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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04063605
Other study ID # ÜEK/32/02/03/1819/01
Secondary ID ÜEK/32/02/03/181
Status Completed
Phase N/A
First received
Last updated
Start date September 16, 2019
Est. completion date January 21, 2020

Study information

Verified date March 2021
Source European University of Lefke
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Many studies showed that clinical pilates exercises has positive effects on static and dynamic balance of different populations. It was suggested that this type of exercise reduce the risk of falls and physical damage. It also helps prevention of kyphotic posture. Parkinson's patients have both balance and postural problems but no study investigated the effect of clinical pilates exercises for this population. The aim of this study is to investigate the effects of clinical pilates exercise program on postural control and balance in individuals with Parkinson's disease.


Description:

The patients will be randomly assigned into two groups: Clinical Pilates (CP) Group and Classic Physiotherapy (CF) Group. Both groups will be treated for 8 weeks. The evaluation of the patients will be done before the beginning of exercise program and will be repeated at the end. Static balance of patients will be evaluated with Single Leg Stance Test and Tandem Stance Test, dynamic balance with Functional Reach Test (FRT) and 30 second Chair Stand Test. Postural control and balance will also be evaluated with Berg Balance Scale and functional capacity by Timed Up and Go Test. Symptom severity and treatment complications of the patients will be evaluated with United Parkinson's Disease Rating Scale.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 21, 2020
Est. primary completion date January 21, 2020
Accepts healthy volunteers No
Gender All
Age group 45 Years to 70 Years
Eligibility Inclusion Criteria: - Stage 2-3 of Modified Hoehn & Yahr Scale - 26 or> 26 points from the Mini Mental test - Having at least 2 years Parkinson Disease Exclusion Criteria: - Serious mental and psychological disorder - Significant musculoskeletal disorders - Lower extremity deformation - Having another neurological disease - Drug or dose change during treatment

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Clinical Pilates
This exercise model focus on the awareness of the neutral position of the spine and strengthen the deep postural muscles of the spine. Training of trunk muscles is emphasized and trunk stabilization is achieved and more difficult activities are initiated and thus, body awareness is improved. There are general principles to be followed during exercises. These; The principle of concentration is respiration, central focus, control, stability and isolation. These principles are achieved by simultaneous muscle activation of muscles responsible for trunk stabilization (multifidus, diaphragm, transversus abdominis and pelvic floor muscles). In order for an exercise to become a clinical pilates exercise, trunk stabilization must be ensured and breath control should be established in each exercise.
Classic 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 One leg stance test This test is used to measure balance and standing ability and gives an idea about the individual's ability to balance and the risk of falling. Test measures how many seconds the patient can stand on one leg. 5 minutes
Primary Tandem stance test It is a test that evaluates the static balance by narrowing the ground contact area. The heel of one foot is adjusted to the end of the other foot. Patient is asked to try to stand without loss of balance and the time is recorded in seconds. 5 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 Sit-to-stand test This test evaluates the patient's sit-up activity, lower extremity strength and dynamic balance. The patient's number of sitting and getting up within 30 seconds gives the test score. 5 minutes
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
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