Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06390163
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-03-01
Brief Title:
Effects of Sensory-Motor Integration Training in Patients with Idiopathic Parkinsons Disease
Sponsor:
Hacettepe University
Organization:
Hacettepe University
Study Overview
Official Title:
Investigation the Effects of Sensory-Motor Integration Training on Cognitive Functions Balance and Gait in Patients with Idiopathic Parkinsons Disease
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None