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

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
motor learning based clinical pilates
Conventional Physiotherapy
Sponsored by
European University of Lefke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, Exercise

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • European University of LefkeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Motor learning based clinical pilates

Conventional Physiotherapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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).
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).
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.

Secondary Outcome Measures

Full Information

First Posted
May 28, 2023
Last Updated
July 10, 2023
Sponsor
European University of Lefke
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1. Study Identification

Unique Protocol Identification Number
NCT05899426
Brief Title
Motor Learning-based Clinical Pilates Rehabilitation Protocol for Patients With Parkinson's Disease
Official Title
Motor Learning-based Clinical Pilates Rehabilitation Protocol for Patients With Parkinson's Disease, Called @Parkinsonpilates: Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 19, 2023 (Actual)
Primary Completion Date
December 25, 2023 (Anticipated)
Study Completion Date
December 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European University of Lefke

4. Oversight

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

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 groups will receive different exercise program for 12 weeks.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Motor learning based clinical pilates
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional Physiotherapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
motor learning based clinical pilates
Other Intervention Name(s)
Parkinsonpilates
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Physiotherapy
Other Intervention Name(s)
Control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Timed-up and Go test
Description
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.
Time Frame
5 minutes
Title
Berg Balance Scale
Description
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.
Time Frame
15 minutes
Title
Functional reach test
Description
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.
Time Frame
5 minutes
Title
The Unified Parkinson's Disease Rating Scale (UPDRS) III. Subscale
Description
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).
Time Frame
15 minutes
Title
Gait and Balance Scale
Description
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).
Time Frame
15 minutes
Title
Nelson Foot Reaction Test
Description
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.
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fahriye Çoban, PT, MSc
Phone
0903926602000
Email
fcoban@eul.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Beliz Belgen Kaygısız, PT, PhD
Phone
0903926602000
Email
bkaygisiz@eul.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beliz Belgen Kaygısız, PT, PhD
Organizational Affiliation
European University of Lefke
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fahriye Çoban, PT, MSc
Organizational Affiliation
European University of Lefke
Official's Role
Principal Investigator
Facility Information:
Facility Name
European University of Lefke
City
Mersin
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fahriye Çoban, PT, MSc

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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