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

NCT06390163 | Completed

• 1 other identifier: KA-23038
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Idiopathic Parkinson Disease

Keywords

Balance; Gait; Cognitive Function; Sensory-perception-motor training

Outcome Measures

Primary Outcomes (8)

• Static Posturography

  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

  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

  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

  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

  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

  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

  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

  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

Study Arms (2)

Sensory-motor Integration Training

EXPERIMENTAL

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

Standart Care

NO INTERVENTION

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.

Interventions

Sensory-Motor Integration Training OTHER

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.

Sensory-motor Integration Training

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Related Publications (2)

• Gandolfi M, Munari D, Geroin C, Gajofatto A, Benedetti MD, Midiri A, Carla F, Picelli A, Waldner A, Smania N. Sensory integration balance training in patients with multiple sclerosis: A randomized, controlled trial. Mult Scler. 2015 Oct;21(11):1453-62. doi: 10.1177/1352458514562438. Epub 2015 Jan 12.

  PMID: 25583852 BACKGROUND

• Taghizadeh G, Azad A, Kashefi S, Fallah S, Daneshjoo F. The effect of sensory-motor training on hand and upper extremity sensory and motor function in patients with idiopathic Parkinson disease. J Hand Ther. 2018 Oct-Dec;31(4):486-493. doi: 10.1016/j.jht.2017.08.001. Epub 2017 Nov 14.

  PMID: 29150384 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Ayla Fil Balkan, Assoc.Prof

  Hacettepe University

  STUDY DIRECTOR

• 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

  STUDY CHAIR

• Büşra Seçkinoğulları Korkusuz, MSc

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: April 30, 2024
• Study Start: May 5, 2024
• Primary Completion: October 20, 2024
• Study Completion: October 30, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)