Clinical trial NCT05900934: The Effects Of Myofascial Release In Combined With Task-Oriented Circuit Training On Balance And Gait In People With Parkinson's Disease
Official title: The Effects of Myofascial Release in Combined With Task-oriented Circuit Training on Balance and Gait in People With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Myofascial Release
Exercise Therapy
Movement Disorders
Keywords: myofascial releasing
gait
balance
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-06-13
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1: Myofascial Releasing Group Arm 2: Sham Myofascial Releasing Group
Primary purpose: TREATMENT

Brief summary: In this study, the investigators 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 participant's 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 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 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 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 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 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 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 Parkinson's disease when applied in combination with a rehabilitation program.

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

Primary outcomes:
measure: GAITRite® gait system
timeFrame: Eight week
Secondary outcomes:
measure: Berg Balance Scale
timeFrame: Eight week
measure: Posturographic assessment
timeFrame: Eight week
measure: The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale
timeFrame: Eight week
measure: Roll-over test
timeFrame: Eight week
measure: Range of Motion Assessment
timeFrame: Baseline- End of the eight week
measure: Timed-up and go test
timeFrame: Eight week
measure: Goal Attainment Scale
timeFrame: Eight week
measure: The Parkinson's disease questionnaire-8
timeFrame: Eight week
measure: Trunk impairment scale
timeFrame: Eight week
measure: Body-Mass Index
timeFrame: Eight week
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Yahya Doğan, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Muhammed Kılınç, Prof
role: STUDY_CHAIR
affiliation: Akdeniz University
name: Mert Doğan, PhD
role: STUDY_CHAIR
References: