Evaluation of the NEUROSWING Orthosis on Walking Speed in a Population With Dorsal and/or Plantar Flexor Deficits, With a View to a Reimbursement Application. Clinical Investigation: NS-BOOSST
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 34
- 试验地点
- 4
- 主要终点
- Walking speed : 10m walk test
研究概览
简要总结
The aim of this randomized, cross-over, multi-center, intention-to-treat, open-label study study is to determine the benefits of the NEUROSWING device on gait speed in patients with dorsal and/or plantar flexor deficits, compared with the use of a carbon orthosis. Each patient will benefit in random order from a 14-day investigation period with the NEUROSWING device and a 14-day control period with a carbon orthosis. These two 2-week periods will be separated by one week, during which no orthosis will be worn and no evaluation will be carried out. Patients will be randomized to determine which phase they will start with. The primary endpoint is walking speed, which will be measured by comparing the results of the 10-meter walk test. For the secondary endpoints, patients will be assessed using the Functional Gait Assessment (FGA), the 6-minute test and an analysis system that will analyze other gait parameters (duration of the different phases of the gait cycle, cadence and step length). In order to carry out the assessments, each patient included will have 12 visits spread over 5 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 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
- •18 years of age and older
- •Deficit of the dorsal and/or plantar flexors with at least one of the following components specific to the indication of an AFO:
- •foot drop,
- •spasticity,
- •failure to transfer weight-bearing,
- •instability of weight-bearing phase
- •compensatory hyperextension of the knee
- •Muscular deficiency of the dorsal and/or plantar flexors principal or accessory
- •Ambulation possible with or without technical aids
- •First time using an orthosis used in the study
- •Being followed in one of the investigating centers whose management and rehabilitation in line with the study's visit schedule.
- •Having freely consented to participate
- •Affiliated with a social security scheme
排除标准
- •Cognitive disorders, at the investigator's discretion, impacting the reliability of the clinical tests under study.
- •Pathology in progressive phase at the time of inclusion that could significantly impact walking (e.g. MS, ALS, etc.) during the entire study period.
- •Medically unstable (e.g. severe cardiovascular disorders) as judged by the investigating physician.
- •Behavioral disorders (opposition, agitation, dementia) which, according to the investigator's judgment, would have an impact on walking.
- •Already fitted with a carbon or NEUROSWING orthosis.
- •Height over 214cm
- •Weight over 193kg
- •Pregnant, parturient or breast-feeding women
- •Person deprived of liberty by a court order (including guardianship, curatorship and safeguard of justice) or administrative order
- •Person under psychiatric care or admitted to a health or social establishment for purposes other than research
- •Person in an emergency situation unable to give consent beforehand
结局指标
主要结局
Walking speed : 10m walk test
时间窗: At all 12 visits from baseline (day 1), to end of study (day 35)
次要结局
- Functional Gait Assessment (FGA)(At baseline (day 1), day 14, day 22 and end of study (day 35))
- 6 minute walk test(At baseline (day 1), day 14, day 22 and end of study (day 35))
- Spatio-temoral gait analysis(At baseline (day 1), day 14, day 22 and end of study (day 35))