NCT06848257

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 27, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2025

Completed
Last Updated

March 3, 2025

Status Verified

February 1, 2025

Enrollment Period

1 month

First QC Date

January 14, 2025

Last Update Submit

February 26, 2025

Conditions

Keywords

ParkinsonPostural exercisesVerticalityPosition sense

Outcome Measures

Primary Outcomes (4)

  • Demographic characteristics of the individuals participating in the study

    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)

  • Evaluations about Parkinson's disease

    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

    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

    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)

Study Arms (1)

Clinic research

EXPERIMENTAL
Other: Exercise

Interventions

postural exercises

Clinic research

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuksek Ihtisas University

Ankara, 06530, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asistant Professor

Study Record Dates

First Submitted

January 14, 2025

First Posted

February 27, 2025

Study Start

July 15, 2023

Primary Completion

August 15, 2023

Study Completion

May 15, 2025

Last Updated

March 3, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

There is no reason.

Locations