The Effects Of Myofascial Release In Combined With Task-Oriented Circuit Training On Balance And Gait In People With Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
In this study, we plan to have Parkinson's 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 person's pain, complaints, and functional status. In our 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 7/10 (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 0/10 numeric rating scale, at the same application sites, for the same duration and the same rest intervals. Within the scope of our 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
-----------------
Volunteers 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, 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 7/10 and for the control arm (PH- Sham Myofascial Relaxation Group) 0/10 intensity on the same scale will be applied as applied in the literature. After the exercise application called task-oriented training protocol applied to both groups, foam roller application time will be applied to each application area as 3 sets of 60 s application 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 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 Parkinson's 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 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 our study was to evaluate the effects of foam roller application in patients with Parkinson's disease when applied in combination with a rehabilitation program.

Official Title
-----------------
The Effects of Myofascial Release in Combined With Task-oriented Circuit Training on Balance and Gait in People With Parkinson's Disease

Conditions
-----------------
Parkinson Disease, Myofascial Release, Exercise Therapy, Movement Disorders

Intervention / Treatment
-----------------
* Other: Myofascial Releasing Group
* Other: Sham Myofascial Releasing Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with Parkinson's Disease by a specialist physician, In a stable period in terms of motor fluctuations and drug treatment Severity of the disease (1-3 according to Hoehn & Yahr) staging No other neurological disease Cognitive status of 24 and above according to the Mini-Mental State Evaluation (MMSE) test No change in Parkinson's disease-related medications or doses during the study Volunteering to participate in the study and giving written informed consent Exclusion Criteria: Hearing and visual impairment, orthopedic, cardiopulmonary and additional neurological diseases that prevent participation in exercises Lack of independent ambulation Using a brain pacemaker for Parkinson's disease Continue with another rehabilitation program The occurrence of any health problem during the assessments and exercise training Failure to attend three consecutive sessions and a total of five sessions during the 24-session treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Arm 1: Myofascial Releasing Group Arm 2: Sham Myofascial Releasing Group
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Myofascial Releasing Group<br>The intensity of application is important for foam rollers. For intensity, the intensity of the pressure will be determined by a subjective 7/10 target numeric rating scale rating (0 representing no discomfort and 10 representing maximum discomfort) and applied at the end of each session. | Other: Myofascial Releasing Group<br>* Using a subjective 7/10 target numeric rating scale rating (0 representing no discomfort and 10 representing maximum discomfort), the intensity of foam roller application can be determined. This intensity defines an application intensity that is mildly painful for the participant and appropriate according to previous literature.<br>* Other names: Myofascial Release;|
| Sham Comparator: Sham Myofascial Releasing Group<br>In the sham group, similar to the literature, the intensity will be applied with foam rollers in accordance with the 0/10 numerical rating scale, to the same application areas, for the same duration and with the same rest intervals. | Other: Sham Myofascial Releasing Group<br>* The severity of the application is not felt at all according to the numerical rating scale of 0/10.<br>* Other names: Sham Myofascial Release;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GAITRite® gait system | Evaluation of time-distance characteristics of gait | Baseline- End of the eight week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Berg Balance Scale | It is used to assess balance in the elderly and to determine the risk of falls. In the test consisting of 14 items, 0 points are given when the individual cannot perform the activity at all, and 4 points are given when the individual completes the activity independently. The maximum total score is 56. 0 to 20 points indicate a high risk of falling and impaired balance; 21 to 40 points indicate a moderate risk of falling and acceptable balance. 41 and above indicates good balance and minimal fall risk. | Baseline- End of the eight week | 
| Posturographic assessment | With the Bertec Balance Check ScreenerTM force platform system (BP5050, Bertec Co., Columbus, OH, USA), stability limits in 4 different directions (front, back, right, left) will be evaluated on hard ground with eyes open and hard ground with eyes closed and also on soft ground. | Baseline- End of the eight week | 
| The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale | It evaluates Parkinson's disease in terms of mental and emotional state, motor examination, activities of daily living and treatment complications. A higher score indicates worse disease severity. | Baseline- End of the eight week | 
| Roll-over test | Both 360-degree turns are timed with a stopwatch. | Baseline- End of the eight week | 
| Range of Motion Assessment | Neck flexion, extension, rotation, lateral flexion, trunk flexion, extension, rotation, lateral flexion and ankle dorsiflexion ROM will be measured. | Baseline- End of the eight week | 
| Timed-up and go test | The timed up-and-go test will be measured without dual-task conditions and with cognitive and motor dual-task conditions. | Baseline- End of the eight week | 
| Goal Attainment Scale | After the treatment, it allows patients to score the extent to which their individual goals have been achieved. GAS gives individuals the ability to construct their own outcome measures; this is in contrast to measures that are based on a standard set of tasks. Scoring, however, is performed in a standardised way which in turn allows for statistical analysis.GAS comprises of goals divided into a 5-point scale from -2 to +2. | Baseline- End of the eight week | 
| The Parkinson's disease questionnaire-8 | It is an 8-question short form of the 39-item Parkinson's Disease Questionnaire developed specifically for the assessment of quality of life in Parkinson's disease. | Baseline- End of the eight week | 
| Trunk impairment scale | It assesses static and dynamic sitting balance and trunk coordination. This scale comprises 17 items. The total score ranges from a minimum of 0 to a maximum 23 points, higher scores indicate better performance. | Baseline- End of the eight week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
myofascial releasing, gait, balance