Overview of the study design
This study will be a randomized controlled study, and it was approved by the Ethical Research Committee of the European University of Lefke (No: BAYEK022.05). Since this study is a part of the PhD thesis study, data collecting will be monitored every 6 months by the Thesis Monitoring Committee. All participants will be provided signed a consent form prior to participation, and the rights of the participants will be protected. The data of the study will be collected at the European University of Lefke Medical Center and Yenikent Physiotherapy and Rehabilitation Center, Nicosia. This study has been registered in ClinicalTrials.gov as NCT05899426. The flow chart of the study is shown in Fig.1. The present protocol used the SPIRIT reporting guidelines [15] which can be viewed in supplementary file 1.
Participants and recruitment
The study sample will be individuals with PD aged 45 to 80 years according to Hoehn & Yahr stage 2-3 which diagnosed by the neurologist and who meet the inclusion criteria and agree to participate in the study. Prior to study, all participants are going to be informed about the study in detail and they are going to be asked to sign the consent form by the physiotherapist. Data collection is going to be carried out by face to face.
Inclusion criteria for the research:
To be eligible for participation, individuals must exhibit symptoms ranging from grade 2 to 3 on the modified Hoehn & Yahr Scale, be aged 45 or above, score either 24 or above on the Mini Mental test, possess proficiency in reading and writing Turkish, and have a confirmed diagnosis of PD for a minimum duration of 2 to 3 years.
Exclusion criteria for the research:
Exclusion criteria encompass individuals with severe mental or psychological disorders, limb deformities, any neurological condition besides Parkinson's Disease, alterations in medication or dosage throughout the treatment phase, and notable musculoskeletal ailments.
Intervention
Both groups will undergo training sessions lasting 60 minutes, twice a week, for a duration of 12 weeks. Subsequently, both groups will be subjected to identical assessments at the conclusion of the 12-week treatment period to evaluate the outcomes. Also there will be midterm evaluation in the 6th week. The number of exercise repetitions at each level is fixed at 20 times. Patients will be given a 30-second rest period between each 20 repetitive exercises.
Participants cannot undergo any other physiotherapy or exercise interventions during the trial.
Conventional Physiotherapy Group
The CP group will engage in established exercises tailored for Parkinson's disease management. This regimen will encompass activities targeting muscle strengthening, flexibility, posture enhancement, and balance and gait improvement. The primary objective is to bolster muscle strength, enhance walking proficiency, and mitigate muscle tightness. Additionally, this cohort will serve as the control group for our study.
Parkinsonpilates Group
Individuals with Parkinson's disease will participate in the motor learning-based clinical pilates group, which we will be called as the Parkinsonpilates, as the intervention group. The Parkinsonpilates is a clinical pilates training designed to improve motor learning, postural stability, and gait, may be beneficial for individuals with Parkinson's disease (PD).
The exercise routines will be designed with specific functions and objectives in mind. Each exercise session will incorporate at least one form of stimulus, whether visual, tactile, auditory, or vestibular. Over the course of the 12-week treatment period, two distinct levels have been established, and participants demonstrating notable progress during the midterm evaluation will advance to level 2 exercises. As the levels progress, the intensity of the exercises will correspondingly increase. Generally, this escalation in intensity will be determined by factors such as the degree of resistance against gravity and the reduction in supportive elements. The Parkinsonpilates protocol is shown in Appendix 1.
Due to the importance of intensive repetition for the motor learning, the patient will be asked to do the mini exercises given to the patient under the home-based exercise program once a day and four days a week. Both groups will be given a mini-exercise program with 10 repetitions of maximum 30 minutes.
If the participants have to change the dose of medication during treatment or want to quit the study, they will discontinue from the study.
Outcome Measurements
The schedule and time frame of the entire study evaluation process are listed in detail in Table1.
Physical and sociodemographic characteristics
Characteristic informations such as gender, age, weight, height, body mass index (BMI), background, family history, smoking and alcohol habits, education status, marital status, exercise habits, hobbies, Parkinson's disease duration, history of falling will be recorded as a form.
