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临床试验/NCT05425667
NCT05425667招募中不适用

Sensory System Weighting and Sensory Integration Therapy Training in Patients With Lumbar Spinal Stenosis

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年4月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
Postural balance: Mean velocity

研究概览

简要总结

Lumbar spinal stenosis is a common degenerative disease in the elderly. Patients are often accompanied by paresthesias and decreased musculoskeletal system functions, resulting in disability and increasing the burden of medical care. The balance and walking ability of such patients are affected by the compressed nerves, so it is necessary to reorganize the nerve sensory systems to compensate for the disability caused by lumbar stenosis. It is necessary to strengthen the training of sensory integration ability, but it has not been Studies have investigated which treatments or surgery can improve sensory integration in patients with lumbar stenosis. Therefore, this study will develop a clinical tool to objectively evaluate sensory integration, quantify the sensory integration ability of patients with lumbar stenosis and neurological claudication; The influence and mechanism of the balance ability.

详细描述

Objective 1. To develop a sensory integration assessment tool for patients with lumbar stenosis, in order to explore the distribution ratio of sensory system weights between them and healthy elders of the same age without lumbar stenosis under different balance disturbance stimuli.

Objective 2. To explore the distribution ratio of sensory system weights and long-term tracking of changes in sensory system weights in patients with lumbar stenosis and neurological claudication who received sensory integration training after spinal decompression surgery.

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
50 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 50 and 79 years old
  • Patients with lumbar stenosis and neurological claudication diagnosed according to MRI
  • Timed sit-stand-walk test greater than 9 seconds
  • Can stand independently for more than 30 seconds

排除标准

  • previous lumbar surgery
  • neurological disorder such as stroke or spinal cord injury
  • metabolic disease such as diabetes mellitus
  • vestibular disease such as Meniere's disease.

研究组 & 干预措施

Experimental

Experimental

sensory integration training exercise for improving balance and walking ability of patients with lumbar stenosis and neurological claudication.

干预措施: virtual reality walking training (Other)

结局指标

主要结局

Postural balance: Mean velocity

时间窗: 1 year

The postural balance measurements are performed by using a force platform. The data from the force platform is used to calculate the mean velocity (unit: cm/s).

Postural balance: Ellipse area

时间窗: 1 year

The postural balance measurements are performed by using a force platform. The data from the force platform is used to calculate 95% confidence ellipse area (unit: cm\^2).

Functional assessment: Duration

时间窗: 1 year

Functional assessment is a process that allows for the identification of disability. The data from the functional assessment is used to calculate the duration it took to complete the test (unit: s).

Functional assessment: Walking speed

时间窗: 1 year

Functional assessment is a process that allows for the identification of disability. The data from the functional assessment is used to calculate walking speed (unit: m/s).

Functional assessment: Walking distance

时间窗: 1 year

Functional assessment is a process that allows for the identification of disability. The data from the functional assessment is used to calculate walking distance (unit: m)

Muscle activities

时间窗: 1 year

Electromyography is a technique for evaluating and recording muscle activity. The data from electromyography is used to calculate a normalized value (unit: ratio).

Postural balance: Mean distance

时间窗: 1 year

The postural balance measurements are performed by using a force platform. The data from the force platform is used to calculate the mean distance (unit: cm).

Postural balance:Mean frequency

时间窗: 1 year

The postural balance measurements are performed by using a force platform. The data from the force platform is used to calculate the mean frequency (unit: Hz).

Kinematic variables: Joint angles

时间窗: 1 year

A motion capture system is used to measure the joint kinematics. The data is used to calculate joint angles (unit: degree).

Kinematic variables: Center of mass

时间窗: 1 year

A motion capture system is used to measure the joint kinematics. The data is used to calculate the displacement of the center of mass (unit: cm).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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