Gait Analysis in Patients With Hemiplegia Using Insole Splint.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Stride length
研究概览
简要总结
The goal of this clinical trial is to compare the gait of patients with hemiplegia, with or without the use of insole splint. The main questions it aims to answer are:
Does the insole splint improve the gait of these patients? Does any difference exist in the use of muscles?
Participants will have to walk in the gait analysis' aisle with and without the insole splint, using wireless EMG device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients that can walk with or without the splint, having their first stroke episode at least two months ago and their hospitalisation period does not overcome six months, having also a diagnosis from a neurologist coming with a Brain CT-scan.
- •Patients must have use the insole splint during physiotherapy sessions for at least 1 week before their inclusion in the trial.
- •Patients must be able to communicate and fully understand the instructions given by the researchers.
- •Researchers are going to try to have a sex ratio 50/
- •Patients' age is going to be between 18-70 years.
- •Functional Ambulation Category: FAC > 2
- •Modified Ashworth Scale of the affected lower Limb (MAS): MAS ≤2
- •Normal Gait before the stroke.
排除标准
- •Peripheral Neurological Damage.
- •Past or ongoing orthopedic or reumatologic disease that bothers patient's gait.
- •Past damage of the Central Nervous System.
- •Dermatologic problems or human factors that limitate the use of insole splint.
- •Patients must not have used intramuscular botox injection recently.
- •Patients with low motivation and low perception are also excluded.
结局指标
主要结局
Stride length
时间窗: up to 6 months
Patients are going to walk 15 meters with speed decided from the patient himself. More specific, the investigators are going to count Stride length (a full walking cycle of both feet making 1 step each)
Gait speed
时间窗: up to 6 months
Patients are going to walk 15 metres with speed (meter/second) decided from the patient himself.
Gait cadence
时间窗: up to 6 months
Patients are going to walk 15 meters with speed decided from the patient himself and will measure cadence (number of full steps per minute)
Gait angles
时间窗: up to 6 months
Patients are going to walk 15 meters with speed decided from the patient himself. More specific, the investigators are going to count Ankle angles, Knee angles, Hip angles (in degrees) during gait.
次要结局
未报告次要终点
研究者
Avraam Ploumis
Director of Physical Medicine and Rehabilitation Clinic
University of Ioannina