Clinical trial NCT06390163: Effects of Sensory-Motor Integration Training in Patients with Idiopathic Parkinson's Disease
Official title: Investigation the Effects of Sensory-Motor Integration Training on Cognitive Functions, Balance and Gait in Patients with Idiopathic Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Parkinson Disease
Keywords: Balance
Gait
Cognitive Function
Sensory-perception-motor training
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Static Posturography
timeFrame: Baseline, week 8 and week 12
measure: Modified Dynamic Gait Index
timeFrame: Baseline, week 8 and week 12
measure: Functional Reach Test
timeFrame: Baseline, week 8 and week 12
measure: Quick Mild Cognitive Impairment Screen
timeFrame: Baseline, week 8 and week 12
measure: Symbol Digit Modalities Test
timeFrame: Baseline, week 8 and week 12
measure: Stroop Test
timeFrame: Baseline, week 8 and week 12
measure: Clock Drawing Test
timeFrame: Baseline, week 8 and week 12
measure: Movement Disorders Society Unified Parkinson&#39;s Disease Rating Scale - Part 3
timeFrame: Baseline, week 8 and week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Ayla Fil Balkan, Assoc.Prof
role: STUDY_DIRECTOR
affiliation: Atılım University
name: Süleyman Korkusuz, PhD
role: STUDY_CHAIR
affiliation: Çankırı Karatekin University
name: Ayşenur Özcan, MSc
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Gül Yalçın Çakmaklı, Assoc.Prof.
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Öznur Yiğit, Assisst.Prof
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Bülent Elibol, Prof.Dr.
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Büşra Seçkinoğulları Korkusuz, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.