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

NCT ID: NCT06390163

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-05

Study Completion Date

2024-10-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Idiopathic Parkinson Disease

Keywords

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Balance Gait Cognitive Function Sensory-perception-motor training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Sensory-Motor Integration Training

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Busra Seckinogullari Korkusuz

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayla Fil Balkan, Assoc.Prof

Role: STUDY_DIRECTOR

Hacettepe University

Süleyman Korkusuz, PhD

Role: STUDY_CHAIR

Atılım University

Ayşenur Özcan, MSc

Role: STUDY_CHAIR

Çankırı Karatekin University

Gül Yalçın Çakmaklı, Assoc.Prof.

Role: STUDY_CHAIR

Hacettepe University

Öznur Yiğit, Assisst.Prof

Role: STUDY_CHAIR

Hacettepe University

Bülent Elibol, Prof.Dr.

Role: STUDY_CHAIR

Hacettepe University

Büşra Seçkinoğulları Korkusuz, MSc

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

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Hacettepe University

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 25583852 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29150384 (View on PubMed)

Other Identifiers

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KA-23038

Identifier Type: -

Identifier Source: org_study_id