Standardized Mini Mental State Test
This test will be used testing patients for cognitive status and eligibility of the study [16]. It is a test applied to the elderly that provides information about the evaluation of cognitive disorders and the course of dementia syndromes [17,18]. Patients need to score at least 24 in order to understand and apply the exercises.
Modified Hoehn & Yahr Staging
The stage of disease will be rated on the Hoehn and Yahr scale [19]. It is a scale that provides information in a short time in determining the clinical status and symptoms of the patient in Parkinson's Disease [20].
The Unified Parkinson’s Disease Rating Scale
The UPDRS stands as the prevailing scale employed for assessing Parkinson's patients, renowned for its widespread usage. It comprises four distinct sections, encompassing aspects of emotion and thought, along with Top of Form
(16 points in total), motor (92 points in total), daily life (52 points in total) and treatment complication (23 points in total). In this scale, which has a scoring system between 0 and 4 points, an increase in the total score indicates an increase in PD symptoms. This test also will be determined patient’s disease severity and progression [21,22].
Functional Mobility
The assessment of functional mobility will be conducted through the TUG (Timed Up and Go test), a reliable and validated. Participants will be asked to rise from a standard chair upon hearing the command "Go," walk a 3 meters, execute return to the chair, and resume a seated position. Timing for the test will commence with the "Go" command and cease upon the participants' sit to the chair. This procedure will be repeated 3x, and the shortest completion record will be documented [23,24].
Balance
Assessment of both static and dynamic balance will be conducted through the utilization of the Berg Balance Test (BBS) [25] and the Functional Reach Test (FRT) [26], respectively. This scale consists of 14 items, each scored sequentially from 0 to 4, commonly employed for assessing postural control and predicting fall risk among the elderly population. The highest score is 56, with indicative of better balance and reduced risk of falls.
Physical Function / Motor Function
The assessment of physical function will be carried out using the UPDRS III subscale [21,22]. Evaluation of motor symptom severity will be conducted using the UPDRS III, either preceding or following the experiment. For a comprehensive analysis, diverse subscores of the UPDRS III will be taken into account. These include bradykinesia, which evaluates tasks like finger taps, hand movements, rapid alternating movements of the hand, and leg agility; rigidity; tremor, which assesses tremor at rest, action-induced tremor, or postural tremor of the hands; and axial symptoms, which pertain to difficulties such as rising from a chair, maintaining posture, walking, and postural stability.
Walking Capacity
The Gait and Balance Scale (GABS) comprises both historical data and examination of 14 distinct parameters related to gait and balance, aimed at evaluating the severity of these functional aspects. A cohort of thirty-five PD patients, ranging from Hoehn and Yahr stages 1 to 3, underwent testing [27]. Scores on items 1 to 17 of the GABS are assigned on a scale from 0 to 4, with 0 representing normal function and 4 indicating the most severe impairment. Items 18 to 24 are scored on a scale from 0 to 1 or 0 to 2, with 0 indicating normal function and 1 or 2 signifying abnormal findings.
Reaction Time
The Nelson Foot Reaction Test (NFRT) will be employed to gauge reaction time in response to visual stimuli. This assessment utilizes a ruler to determine simple reaction time. During the test, participants sit with their backs against a wall, positioning their toes 2.5 cm away and their heels 5 cm away from the wall. The participant holds the reaction ruler in place between the wall and the participant's foot, releasing it when is prepared. The participant's task is to catch the falling ruler by pressing it against to the wall. This procedure will be repeated 20 times, with the exclusion of the five best and five worst measurements, and the average of the remaining trials will be calculated [28].
Reaction Time = √ 2 x Distance from which the ruler falls / Gravity-Dependent Velocity
Reaction Time = √2 x Distance(cm) / 980 sec.
