search
Back to results

The Effect of Clinical Pilates Training on Balance and Postural Control of People With Parkinson's Disease.

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Clinical Pilates
Classic 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

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • European University of Lefke

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Clinical Pilates

Classic Physiotherapy

Arm Description

Participants in this group will receive twice a week, total 8 weeks of clinical pilates exercise program. Each session will take 45 minutes.

Participants in this group will receive twice a week, total 8 weeks of classic physiotherapy exercise program. Each session will take 45 minutes.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 19, 2019
Last Updated
March 10, 2021
Sponsor
European University of Lefke
search

1. Study Identification

Unique Protocol Identification Number
NCT04063605
Brief Title
The Effect of Clinical Pilates Training on Balance and Postural Control of People With Parkinson's Disease.
Official Title
The Effect of Clinical Pilates Training on Balance and Postural Control of People With Parkinson's Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 16, 2019 (Actual)
Primary Completion Date
January 21, 2020 (Actual)
Study Completion Date
January 21, 2020 (Actual)

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

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

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

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 8 weeks.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clinical Pilates
Arm Type
Experimental
Arm Description
Participants in this group will receive twice a week, total 8 weeks of clinical pilates exercise program. Each session will take 45 minutes.
Arm Title
Classic Physiotherapy
Arm Type
Active Comparator
Arm Description
Participants in this group will receive twice a week, total 8 weeks of classic physiotherapy exercise program. Each session will take 45 minutes.
Intervention Type
Other
Intervention Name(s)
Clinical Pilates
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Classic Physiotherapy
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
One leg stance test
Description
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.
Time Frame
5 minutes
Title
Tandem stance test
Description
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.
Time Frame
5 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
Sit-to-stand test
Description
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.
Time Frame
5 minutes
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beliz Belgen Kaygisiz, PT, PhD
Organizational Affiliation
European University of Lefke
Official's Role
Principal Investigator
Facility Information:
Facility Name
European University of Lefke
City
Mersin
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34726472
Citation
Coban F, Belgen Kaygisiz B, Selcuk F. Effect of clinical Pilates training on balance and postural control in patients with Parkinson's disease: a randomized controlled trial. J Comp Eff Res. 2021 Dec;10(18):1373-1383. doi: 10.2217/cer-2021-0091. Epub 2021 Nov 2.
Results Reference
derived

Learn more about this trial

The Effect of Clinical Pilates Training on Balance and Postural Control of People With Parkinson's Disease.

We'll reach out to this number within 24 hrs