Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05900934
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-29
First Post:
2023-05-23
Brief Title:
The Effects Of Myofascial Release In Combined With Task-Oriented Circuit Training On Balance And Gait In People With Parkinsons Disease
Sponsor:
Hacettepe University
Organization:
Hacettepe University
Study Overview
Official Title:
The Effects of Myofascial Release in Combined With Task-oriented Circuit Training on Balance and Gait in People With Parkinsons Disease
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study the investigators plan to have Parkinsons patients perform exercises according to the task-oriented training method Since recent studies have suggested that task-oriented training should be organized as a series of workstations that allow for more intensive practice each of them has a program content implemented in the form of a station The program will be implemented in 11 different stations with 3 minutes and a 1-minute break at each station 3 days a week for 8 weeks under the supervision and guidance of a physiotherapist The task-oriented training program will be carried out by applying the above-mentioned exercises in the form of stations sequentially within a certain period of time For all exercises the intensity perceived by the individuals will be ensured to be 12-15 points of perceived exertion according to the Borg Perceived Exertion Scale In this way the exercise program can be easily individualized according to the participants pain complaints and functional status In the study after the task-oriented approach foam roller application and myofascial release will be applied at the end of each session
Foam roller application C7-T1 and posterior neck region thoracic spine lumbar spine and right and left sides of the thoracolumbar spine will be applied with a foam roller which is a myofascial release device in each session Each application area will be applied in 3 sets of 60 seconds of application and 30 seconds of rest The intensity of the pressure for the intensity of the application will be subjectively controlled with a target numeric rating scale rating of 710 0 represents no discomfort and 10 represents maximum discomfort In the sham group similar to the literature the intensity of the application will be applied in accordance with the 010 numeric rating scale at the same application sites for the same duration and the same rest intervals
Within the scope of this study participants gait balance rotation time range of motion level of achievement of the treatment goal quality of life and trunk impairment will be evaluated at the beginning of the study and at the end of 8 weeks
Foam roller application C7-T1 and posterior neck region thoracic spine lumbar spine and right and left sides of the thoracolumbar spine will be applied with a foam roller which is a myofascial release device in each session Each application area will be applied in 3 sets of 60 seconds of application and 30 seconds of rest The intensity of the pressure for the intensity of the application will be subjectively controlled with a target numeric rating scale rating of 710 0 represents no discomfort and 10 represents maximum discomfort In the sham group similar to the literature the intensity of the application will be applied in accordance with the 010 numeric rating scale at the same application sites for the same duration and the same rest intervals
Within the scope of this study participants gait balance rotation time range of motion level of achievement of the treatment goal quality of life and trunk impairment will be evaluated at the beginning of the study and at the end of 8 weeks
Detailed Description:
Participants who meet the inclusion criteria will be randomly divided into 2 groups as PH-Myofascial Release Group and PH-Sham Myofascial Release Group as the control arm by closed envelope method In this randomized controlled study the noninvasive application will be performed with Foam rollers for the same duration same muscle area same set intervals and same number of sets in both groups The intensity of the applications will be different for the research arm PH-Myofascial Relaxation Group for the C7-T1 spine and posterior neck region of the body thoracic spine lumbar spine thoracolumbar spine right and left sides of the body according to the Numeric Pain Scale 710 and for the control arm PH- Sham Myofascial Relaxation Group 010 intensity on the same scale will be applied as applied in the literature After the exercise application called task-oriented training protocol is applied to both groups foam roller application time will be applied to each application area as 3 sets of 60 s applications and 30 s rest The application will be performed 3 days a week for 8 weeks under the supervision of a physiotherapist Task-oriented training It has a program content consisting of coming from sitting to standing standing get up and walk exercise walking exercise on the inclined ground step exercise slalom exercise stair exercise touching different points in the mirror exercise reaching exercise boxing exercise balance exercise on moving ground mat exercise writing eating exercise each of which is applied in the form of a station Since the limitation in the trunk in Parkinsons disease may also be caused by non-neural structures it is curious to evaluate the effects of myofascial release The effects of myofascial release when applied in combination with a task-oriented exercise approach compared to the sham application have not yet been shown on basic motor parameters such as balance and gait in neurological diseases Based on these premises the aim of the study was to evaluate the effects of foam roller application in patients with Parkinsons disease when applied in combination with a rehabilitation program
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None