Parkinson DiseaseNCT05899426
Motor Learning-based Clinical Pilates Rehabilitation Protocol for Patients with Parkinson's Disease
A study testing motor learning based clinical pilates and Conventional Physiotherapy in people with Parkinson Disease, run by European University of Lefke at 1 site in Turkey (Türkiye).
Trial summary
Individuals with Parkinson's disease demonstrate impaired motor learning, including a slower acquisition rate and poor retention, which may result from deficits in cognitive function, especially executive function. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- motor learning based clinical pilates and Conventional Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jun 2023to 15 Jun 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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having modified Hoehn \& Yahr Scale grade 2-3 symptoms
- Be over 45 years old
- Having a score of 24 or 24< on the Mini Mental test
- To be able to read and write in Turkish
- Having at least 2 years Parkinson's Disease
Who cannot join
- Serious mental and psychological disorder
- Significant musculoskeletal disorders
- Lower extremity deformation
- Having another neurological disease
- Drug or dose change during treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Motor Learning-based Clinical Pilates Rehabilitation Protocol for Patients with Parkinson's Disease, Called @parkinsonpilates: Randomised Controlled Trial
Individuals with Parkinson's disease demonstrate impaired motor learning, including a slower acquisition rate and poor retention, which may result from deficits in cognitive function, especially executive function. Considering the reduced motor learning ability in this patient group, exercises should be designed with a focus on strengthening sensory inputs and basic functional training. Therefore, the investigators established this program according to previous experience published study [NCT04063605]. Therefore, the feasibility of this rehabilitation protocol, which combines motor learning and clinical pilates principles and is adapted to the needs of individuals with Parkinson's disease, will be examined.
Read the detailed description
The patients with Parkinson's Disease will be randomly assigned into two groups: Motor Learning based Clinical Pilates (MLCP) Group and Conventional Physiotherapy (CP) Group. Both groups will be treated for 12 weeks. The evaluation of the patients will be done before the beginning of exercise program, midterm evaluation in the 6th week and will be repeated at the end. Also there will be followed up evaluation with the same assessments at the 3rd month. Physical function/motor function of patients will be evaluated with The Unified Parkinson's Disease Rating Scale (UPDRS) III subscale, dynamic balance with Functional Reach Test (FRT), postural control and dynamic balance will also be evaluated with Berg Balance Scale and functional mobility by Timed Up and Go Test. Gait, balance and functional domains of the patients will be evaluated with Gait and Balance Scale (GABS), Nelson foot reaction test will be used for the reaction time.
- Conditions
- Parkinson Disease
- Being tested
- motor learning based clinical pilates, Conventional Physiotherapy
- Keywords
- Parkinson Disease, Exercise
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motor learning based clinical pilatesOther
Also called Parkinsonpilates
The exercises will be created as function and goal. At least one stimulus will be given during each exercise (visual, tactile, auditory or vestibular). 2 different levels were determined for 3 months of treatment, according to the months. As the level increased, the intensity of the exercise increased. In general, the exercise intensity was increased according to the against gravity and the decreasing in the support area.
Conventional PhysiotherapyOther
Also called Control group
This exercise program will include strengthening, stretching, posture exercises, balance and gait exercises. Aim is to improve muscle strength and prevent shortness of muscles. Also, balance and gait exercise aim to improve walking capacity.
| Study group | Role | What they receive |
|---|---|---|
| Motor learning based clinical pilates | Experimental | Participants in this group will receive training for 60 minutes 2 times a week for 12 weeks and will be followed up with the same assessments at the 3rd months after the treatment. Receives: Other: motor learning based clinical pilates |
| Conventional Physiotherapy | Active comparator | Participants in this group will receive training for 60 minutes 2 times a week for 12 weeks and will be followed up with the same assessments at the 3rd months after the treatment. Receives: Other: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nelson Foot Reaction Test
This test is measured using a ruler and this gives the simple reaction time. The participant sits against the wall with the toe at a distance of 2.5 cm and the heel at a distance of 5 cm from the wall. The test administrator holds the reaction ruler between the wall and the participant's foot and releases the ruler as soon as the participant is ready. The participant tries to hold the falling ruler by squeezing it against the wall. It will be measured 20 times. Five best and five worst values will be discarded and the average of the remaining measurement will be taken.
