- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06848257
Posture Exercises in Parkinson's Disease
The Effect of Postural Exercises on the Perception of Verticality in Parkinson's Disease
The research was planned as a quasi-experimental study to investigate the effects of postural exercises on body image and neck and trunk position sense in Parkinson's patients.
It was decided to conduct the study with Parkinson's patients over the age of 50 who applied to the neurology clinic. After the power analysis for the research, it was planned to reach 36 participants. Participants' consent to participate in the study will be obtained through the Informed Volunteer Consent Form prepared by the researchers. Demographic information of participants who consent to participate in the study will be collected. Then, the disease levels and severity of the participants will be determined using the Modified Hoehn Yahr Staging Scale and the Unified Parkinson's Disease Assessment Scale. Subjective Visual Vertical Perception, Subjective Postural Perception and Subjective Haptic Perception evaluations to evaluate the body image of patients; Clinometer application and neck and trunk proprioception evaluations will be applied as preliminary tests to evaluate neck and trunk position sense. Posture exercises planned by the researchers will be applied to the participants, whose pre-tests are completed, three days a week for eight weeks. Preliminary tests performed after eight weeks of exercise will be repeated. All data obtained will be recorded in the Participant Data Record form. Differences in changes in tests performed at eight-week intervals will be investigated with appropriate statistical methods.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey, 06530
- Yuksek Ihtisas University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being over 50 years old,
- Being diagnosed with Parkinson's disease by a physician,
- Stage 1-4 according to the modified Hoehn-Yahr staging scale
- Having received 24≥ from the Mini Mental test
Exclusion Criteria:
- Presence of another accompanying neurological disease,
- Having significant musculoskeletal system problems,
- Having any known cognitive problem or having a score of ≤23 on the Mini Mental Test
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Clinic research
|
postural exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluations about Parkinson's disease
Time Frame: All evaluations will be done before and after the treatment (8 weeks)
|
Disease staging of individuals will be done with the Modified Hoehn and Yahr Scale (MH&YS).
In this scale, patients are divided into 5 main categories according to their level of independence status.According to the scale, patients who can walk without support (at most stage 3) will be included in the study.
And disease severity will be measured by Unified Parkinson's Disease Rating Scale(UPDRS) .The scale consists of 4 sections to evaluate different systems.
These are; emotion-thought (total 16 points), motor (total 92 points), daily life (total 52 points), treatment and complications (total 23 points).
Each evaluation step is scored between 0 and 4. A low total score indicates that the severity of the disease is low, while an increase in the total score indicates that the disease is severe.
|
All evaluations will be done before and after the treatment (8 weeks)
|
|
Subjective verticality perception evaluations
Time Frame: All evaluations will be done before and after the treatment (8 weeks)
|
Assessment of Subjective Vertical Perception:The Bucket Test evaluates subjective visual verticality by having participants align a vertical line inside a bucket without external visual cues.For Postural Vertical, an inclinometer measures deviations as participants adjust their torso to perceived verticality in 0°, 30° right, and 30° left positions.Haptic Vertical is tested by blindfolded participants aligning a rod to reference angles (0°, 45° left, 45° right).Scored by taking the absolute value of the deviations from three trials
|
All evaluations will be done before and after the treatment (8 weeks)
|
|
proprioception evaluations
Time Frame: All evaluations will be done before and after the treatment (8 weeks)
|
Position Sense (proprioception) is assessed by repositioning the neck (C7) and trunk (L1) to a 30° flexion target.
Scored by taking the absolute value of the deviations from three trials.
|
All evaluations will be done before and after the treatment (8 weeks)
|
|
Demographic characteristics of the individuals participating in the study
Time Frame: All evaluations will be done before and after the treatment (8 weeks)
|
Demographic information of the patients such as age(years), height (in meters) and weight (in kilograms) and education level (primary school, secondary school, high scool, etc) will be recorded.
Weight and height will be used to calculate Body mass index (BMI) (kg/m^2).
BMI will be used to compare body compositions of patients.
Mini Mental Test; used to evaluate cognitive performance.Those who score 24 points or above on the test (being able to understand and apply the given commands) will be included in the study.
|
All evaluations will be done before and after the treatment (8 weeks)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/03/10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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