Effects of Sensory-Motor Integration Training in Patients with Idiopathic Parkinson's Disease

December 21, 2024 updated by: Busra Seckinogullari Korkusuz, Hacettepe University

Investigation the Effects of Sensory-Motor Integration Training on Cognitive Functions, Balance and Gait in Patients with Idiopathic Parkinson's Disease

The goal of this single blind randomized controlled trial is to investigate the effect of sensory-motor integration training on cognitive functions, balance and gait in patients with Parkinson Disease?

The main questions it aims to answer are:

  • Does sensory-motor integration training have an effect on balance in patients with Parkinson Disease?
  • Does sensory-motor integration training have an effect on cognitive functions in patients with Parkinson Disease?
  • Does sensory-motor integration training have an effect on gait in patients with Parkinson Disease? Patients in the control group will be asked to continue their routine lives and return for evaluation after 8 weeks. Individuals in the control group will be followed without any additional treatment or advice. Patients in the study group will receivesensory-motor integration training for 60 minutes, 3 days a week for 8 weeks, in addition to their routine lives. No additional recommendations will be given to individuals in either group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

40 patients will be included in the study. Patients who agree to participate in the study will be divided into two groups, study and control groups, by using a table of random numbers, ensuring that there are equal numbers of patients in each group. Demographic and clinical information of all patients participating in the study will be recorded. Montreal Cognitive Assessment Test and Modified Hoehn Yahr Staging Scale scores of all participants will be recorded by the neurologist and eligible patients will be included in the study. Evaluations to be applied to the groups within the scope of the study: Unified Parkinson Disease Rating Scale Part 3 , Static posturography measurement, Functional Reaching Test , Dynamic Gait Index , Rapid Mild Cognitive Impairment Screening, Stroop Test, Symbol Digit Modalities Test , Clock Drawing Test. Assessments will be made during the patients on period (approximately 60 minutes after medication intake). On the first day of the study, demographic information will be recorded in both groups and the patients participating in the study will be randomized. After randomization, patients in the control group will be asked to continue their routine lives and return for evaluation after 8 weeks. Individuals in the control group will be followed without any additional treatment or advice. Patients in the study group will receive sensory-perceptual-motor training for 60 minutes, 3 days a week for 8 weeks, in addition to their routine lives. No additional recommendations will be given to individuals in either group. Patients will be excluded from the study if they participate in any physiotherapy and rehabilitation program during the study. Patients in both groups will be evaluated a total of 3 times: at the beginning of the study, at the end of the study (at week 8), and 4 weeks after the end of the study (at week 12).

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being diagnosed with idiopathic Parkinson's disease
  • Being between the ages of 45-75
  • Being between stage 2-3 according to the Modified Hoehn-Yahr Staging Scale
  • Having a score > 21 on the Montreal Cognitive Assessment Scale
  • Being literate in Turkish
  • No drug or dose changes throughout the study.
  • Not having participated in any physiotherapy or rehabilitation program in the last 6 months.
  • Volunteering to participate in the study

Exclusion Criteria:

  • Presence of other neurological diseases
  • Presence of vision problems (that cannot be compensated with the correct lens) or vestibular disorders that may affect balance, other than symptoms related to Parkinson's disease.
  • Serious comorbidities that affect balance and gait or cannot be controlled with life-threatening medication (Diabetes, Hypertension, Cardiopulmonary diseases)
  • Long-term corticosteroid use
  • Presence of orthopedic and systemic diseases that may affect participation in exercise

