Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06536478
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
The Effect of Exercise Intervention on Posture Trunk Flexibility and Spine Function in Patients With Parkinsons Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Exercise Intervention on Posture Trunk Flexibility and Spine Function in Patients With Parkinsons Disease
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Parkinsons 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
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 leftright side-bending motion and the angle between the leftright side-bending and the upright position was subtracted as the value of trunk side-bending range of motion The angle between the leftright 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 cases 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 leftright rotation and the angle between the leftright 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 leftright 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 rightleft 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 eg Parkinsons 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 Parkinsons 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 Parkinsons 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
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 leftright side-bending motion and the angle between the leftright side-bending and the upright position was subtracted as the value of trunk side-bending range of motion The angle between the leftright 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 cases 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 leftright rotation and the angle between the leftright 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 leftright 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 rightleft 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 eg Parkinsons 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 Parkinsons 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 Parkinsons 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None