Computer-based Cognitive Training for Parkinson Disease

Study Overview
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Brief Summary
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Parkinson's Disease (PD) is a neurodegenerative, progressive illness. It is a multi-system disease that influences not only the motor but also the cognitive and autonomic systems. The main cognitive impairment in individuals with PD is found in executive function (EF). EF is defined as a set of cognitive skills necessary for planning, monitoring and executing sequences of complex activities. The primary study hypothesis is that computer-based training aimed at improving executive function will have a beneficial effect on gait functions.

Detailed Description
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Parkinson Disease (PD) is a neurodegenerative, progressive illness. It is a multi-system disease that influences not only the motor but also the cognitive and autonomic systems. The main cognitive impairment in individuals with PD is found in executive function (EF). EF is defined as a set of cognitive skills necessary for planning, monitoring and executing sequences of complex activities. Previous studies have revealed some relation between cognitive states and physical functions in healthy adults. Few studies have examined the effect of computer-based cognitive training on various populations. These studies showed a positive emotional-cognitive effect in those populations. This type of intervention plan was also applied to PD patients. However, there are no reports on the effect of intentional cognitive training on gait functions. The purpose of the study is to assess whether cognitive training, designed to improve EF ability, can also improve gait function in PD patients.

Official Title
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Effects of Computer-based Cognitive Training on Gait Function in Individuals With Parkinson Disease

Conditions
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Parkinson Disease, Gait

Intervention / Treatment
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* Other: Computerized cognitive training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Idiopathic PD. Aged 50-80, living in north region of Israel. Receive regular medications for PD. Not suffering from irregular cognitive disturbance or MMSE<25. Measured 1-3 on the Hoehn & Yahr scale. Have access to a computer and the ability to operate it. Exclusion Criteria: Brain operation, including DBS transplant. History of orthopedic problems that can impair gait (hip/knee fractures and back problems). Orthopedic operation on lower limbs performed no later than six months prior to the beginning of the study. Unbalanced general health: uncontrolled diabetes or blood pressure, etc. Inability to walk independently. Immunodeficiency diseases, active cancer, ischemic diseases. Vision impairment, partial/full blindness. Having participated in similar research or cognitive assessment during the previous year. Have received cognitive or gait training under physical therapy or other programs.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computerized cognitive training<br>A 12 week computerized cognitive training | Other: Computerized cognitive training<br>* A 12 week computerized cognitive training at home with the Attengo™ software program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait Function | At enrollment eligible individuals will undergo a thorough baseline assessment using a predefined set of tests and performance measurements. Within a week after enrollment each individual will receive guided training on the use of the intervention tool, the Attengo™ software program. Thereafter they will train at their homes, at least three times a week, for a period of 12 weeks. Follow up assessments will be performed within a week of the end of the training period and 4 weeks thereafter to check for long-term cognitive and motor changes. | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Executive function | At enrollment eligible individuals will undergo a thorough baseline assessment using a predefined set of tests and performance measurements. Within a week after enrollment each individual will receive guided training on the use of the intervention tool, the Attengo™ software program. Thereafter they will train at their homes, at least three times a week, for a period of 12 weeks. Follow up assessments will be performed within a week of the end of the training period and 4 weeks thereafter to check for long-term cognitive and motor changes. | 18 weeks | 
| Quality of life. | At enrollment eligible individuals will undergo a thorough baseline assessment using a predefined set of tests and performance measurements. Within a week after enrollment each individual will receive guided training on the use of the intervention tool, the Attengo™ software program. Thereafter they will train at their homes, at least three times a week, for a period of 12 weeks. Follow up assessments will be performed within a week of the end of the training period and 4 weeks thereafter to check for long-run cognitive and motor changes. | 18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Computerized Cognitive training, Quality of life, Gait Function, Executive Function