Parkinson DiseaseNCT05900934
The Effects Of Myofascial Release In Combined With Task-Oriented Circuit Training On Balance And Gait In People With Parkinson's Disease
A study testing Myofascial Releasing Group in people with Parkinson Disease and Myofascial Release, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Parkinson Disease, Myofascial Release, Exercise Therapy
- What is being tested?
- Myofascial Releasing Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2023to 15 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Myofascial Releasing Group, Sham Myofascial Releasing Group
- Keywords
- myofascial releasing, gait, balance
- Medical subject headings
- Parkinson Disease, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial Releasing GroupOther
Also called Myofascial Release
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 GroupOther
Also called Sham Myofascial Release
The severity of the application is not felt at all according to the numerical rating scale of 0/10.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sham Myofascial Releasing Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
GAITRite® gait system
Evaluation of time-distance characteristics of gait
Measured: Eight week
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: Eight week
Roll-over test
Both 360-degree turns are timed with a stopwatch.
Measured: Eight week
Range of Motion Assessment
Neck flexion, extension, rotation, lateral flexion, trunk flexion, extension, rotation, lateral flexion and ankle dorsiflexion ROM will be measured.
Measured: Baseline- End of the 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Eight week
Body-Mass Index
Participants weight and height will be assessed by investigators and BMI will calculated by investigators.
Measured: Eight week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start15 Jun 2023
- Primary completion15 Jun 2024 (estimated)
- Study completion15 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm 1: Myofascial Releasing Group Arm 2: Sham Myofascial Releasing Group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kutay Kaslı, Hacettepe University
- Investigators
- Yahya Doğan, Dr, Principal investigator, Hacettepe UniversityMuhammed Kılınç, Prof, Study chair, Hacettepe UniversityMert Doğan, PhD, Study chair, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900934
- Sponsor's protocol ID
- KA-22060
- Status last verified
- Feb 2024
- First submitted
- 23 May 2023
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kasli K, Dogan M, Ozal C, Dogan Y, Kilinc M, Aksu Yildirim S. The Effects of Foam Rolling after Task-Oriented Circuit Training on Gait, Balance, and Range of Motion in Parkinson's Disease: A Randomised Controlled Trial. Neurodegener Dis. 2026;26(2):89-100. doi: 10.1159/000550230. Epub 2025 Dec 26.
PubMed 41452784Kasli 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.
PubMed 38818769
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Myofascial Release in Combined With Task-oriented Circuit Training on Balance and Gait in People With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05900934
- Acronym / sponsor ID
- KA-22060
- Keywords
- myofascial releasing, gait, balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 15 Sep 2024 (estimated)
- First posted
- 13 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Arm 1: Myofascial Releasing Group Arm 2: Sham Myofascial Releasing Group
| Arm | Type | Receives |
|---|---|---|
| Myofascial Releasing Group | Active comparator | Other: Myofascial Releasing GroupThe 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. |
| Sham Myofascial Releasing Group | Sham comparator | Other: Sham Myofascial Releasing GroupIn 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myofascial Releasing GroupAlso: Myofascial ReleaseUsing 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 | Myofascial Releasing Group |
| Sham Myofascial Releasing GroupAlso: Sham Myofascial ReleaseThe severity of the application is not felt at all according to the numerical rating scale of 0/10. | Other | Sham Myofascial Releasing Group |
Primary outcome
GAITRite® gait system
Time frame: Eight week
Evaluation of time-distance characteristics of gait
10 secondary outcomes
Berg Balance Scale
Time frame: Eight week
Posturographic assessment
Time frame: Eight week
The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale
Time frame: Eight week
Roll-over test
Time frame: Eight week
Range of Motion Assessment
Time frame: Baseline- End of the eight week
Timed-up and go test
Time frame: Eight week
Goal Attainment Scale
Time frame: Eight week
The Parkinson's disease questionnaire-8
Time frame: Eight week
Trunk impairment scale
Time frame: Eight week
Body-Mass Index
Time frame: Eight week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Derived from this study: PubMed 41452784Kasli K, Dogan M, Ozal C, Dogan Y, Kilinc M, Aksu Yildirim S. The Effects of Foam Rolling after Task-Oriented Circuit Training on Gait, Balance, and Range of Motion in Parkinson's Disease: A Randomised Controlled Trial. Neurodegener Dis. 2026;26(2):89-100. doi: 10.1159/000550230. Epub 2025 Dec 26.
- Derived from this study: PubMed 38818769Kasli 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yahya Doğan, Dr principal investigator
Hacettepe University
Muhammed Kılınç, Prof study chair
Hacettepe University
Mert Doğan, PhD study chair
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial Releasing Group in people with Parkinson Disease and Myofascial Release, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GAITRite® gait system (time frame: Eight week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05900934, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.