Measured: 5 minutes
Gait and Balance Scale (Untimed Tasks)
Gait and Balance Scale (GABS) consists of historical information and examination of 14 different gait and balance parameters designed to assess the severity of these functional domains. Thirty-five patients with Parkinson's disease (PD), Hoehn and Yahr stages 1 - 3, were tested. Items 1 to 17 GABS are scored on a scale of 0 to 4 (0 being normal and 4 being the worst). Items 18- 24 are scored on a scale 0 to 1 or 0 to 2 (0 being normal and 1 or 2 being abnormal).
Measured: 15 minutes
Gait and Balance Scale (Timed Tasks - Cadence)
Gait and Balance Scale (GABS) consists of timed tasks to assess gait speed and the 'up-and-go' test. Timed tasks provide valuable information about the gait cycle by measuring speed of walking, variation between the normal and fast gait speed, stand-walk-sit time and cadence.
Measured: 2 minutes
Secondary outcomes (4)
Functional reach test
A balance test designed to measure stability limits. The patient is asked to raise the dominant arm 90 ° and place it at the shoulder level and extend as far as it can go forward, without loss of movement or balance in the feet. Reduced ability to reach indicates an increased risk of falling in the future.
Measured: 5 minutes
Timed-up and Go test
When the command is given, the patient gets up from a normal chair, walks 3 meters, turns and walks back to the chair and sits down. The time starts when the command is given and ends when the person sits back in the chair.
Measured: 5 minutes
Berg Balance Scale
This test is used to measure a person\&amp;amp;amp;amp;#39;s static and dynamic balance performance. It is effective in assessing postural control and predicting the risk of falling. It is a 14-item test that uses 0 to 4 sequential scoring for each item. The total score range is from 0 to 56 and a higher score indicates a better balance.
Measured: 15 minutes
The Unified Parkinson&amp;amp;amp;amp;#39;s Disease Rating Scale (UPDRS) III. Subscale
The severity of motor symptoms will be assessed with the UPDRS III. (1) bradykinesia (finger taps, hand movements, rapid alternating movements of hand, leg agility, body bradykinesia and hypokinesia); (2) rigidity; (3) tremor (tremor at rest, action or postural tremor of hands); and (4) axial symptoms (arising from chair, posture, gait, postural stability).
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start25 Jun 2023
- Primary completion20 Mar 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- 2 groups will receive different exercise program for 12 weeks.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- European University of Lefke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beliz Belgen Kaygısız, PT, PhD, Principal investigator, European University of LefkeFahriye Çoban, PT, MSc, Principal investigator, European University of Lefke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899426
- Sponsor's protocol ID
- BAYEK022.05
- Status last verified
- Aug 2024
- First submitted
- 28 May 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Learning-based Clinical Pilates Rehabilitation Protocol for Patients with Parkinson's Disease, Called @parkinsonpilates: Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05899426
- Acronym / sponsor ID
- BAYEK022.05
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- European University of LefkeUniversity, hospital or other
- Study start
- 25 Jun 2023 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 12 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.
Individuals with Parkinson's disease demonstrate impaired motor learning, including a slower acquisition rate and poor retention, which may result from deficits in cognitive function, especially executive function. Considering the reduced motor learning ability in this patient group, exercises should be designed with a focus on strengthening sensory inputs and basic functional training. Therefore, the investigators established this program according to previous experience published study [NCT04063605]. Therefore, the feasibility of this rehabilitation protocol, which combines motor learning and clinical pilates principles and is adapted to the needs of individuals with Parkinson's disease, will be examined.
