Mobility and Quality of Life in Community Ambulators With Knee Locking Deficiency Using a Microprocessor Controlled Knee Ankle Foot Orthosis and a Stance Control Orthosis: Randomized Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 18
- 主要终点
- PLUS-M™ - Mobility
研究概览
简要总结
The purpose of this multicentric study is to assess the impact of C-BRACE on mobility, endurance, confidence, participation, satisfaction, psychosocial adjustment and quality of life in community ambulators using a Stance Control Orthosis.
详细描述
During two months of inclusion period, the investigators invite all patients matching with inclusion criteria for an enrolment visit, collect written consent and record general patient information. The eCRF (electronic Case Report Form) assigns the enrolled patient into one group for the trial (C-BRACE/SCO or SCO/C-BRACE), in a randomized order. The assessments are performed after 2 month follow-up period with each orthosis with a minimal wash-out period of 2 weeks.
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
- 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
- •person with knee locking deficiency
- •person using a SCO (Stance Control Orthosis) for at least three months, walking with a swing phase on a flat ground, without walking aid or with one cane or one crutch.
- •person having the ability to walk at 3km/h (measured with 10 meters walk test) with the SCO in unlocked mode.
- •person with a stable stance phase on the contralateral side
排除标准
- •person with deficient or unstable contralateral knee, including person using a Knee-Ankle Foot Orthosis on the contralateral limb
- •person walking using two canes, two crutches, one or two underarm crutches or a walker
- •person with health condition not compatible with the study protocol
- •person under 18 years old
- •person unwilling / unable to follow the entire study protocol / instructions
- •person who did not give her written consent to participate to the study or unable to personally give her consent
- •person with knee and/or hip flexion contracture >10°
- •person with genu varum / valgum > 10° (not reducible)
- •person with moderate to severe spasticity
- •person with leg length discrepancy > 15cm
- •person who necessitate the use of an orthoprosthesis
- •person with body weight > 125kg
- •person with unstable trunk in standing position
- •person with cognitive impairments
结局指标
主要结局
PLUS-M™ - Mobility
时间窗: 2-months
12-items Self-reported measure of mobility as the ability to move intentionally and independently from one place to another.
次要结局
- ABC-s Activities-specific Balance Confidence - simplified(2-months)
- 6 minutes walk test(2-months)
- PSFS - Patient Specific Functional Scale(2-months)
- PIADS - Psychosocial Impact of Assistive Devices Scale(2-months)
- EQ-5D-5L - Quality of Life(2-months)
- QUEST 2.0 - Satisfaction(2-months)