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

Primary Purpose

Parkinson Disease, Myofascial Release, Exercise Therapy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Myofascial Releasing Group
Sham Myofascial Releasing Group
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring myofascial releasing, gait, balance

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Myofascial Releasing Group

Sham Myofascial Releasing Group

Arm 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.

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.

Outcomes

Primary Outcome Measures

GAITRite® gait system
Evaluation of time-distance characteristics of gait

Secondary Outcome Measures

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.
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.
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.
Roll-over test
Both 360-degree turns are timed with a stopwatch.
Range of Motion Assessment
Neck flexion, extension, rotation, lateral flexion, trunk flexion, extension, rotation, lateral flexion and ankle dorsiflexion ROM will be measured.
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.
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.
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.
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.

Full Information

First Posted
May 23, 2023
Last Updated
June 2, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05900934
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 15, 2023 (Anticipated)
Primary Completion Date
June 15, 2024 (Anticipated)
Study Completion Date
September 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In this study, we 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 person's pain, complaints, and functional status. In our 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 our 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
Volunteers 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, 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 applied to both groups, foam roller application time will be applied to each application area as 3 sets of 60 s application 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 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 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 our study was to evaluate the effects of foam roller application in patients with Parkinson's disease when applied in combination with a rehabilitation program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Myofascial Release, Exercise Therapy, Movement Disorders
Keywords
myofascial releasing, gait, balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Arm 1: Myofascial Releasing Group Arm 2: Sham Myofascial Releasing Group
Masking
ParticipantOutcomes Assessor
Masking Description
A double-blind, assessor-blinded and patient-blinded, randomized controlled study.
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Myofascial Releasing Group
Arm Type
Active Comparator
Arm 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.
Arm Title
Sham Myofascial Releasing Group
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Myofascial Releasing Group
Other Intervention Name(s)
Myofascial Release
Intervention Description
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
Intervention Name(s)
Sham Myofascial Releasing Group
Other Intervention Name(s)
Sham Myofascial Release
Intervention Description
The severity of the application is not felt at all according to the numerical rating scale of 0/10.
Primary Outcome Measure Information:
Title
GAITRite® gait system
Description
Evaluation of time-distance characteristics of gait
Time Frame
Baseline- End of the eight week
Secondary Outcome Measure Information:
Title
Berg Balance Scale
Description
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.
Time Frame
Baseline- End of the eight week
Title
Posturographic assessment
Description
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.
Time Frame
Baseline- End of the eight week
Title
The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale
Description
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.
Time Frame
Baseline- End of the eight week
Title
Roll-over test
Description
Both 360-degree turns are timed with a stopwatch.
Time Frame
Baseline- End of the eight week
Title
Range of Motion Assessment
Description
Neck flexion, extension, rotation, lateral flexion, trunk flexion, extension, rotation, lateral flexion and ankle dorsiflexion ROM will be measured.
Time Frame
Baseline- End of the eight week
Title
Timed-up and go test
Description
The timed up-and-go test will be measured without dual-task conditions and with cognitive and motor dual-task conditions.
Time Frame
Baseline- End of the eight week
Title
Goal Attainment Scale
Description
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.
Time Frame
Baseline- End of the eight week
Title
The Parkinson's disease questionnaire-8
Description
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.
Time Frame
Baseline- End of the eight week
Title
Trunk impairment scale
Description
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.
Time Frame
Baseline- End of the eight week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kutay Kaşlı, MSc
Phone
+905399335533
Email
kutaykasli@karatekin.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Sibel Aksu Yıldırım, Prof
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yahya Doğan, Dr
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Muhammed Kılınç, Prof
Organizational Affiliation
Hacettepe University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mert Doğan, PhD
Organizational Affiliation
Akdeniz University
Official's Role
Study Chair
Facility Information:
Facility Name
Hacettepe University
City
Ankara
ZIP/Postal Code
06590
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammed Kılınç, Prof
Phone
+90-312-305 15 77
Ext
+90
Email
muhammed.kilinc@hacettepe.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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