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

NCT ID: NCT05900934

Last Updated: 2024-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-15

Study Completion Date

2024-09-15

Brief Summary

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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

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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.

Conditions

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Parkinson Disease Myofascial Release Exercise Therapy Movement Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Arm 1: Myofascial Releasing Group Arm 2: Sham Myofascial Releasing Group
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
A double-blind, assessor-blinded and patient-blinded, randomized controlled study.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Myofascial Releasing Group

Intervention Type OTHER

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.

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.

Group Type SHAM_COMPARATOR

Sham Myofascial Releasing Group

Intervention Type OTHER

The severity of the application is not felt at all according to the numerical rating scale of 0/10.

Interventions

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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.

Intervention Type OTHER

Sham Myofascial Releasing Group

The severity of the application is not felt at all according to the numerical rating scale of 0/10.

Intervention Type OTHER

Other Intervention Names

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Myofascial Release Sham Myofascial Release

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Kutay Kaslı

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yahya Doğan, Dr

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Muhammed Kılınç, Prof

Role: STUDY_CHAIR

Hacettepe University

Mert Doğan, PhD

Role: STUDY_CHAIR

Akdeniz University

Locations

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Hacettepe University

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Kasli K, Dogan M, Ozal C, Dogan Y, Kilinc M, Aksu Yildirim S. The effects of myofascial release in combined with task-oriented circuit training on balance in people with Parkinson's disease: a randomized pilot trial. Neurol Res. 2024 Sep;46(9):848-858. doi: 10.1080/01616412.2024.2360860. Epub 2024 May 31.

Reference Type DERIVED
PMID: 38818769 (View on PubMed)

Other Identifiers

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KA-22060

Identifier Type: -

Identifier Source: org_study_id

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