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sensory-motor Integration Training
Patients in the study group will receive sensory-motor integration training for 60 minutes, 3 days a week for 8 weeks, in addition to their routine lives.
Other: Sensory-Motor Integration Training
An exercise chain consisting of motor tasks, sensory stimuli and cognitive tasks will be created. Each session will include at least 3 motor tasks, 3 sensory stimuli and 3 cognitive tasks selected according to the patient's condition.
No Intervention: Standart Care
Patients in the control group will be asked to continue their routine lives and return for evaluation after 8 weeks. Individuals in the control group will be followed without any additional treatment or advice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Static Posturography
Time Frame: Baseline, week 8 and week 12
It measures postural stability while standing statically and dynamically. The device has a computer-connected force platform that measures the vertical forces applied on the patients' feet (center of pressure/COG) to measure the position of the center of gravity and postural control.
Baseline, week 8 and week 12
Modified Dynamic Gait Index
Time Frame: Baseline, week 8 and week 12
Index is used to evaluate and document the ability to respond to changing task demands during gait. An increase in the score indicates that the patient's walking ability is better.
Baseline, week 8 and week 12
Functional Reach Test
Time Frame: Baseline, week 8 and week 12
It is used to evaluate dynamic balance and anteroposterior stability. In the standing position, the arm is lifted 90° upwards and stretched forward as much as possible, without losing contact with the feet. Initially, the projection of the acromion and the 3rd metacarpal bone on the wall is marked. At the final point reached after reaching forward, the projection of the 3rd metacarpal bone on the wall is marked and the difference is calculated. In elderly individuals, there is a risk of falling if the reach distance is less than 25.4 cm, and there is a risk of serious falling if it is less than 15 cm.
Baseline, week 8 and week 12
Quick Mild Cognitive Impairment Screen
Time Frame: Baseline, week 8 and week 12
It consists of 6 subtests: orientation, registration, clock drawing, delayed recall, verbal fluency and logical memory. This has a high degree of sensitivity in detecting cognitive impairment. It is also quick to apply, taking 3 to 5 minutes. There are cutoff points that are adjusted for factors such as age and education level. The total score is 100, and a score below 62 points indicates cognitive impairment.
Baseline, week 8 and week 12
Symbol Digit Modalities Test
Time Frame: Baseline, week 8 and week 12
It is a test frequently used in clinics because it evaluates attention, visuo-spatial information processing speed and working memory. Test is based on matching meaningless geometric shapes with certain numbers. The first 10 symbols are considered trials. Then the test starts and the person gets points for the correct marking he makes within 90 seconds. The maximum score is 60. Turkish Standardization of the test battery containing the relevant test was made and permission was obtained from the relevant authors
Baseline, week 8 and week 12
Stroop Test
Time Frame: Baseline, week 8 and week 12
The Stroop Test, which also measures the ability to change perceptual setup and response under disruptive influence, information processing speed and attention (especially selective attention).Increasing time and error indicates lower cognitive level.
Baseline, week 8 and week 12
Clock Drawing Test
Time Frame: Baseline, week 8 and week 12
Clock drawing test is an easy, quickly applicable, paper-and-pencil test with high validity and reliability used to evaluate visual-motor functions, planning, sequencing and abstract thinking skills. The Shulmann method will be used for scoring and this method evaluates out of a total of 5 points. An increase in the score indicates a better cognitive level.
Baseline, week 8 and week 12
Movement Disorders Society Unified Parkinson's Disease Rating Scale - Part 3
Time Frame: Baseline, week 8 and week 12
It is the revised form developed in 1980, by the Movement Disorders Association in 2008. It is a revised version that will eliminate the uncertainties present in scale and include current scientific developments. The number of questions, which was 42 in scale, was increased to 50 , and questions with yes/no options were removed because they caused structural inconsistency, and all questions were scored between 0 and 4. In our study, only the 3rd Part, which includes the Motor examination, will be used.
Baseline, week 8 and week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Study Director: Ayla Fil Balkan, Assoc.Prof, Hacettepe University
  • Study Chair: Süleyman Korkusuz, PhD, Atılım University
  • Study Chair: Ayşenur Özcan, MSc, Çankırı Karatekin University
  • Study Chair: Gül Yalçın Çakmaklı, Assoc.Prof., Hacettepe University
  • Study Chair: Öznur Yiğit, Assisst.Prof, Hacettepe University
  • Study Chair: Bülent Elibol, Prof.Dr., Hacettepe University
  • Principal Investigator: Büşra Seçkinoğulları Korkusuz, MSc, Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2024

Primary Completion (Actual)

October 20, 2024

Study Completion (Actual)

October 30, 2024

Study Registration Dates

First Submitted

March 1, 2024

First Submitted That Met QC Criteria

April 28, 2024

First Posted (Actual)

April 30, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 21, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA-23038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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