Sample size calculation
The calculation of sample size was determined by taking the degree of relationship between the Timed up & Go Test measurements according to the Pandya et al., to be obtained from the group given the Conventional physiotherapy and the group given the Parkinsonpilates, in other words, the effect size was 1.26, that is, the effect size (Cohen d=1.260) [29]. Accordingly, the total number of people to be recruited is calculated as 30. However, the sample size was obtained as 36, taking into account the people who may drop out of the study. No data analysis will be perfromed the participants who discontinue of the study. The power of the test was taken as (1-β)=0.90 and α=0.05, and the sample size was obtained with the help of the G*Power program to examine whether there was a difference in terms of TUG test measurement between PD who received Parkinsonpilates and Conventional physiotherapy.
Randomization and allocation concealment
The eligible participants will be randomly allocated to either the Parkinsonpilates group or the Conventional physiotherapy group by using the Stratified Randomization Method and the Block Randomization Method which is a computer-based randomization tool (www.randomization.com). The Block Randomization will be performed on the participants who are divided into clusters. Therefore, randomization will be done after the participants have been evaluated. The Stratified Randomization method will be used so that there is no difference in the pre-test between groups due to the severity of different symptoms in individuals with Parkinson's Disease. Therefore, we will collect the UPDRS subscores of symptoms that may affect the outcome of treatment and divide them into categories. So, for the stratify, we took the sum of the Gait and balance and Freezing scores from Subscale II and the sum of the Rigidity in the neck, upper extremity and the Lower Extremity scores from Subscale III. According to the scores, we divided them into categories as ‘Symptom 1, 2, 3’, ranging from mild to high severity. To enter into block randomization, we divided the stratified clusters into the groups and gave them abbreviations.
-G1S1: Conventional Physiotherapy Group with Symptom I
-G1S2: Conventional Physiotherapy Group with Symptom 2
-G1S3: Conventional Physiotherapy Group with Symptom 3
-G1S1: Parkinsonpilates Group with Symptom I
-G1S2: Parkinsonpilates Group with Symptom 2
-G1S3: Parkinsonpilates Group with Symptom 3
All 3 clusters must be equally present in both groups. Since each participant must be attended once, 6 subjects must be entered per block. As a result, subjects will be clustered based on the sum of the UPDRS specific subscores and then will be included in the Block Randomization. The block randomization results are given below. As a result of the participants' evaluations, they will be assigned to the group sequentially according to their cluster. The allocation order will be like the blocks below. After evaluations are made by the physiotherapist, participants will be assigned to interventions.
I.Block: G1S3 –G1S1- G2S3 -G2S1 – G2S2 – G1S2
II.Block: G1S3 - G2S2 - G1S1 - G1S2 - G2S3 - G2S1
III.Block: G2S2 - G2S3 - G1S3 - G1S2 - G2S1 - G1S1
IV. Block: G1S2 - G1S1 - G2S2 - G1S3 - G2S3 - G2S1
V.Block: G1S1 - G1S3 - G2S3 – G2S2 - G1S2 – G2S1
VI.Block: G1S2 - G2S2 - G2S3 - G1S1 - G1S3 - G2SI
Statistical analysis
The statistical analysis will be conducted using the SPSS (IBM SPSS Statistics 23) software package. The Shapiro-Wilk goodness-of-fit test will be employed to assess the conformity of numerical variable distributions to the normal distribution. Descriptive statistics, including mean, standard deviation, minimum, and maximum values, will be provided for variables demonstrating a normal distribution. Conversely, for variables not adhering to a normal distribution, descriptive statistics such as median, interquartile range, minimum, and maximum values will be presented. If the assumptions of normality and homogeneity of variances are provided in order to examine the changes in numerical measurements compared to the treatment and control groups over time, repeated measurements will be examined with two-way analysis of variance. If the assumptions are not met, the Mann-Whitney U test will examine whether there is a difference in numerical measurements between the control and the study group, and the change in numerical measurements for each group over time will be examined with the Wilcoxon test. Whether there is a difference between the groups in terms of categorical variables (gender, etc.) will be examined with the Chi-square (χ^2) test. The statistical significance level will be accepted as p <0.05.