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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Parkinson Disease; Movement Disorders; Exercise Therapy; Myofascial Release
• Intervention / Treatment: Other: Myofascial Releasing Group; Other: Sham Myofascial Releasing Group

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.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06590
    • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Myofascial Releasing Group; 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; 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.; Other Names: Myofascial Release
Sham Comparator: Sham Myofascial Releasing Group; 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; The severity of the application is not felt at all according to the numerical rating scale of 0/10.; 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	Eight week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.	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.	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.	Eight week
Roll-over test	Both 360-degree turns are timed with a stopwatch.	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.	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.	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.	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.	Eight week
Body-Mass Index	Participants weight and height will be assessed by investigators and BMI will calculated by investigators.	Eight week

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Principal Investigator: Yahya Doğan, Dr, Hacettepe University; Study Chair: Muhammed Kılınç, Prof, Hacettepe University; Study Chair: Mert Doğan, PhD, Akdeniz University

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2023
• Primary Completion (Estimated): June 15, 2024
• Study Completion (Estimated): September 15, 2024

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: June 2, 2023
• First Posted (Actual): June 13, 2023

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: gait; balance; myofascial releasing
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Movement Disorders
• Other Study ID Numbers: KA-22060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No