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

NCT05900934 | Active Not Recruiting

• 1 other identifier: KA-22060
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Myofascial Release; Exercise Therapy; Movement Disorders

Keywords

myofascial releasing; gait; balance

Outcome Measures

Primary Outcomes (1)

• GAITRite® gait system

  Evaluation of time-distance characteristics of gait

  Eight week

Secondary Outcomes (10)

• Berg Balance Scale

  Eight week

• Posturographic assessment

  Eight week

• The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale

  Eight week

• Roll-over test

  Eight week

• Range of Motion Assessment

  Baseline- End of the eight week

Study Arms (2)

Myofascial Releasing Group

ACTIVE COMPARATOR

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

Sham Myofascial Releasing Group

SHAM COMPARATOR

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

Interventions

Myofascial Releasing Group 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.

Also known as: Myofascial Release

Myofascial Releasing Group

Sham Myofascial Releasing Group OTHER

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

Also known as: Sham Myofascial Release

Sham Myofascial Releasing Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06590, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 38818769 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Movement Disorders

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Yahya Doğan, Dr

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Muhammed Kılınç, Prof

  Hacettepe University

  STUDY CHAIR

• Mert Doğan, PhD

  Akdeniz University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: A double-blind, assessor-blinded and patient-blinded, randomized controlled study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Arm 1: Myofascial Releasing Group Arm 2: Sham Myofascial Releasing Group

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 13, 2023
• Study Start: June 15, 2023
• Primary Completion: June 15, 2024
• Study Completion: September 15, 2024
• Last Updated: February 29, 2024

Record last verified: 2024-02

Locations

TU (1)