ClinicalTrials.Veeva

Menu

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

H

Hacettepe University

Status

Active, not recruiting

Conditions

Exercise Therapy
Movement Disorders
Parkinson Disease
Myofascial Release

Treatments

Other: Myofascial Releasing Group
Other: Sham Myofascial Releasing Group

Study type

Interventional

Funder types

Other

Identifiers

NCT05900934
KA-22060

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

36 participants in 2 patient groups

Myofascial Releasing Group
Active Comparator group
Description:
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.
Treatment:
Other: Myofascial Releasing Group
Sham Myofascial Releasing Group
Sham Comparator group
Description:
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.
Treatment:
Other: Sham Myofascial Releasing Group

Trial contacts and locations

1

Loading...

Central trial contact

Kutay Kaşlı, MSc; Sibel Aksu Yıldırım, Prof

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems