
- •Patient having signed a free and informed consent
- •Patient affiliated or entitled to a social security scheme
排除标准
- •Patient with fixed varus-equine foot
- •Patient with an unstable skin condition (whether or not treated with additional treatment that may change the footwear)
- •Patient with a a foot levator muscles impairment with a deficiency of the quadriceps and hamstrings (knee involvement)
- •Patient with uncontrolled spasticity
- •Patient for whom foot surgery is planned during the study
- •Patient with one of the contraindications to the use of carbon medical device, indicated in the instructions for use
- •Patient with one of the contraindications to the use of the standard plastic ankle foot orthosis, indicated in the instructions for use
- •Patient with orthopedic comorbidities affecting the musculoskeletal system
- •Pregnant woman
- •Patient with major cognitive impairment incompatible with participation in a clinical trial
- •Patient participating in another clinical investigation conducted to establish the compliance of a MD impacting the evaluation criteria
- •Patient who cannot be followed for 12 weeks
- •Vulnerable patient according to article L1121-6 of the public health code, persons subject to a measure of judicial protection or unable to consent freely
结局指标
主要结局
Comparison of the ability to achieve personal goals while wearing carbon or standard plastic ankle foot orthosis
时间窗: 3 times a week during 12 weeks
Personal goals achievement is evaluated via the Goal attainment scaling (GAS). Before starting the study, three personal objectives are defined according to patients needs and investigator review. Raw scores ranging from -3 (degradation) to +2 (maximum achievement of the objective) are defined: "-3" corresponding to degradation "-2" corresponding to the initial state "-1" corresponding to a partial objective achievement "0" corresponding to the total objective achievement "+1" corresponding to a better objective achievement "+2" corresponding to the maximum objective achievement. The GAS is filled 3 times a week during 12 weeks.
次要结局
- Comparison of patients fatigue while wearing carbon or standard plastic ankle foot orthosis(Visits V0 (Day 0), V1 (between week 2 and 3), V2 (between week 5 and 6), V3 (between week 8 and 9) and V4 (Week 12))
- Comparison of patients stability while wearing carbon or standard plastic ankle foot orthosis(Visits V0 (Day 0), V1 (between week 2 and 3), V2 (between week 5 and 6), V3 (between week 8 and 9) and V4 (Week 12))
- Comparison of patients walking perimeter while wearing carbon or standard plastic ankle foot orthosis(Visits V0 (Day 0), V1 (between week 2 and 3), V2 (between week 5 and 6), V3 (between week 8 and 9) and V4 (Week 12))
- Comparison of patients disability evolution according to the investigator while wearing carbon or standard plastic ankle foot orthosis(Visits V0 (Day 0), V1 (between week 2 and 3), V2 (between week 5 and 6), V3 (between week 8 and 9) and V4 (Week 12))
- Comparison of patients disability evolution according to the patient while wearing carbon or standard plastic ankle foot orthosis(Visits V0 (Day 0), V1 (between week 2 and 3), V2 (between week 5 and 6), V3 (between week 8 and 9) and V4 (Week 12))
- Comparison of pain, gait and balance evolution according to the patient while wearing carbon or standard plastic ankle foot orthosis(Visits V0 (Day 0), V1 (between week 2 and 3), V2 (between week 5 and 6), V3 (between week 8 and 9) and V4 (Week 12))
- Comparison of tolerance of carbon and standard plastic ankle foot orthosis(Visits V0 (Day 0), V1 (between week 2 and 3), V2 (between week 5 and 6), V3 (between week 8 and 9) and V4 (Week 12))
- Patients satisfaction with carbon and standard plastic ankle foot orthosis(V4 at 12 weeks)
- Comparison of patients mobility while wearing carbon or standard plastic ankle foot orthosis(Visits V0 (Day 0), V1 (between week 2 and 3), V2 (between week 5 and 6), V3 (between week 8 and 9) and V4 (Week 12).)
- Comparison of acceptability and compliance with carbon and standard plastic ankle foot orthosis(Visits V0 (Day 0), V1 (between week 2 and 3), V2 (between week 5 and 6), V3 (between week 8 and 9) and V4 (Week 12))