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临床试验/NCT06536478
NCT06536478招募中不适用

The Effect of Exercise Intervention on Posture, Trunk Flexibility and Spine Function in Patients With Parkinson's Disease

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年9月28日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
postural alignment of frontal and sagittal plance

研究概览

简要总结

The primary goal of this clinical trail is to compare the effect of a five-week specific motor interventions on the postural alignment, trunk range of motion and spine function in patients with Parkinson's disease. The secondary goal is to investigate the effect of specific motor interventions on pain, balance, gait, and quality of life.

Participants will:

be randomly allocated to a control group or an exercise group and will perform 50 minutes of exercise twice a week, including stretching, core exercises, gross motor movements and balance exercises for 5 weeks. Each group will be assessed for posture, trunk range of motion, spine function, pain, balance, gait, and quality of life before and after the intervention.

详细描述

Participants will be randomly allocated to a control group or an exercise group and will perform 50 minutes of exercise twice a week, including stretching, core exercises, gross motor movements and balance exercises for 5 weeks. Each group will be assessed for posture, trunk range of motion, spine function, pain, balance, gait and quality of life before and after the intervention.

Posture evaluation was performed by measuring the angles of Flexion and Side-bending, by placing marks on the Spinal process of 7th cervical spine and the Spinal process of 5th lumbar spine, and by taking images of the Sagittal plane and Frontal plane. A digital flat-panel camera was used to take images in the sagittal plane and the coronal plane, and the angle between the line connecting the seventh cervical process of the spine and the fifth lumbar process of the lumbar spine and the vertical line was measured on the images; the angle in the coronal plane was defined as the anterior tilt angle, and that in the coronal plane was defined as the lateral bending angle.

Trunk flexion range of motion is measured using a goniometer and a tape measure in the following manner: Trunk flexion range of motion is measured with the trunk flexed anteriorly: the starting position of the case is standing in an upright position, and the tape measure is fixed to the seventh cervical vertebrae and the first vertebrae on the spinous processes, then the case is asked to relax the trunk forward to the end of the flexion without anteriorly tilting the pelvis. The difference between the tape measure in forward bending and upright position was taken as the value of trunk anterior tilt mobility. Trunk extension range of motion: The starting position of the case was standing in an upright position, and a tape measure was fixed on the spinous processes of the seventh cervical vertebrae and the first vertebrae of the recommended vertebrae. After the case was asked to relax the trunk with both hands and bend the trunk back to the bottom without tilting the pelvis posteriorly, and the difference between the posterior bending and the tape measure in the upright position was used as a value of the trunk extension range of motion. Trunk side-bending range of motion: The starting position of the case was standing upright, the center of the joint goniometer was aligned with the spinal process of the first segment of the recommended vertebrae of the case, one side of the goniometer was perpendicular to the floor, and the other side was aligned with the seventh segment of the cervical vertebrae of the case, the case was asked to make a left/right side-bending motion, and the angle between the left/right side-bending and the upright position was subtracted as the value of trunk side-bending range of motion. The angle between the left/right lateral bend and the upright position was subtracted to obtain the value of trunk lateral bending activity. Trunk rotation range of motion: With the case in a seated but not reclined position, the center of the joint goniometer was aligned with the center of the case's head, with one side of the goniometer parallel to the line of the iliac crest of the pelvis, and the other side parallel to the line of the shoulder crests on both sides. One side of the goniometer was parallel to the line of the iliac crest of the pelvis and the other side was parallel to the line of the shoulder crests on both sides of the body. The case was asked to perform a left/right rotation, and the angle between the left/right rotation and the seated position was subtracted to obtain a value for the degree of torso rotation.

Spinal function is assessed by evaluating the functional activities related to the spine, including Functional axial rotation and Supine to and from standing. The Functional Axial Rotation Test is performed by asking the patient to use a Cervical Range of Motion (CROM) device in a sitting position to measure the angle of rotation of the case when viewed from the left/right side. The lying to standing test is performed by asking the patient to use a Cervical Range of Motion (CROM) device to measure the angle of rotation of the case when viewed from the right/left side. The Lying to Standing Test measures the time taken by the case to move from standing to lying and lying to standing.

Pain was assessed using the Visual Analogue Scale , VAS, which asks the patient about the degree of low back pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
30 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hoehn-Yahr classification 2 to 3
  • Regular compliance with medication program
  • Stable medical condition and vital signs, conscious
  • Be able to follow instructions.

排除标准

  • Cognitive impairment or dementia who are unable to cooperate with therapy or functional assessment
  • Patients with musculoskeletal injuries or surgeries that have resulted in limited mobility
  • Patients with physician-diagnosed cardiorespiratory disorders with activity limitations
  • Patients with acute neurological disorders.

结局指标

主要结局

postural alignment of frontal and sagittal plance

时间窗: before and immediately after the intervention

The angles of Flexion and Side-bending of the trunk in degrees

Supine to and from sitting

时间窗: before and immediately after the intervention

The time of supine to and from sitting is measured in seconds

range of motion of trunk flexion and side-bending

时间窗: before and immediately after the intervention

The range of motion of trunk flexion and side-bending will be evaluated in degrees

次要结局

  • 10 meter gait speed(before and immediately after the intervention)
  • the short version of the Parkinson's Disease Questionnaire (PDQ-8)(before and immediately after the intervention)
  • Visual Analogue Scale of low back pain(before and immediately after the intervention)
  • Tinetti Mobility Test (TMT)(before and immediately after the intervention)
  • Falls Efficacy Scale International (FES-I)(before and immediately after the intervention)
  • The Shortened Version of the Balance Evaluation Systems Tests (Mini-BEST)(before and immediately after the intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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