Clinical trial NCT06536478: The Effect of Exercise Intervention on Posture, Trunk Flexibility and Spine Function in Patients With Parkinson's Disease
Official title: The Effect of Exercise Intervention on Posture, Trunk Flexibility and Spine Function in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
exercise
posture
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

The Shortened Version of the Balance Evaluation Systems Tests (Mini-BEST) is used to evaluate balance in cases of balance impairment (e.g., Parkinson's disease, brain injury, vestibular disorders, stroke, or multiple sclerosis). The assessment consists of four sub-balance systems with 14 items each scored 0, 1, or 2 depending on performance, ranging from 0 to 28, with higher scores indicating better balance. The four sub-balance systems included in the test are Anticipatory postural adjustments, Reactive postural control, Sensory orientation and Dynamic gait.

Walking speed was assessed using the 10 m walk test, which involves walking a distance of 14 meters at a comfortable speed and recording the time taken from the second to the twelfth meter in order to calculate the walking speed of the case, with the use of a walking aid if necessary.

The gait assessment will record the parameters of walking and assess them using the Tinetti Mobility Test (TMT). The TMT is used to assess the gait performance of elderly people, people with Parkinson's disease, brain injury, stroke or multiple sclerosis. The assessment is performed by asking the patient to walk a distance of 25 feet in a straight line at a comfortable speed. The administrator can either directly observe or video-record the gait of the patient, or use a walking aid if necessary. The assessment includes the observation of hesitancy to start walking, height of the raised foot, gait length, gait symmetry, continuity of stride, walking path, trunk stability, and width of stride, with a score of 0, 1, or 2 for each item. Each item was scored as 0, 1 or 2, ranging from 0 to 12, with higher scores indicating a more problem-free gait.

Quality of life is assessed using the short version of the Parkinson's Disease Questionnaire (PDQ-8). The PDQ8 is a self-completion questionnaire with eight questions covering eight domains, including activities of daily living, exercise, cognition, social support, communication, emotional well-being, shame, and feelings of physical discomfort, with the lower the score, the better the quality of life and health.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: postural alignment of frontal and sagittal plance
timeFrame: before and immediately after the intervention
measure: range of motion of trunk flexion and side-bending
timeFrame: before and immediately after the intervention
measure: Supine to and from sitting
timeFrame: before and immediately after the intervention
Secondary outcomes:
measure: Visual Analogue Scale of low back pain
timeFrame: before and immediately after the intervention
measure: The Shortened Version of the Balance Evaluation Systems Tests (Mini-BEST)
timeFrame: before and immediately after the intervention
measure: 10 meter gait speed
timeFrame: before and immediately after the intervention
measure: Tinetti Mobility Test (TMT)
timeFrame: before and immediately after the intervention
measure: the short version of the Parkinson's Disease Questionnaire (PDQ-8)
timeFrame: before and immediately after the intervention
measure: Falls Efficacy Scale International (FES-I)
timeFrame: before and immediately after the intervention
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital Hsinchu Branch
Study officials:
References:
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