Motor Learning-based Clinical Pilates Rehabilitation Protocol for Patients With Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Motor Learning-based Clinical Pilates Rehabilitation Protocol for Patients With Parkinson's Disease, Called @Parkinsonpilates: Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05899426
• Other study ID #: BAYEK022.05
• Status: Recruiting
• Phase: N/A
• Start date: June 19, 2023
• Est. completion date: December 25, 2023

Study information

• Verified date: July 2023
• Source: European University of Lefke
• Contact: Fahriye Çoban, PT, MSc
• Phone: 0903926602000
• Email: fcoban[@]eul.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 25, 2023
• Est. primary completion date: December 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Serious mental and psychological disorder

• Significant musculoskeletal disorders

• Lower extremity deformation

• Having another neurological disease

• Drug or dose change during treatment

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• motor learning based clinical pilates
The exercises will be created as function and goal. At least one stimulus will be given during each exercise (visual, tactile, auditory or vestibular). 3 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 Physiotherapy
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.

Locations

Country	Name	City	State
Turkey	European University of Lefke	Mersin

Sponsors (1)

Lead Sponsor	Collaborator
European University of Lefke

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 minutes
Primary	Berg Balance Scale	This test is used to measure a person'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.	15 minutes
Primary	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.	5 minutes
Primary	The Unified Parkinson'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).	15 minutes
Primary	Gait and Balance Scale	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).	15 minutes
Primary	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.	5 minutes