Detailed description
The patients with Parkinson's Disease will be randomly assigned into two groups: Motor Learning based Clinical Pilates (MLCP) Group and Conventional Physiotherapy (CP) Group. Both groups will be treated for 12 weeks. The evaluation of the patients will be done before the beginning of exercise program, midterm evaluation in the 6th week and will be repeated at the end. Also there will be followed up evaluation with the same assessments at the 3rd month. Physical function/motor function of patients will be evaluated with The Unified Parkinson's Disease Rating Scale (UPDRS) III subscale, dynamic balance with Functional Reach Test (FRT), postural control and dynamic balance will also be evaluated with Berg Balance Scale and functional mobility by Timed Up and Go Test. Gait, balance and functional domains of the patients will be evaluated with Gait and Balance Scale (GABS), Nelson foot reaction test will be used for the reaction time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 groups will receive different exercise program for 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Motor learning based clinical pilates | Experimental | Other: motor learning based clinical pilatesParticipants in this group will receive training for 60 minutes 2 times a week for 12 weeks and will be followed up with the same assessments at the 3rd months after the treatment. |
| Conventional Physiotherapy | Active comparator | Other: Conventional PhysiotherapyParticipants in this group will receive training for 60 minutes 2 times a week for 12 weeks and will be followed up with the same assessments at the 3rd months after the treatment. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having modified Hoehn \& Yahr Scale grade 2-3 symptoms
- Be over 45 years old
- Having a score of 24 or 24< on the Mini Mental test
- To be able to read and write in Turkish
- Having at least 2 years Parkinson's Disease
Key exclusion criteria (5 listed)
- Serious mental and psychological disorder
- Significant musculoskeletal disorders
- Lower extremity deformation
- Having another neurological disease
- Drug or dose change during treatment
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 |
|---|---|---|
| motor learning based clinical pilatesAlso: ParkinsonpilatesThe exercises will be created as function and goal. At least one stimulus will be given during each exercise (visual, tactile, auditory or vestibular). 2 different levels were determined for 3 months of treatment, according to the months. As the level increased, the intensity of the exercise increased. In general, the exercise intensity was increased according to the against gravity and the decreasing in the support area. | Other | Motor learning based clinical pilates |
| Conventional PhysiotherapyAlso: Control groupThis exercise program will include strengthening, stretching, posture exercises, balance and gait exercises. Aim is to improve muscle strength and prevent shortness of muscles. Also, balance and gait exercise aim to improve walking capacity. | Other | Conventional Physiotherapy |
Primary outcome
Nelson Foot Reaction Test
Time frame: 5 minutes
This test is measured using a ruler and this gives the simple reaction time. The participant sits against the wall with the toe at a distance of 2.5 cm and the heel at a distance of 5 cm from the wall. The test administrator holds the reaction ruler between the wall and the participant's foot and releases the ruler as soon as the participant is ready. The participant tries to hold the falling ruler by squeezing it against the wall. It will be measured 20 times. Five best and five worst values will be discarded and the average of the remaining measurement will be taken.
Gait and Balance Scale (Untimed Tasks)
Time frame: 15 minutes
Gait and Balance Scale (GABS) consists of historical information and examination of 14 different gait and balance parameters designed to assess the severity of these functional domains. Thirty-five patients with Parkinson's disease (PD), Hoehn and Yahr stages 1 - 3, were tested. Items 1 to 17 GABS are scored on a scale of 0 to 4 (0 being normal and 4 being the worst). Items 18- 24 are scored on a scale 0 to 1 or 0 to 2 (0 being normal and 1 or 2 being abnormal).
Gait and Balance Scale (Timed Tasks - Cadence)
Time frame: 2 minutes
Gait and Balance Scale (GABS) consists of timed tasks to assess gait speed and the 'up-and-go' test. Timed tasks provide valuable information about the gait cycle by measuring speed of walking, variation between the normal and fast gait speed, stand-walk-sit time and cadence.
4 secondary outcomes
Functional reach test
Time frame: 5 minutes
Timed-up and Go test
Time frame: 5 minutes
Berg Balance Scale
Time frame: 15 minutes
The Unified Parkinson&amp;amp;amp;amp;#39;s Disease Rating Scale (UPDRS) III. Subscale
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Beliz Belgen Kaygısız, PT, PhD principal investigator
European University of Lefke
Fahriye Çoban, PT, MSc principal investigator
European University of Lefke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing motor learning based clinical pilates and Conventional Physiotherapy in people with Parkinson Disease, run by European University of Lefke 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 19 Sep 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Nelson Foot Reaction Test (time frame: 5 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.