Research Report: CERITER Clinical Study - Stride One
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Complete and correct foot roll-off
研究概览
简要总结
The goal of this clinical study is to investigate the short-term impact of the use of Ceriter Stride One on the quality of gait in patients rehabilitating after a cerebrovascular accident (CVA). Stride One is a smart insole that provides real-time audio feedback (cues) to the patient when performing a certain exercise.
The main questions it aims to answer are:
- Will patients with a CVA show a qualitatively better gait pattern after training with a Stride One insole?
- Can patients maintain this improvement in gait pattern without audio feedback at the end of the training?
Participants will
- Receive daily gait rehabilitation using Stride One for 1 week
- The quality of the gait pattern was evaluated at the beginning and at the end of the week, with and without the use of Stride One
- An additional evaluation was performed three to four days after the end of therapy without the use of Stride One
- Immediately after the end of the intervention week, the patient and the treating therapist were asked about their findings regarding the use of Stride One while walking
详细描述
Both therapist and patient reported an improvement in the quality of the foot roll-off pattern in 100% of cases. This improvement was also objectively determined in the data measured by Stride One, with an average of 8% improvement on Stride One general quality parameter, and an average of 25% improvement on Stride One specific quality parameter for the specific patient. Furthermore, 89% of patients indicate that using Stride One helps them to understand their physiotherapist better, and 67% of patients indicate that they can practice more and better with Stride One.
Practicing one week with Stride One generates a positive clinical impact on the gait pattern. A lasting improvement in the gait pattern without using Stride One, three to four days after the intervention, could not be demonstrated in this short time period. Further research is needed to evaluate the effect of Stride One after more long-term use.
Additional research questions are suggested.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •CVA, residentially admitted to the rehabilitation center in Herk-de-Stad, Belgium
- •Older than 18 years of age
- •Gait problems as a result of the CVA
- •Able to walk safely and independently (possibly with a walking aid)
- •Able to understand and sign an information and consent form
排除标准
- •Severe cognitive problems (attention) that make it difficult to understand instructions or follow feedback
- •Hearing problem
结局指标
主要结局
Complete and correct foot roll-off
时间窗: 1 week while daily therapy was given
The first primary endpoint of the study is the complete and correct foot roll-off (detected and interpreted in the Ceriter platform). Stride One provides auditory feedback to the patient, stimulating the patient to achieve a good roll-off of the foot. For each step it measures whether a correct heel-strike, mid-stance and terminal stance are achieved. The aim of Stride One is to teach patients to place their feet correctly, in order to obtain a better roll- off, using positive audio feedback.
Changed walking speed/greater number of steps per minute
时间窗: 1 week while daily therapy was given
次要结局
- Improved functional tests: 3-minute walking test with audio feedback(Before the start of the therapy and immediately after the end of the intervention period)
- Subjective experiences: questionnaires(Post intervention, 2 days after end of the therapy)
- Improved functional tests: 3-minute walking test without audio feedback(Before the start of the therapy, immediately after the end of the intervention period and 2 days after the end of the therapy)
- Improved functional tests: 5x sit-to-stand (seconds)(Before the start of the therapy, immediately after the end of the intervention period and 2 days after the end of the therapy)